The current study is based on the US National Longitudinal Lesbian Family Study (NLLFS), which was designed to document the development of the first generation of lesbian families with children conceived through donor insemination. Data were collected in five waves, first at insemination or during pregnancy, and subsequently when the index children were 2, 5, 10 and 17 years old. The study is ongoing, with a 93% retention rate to date. The purpose of the current investigation was to assess changes in psychological adjustment of the index offspring between the time that they were 10 and 17 years old (T4 and T5) and to examine the effects of having a known or an as-yet-unknown donor.
METHODS
The total T5 sample consisted of 78 adolescents. The mothers in 74 families completed a Child Behaviour Checklist (CBCL) on their offspring at both T4 and T5: 26 of these offspring had been conceived through known sperm donors and 48 through unknown donors. Changes in psychological adjustment were assessed through computations of stability coefficients between T4 and T5 on all CBCL subscales, and by means of a general linear model (GLM).
RESULTS
On 10 out of 11 CBCL subscales, the stability coefficients were not significantly different for adolescents with known and unknown donors. Findings from the GLM showed that no main effect for donor type was found; for offspring in both donor groups thought problems and rule-breaking behaviour were higher and scores on social problems and aggressive behaviour were lower at T5 than T4.
CONCLUSIONS
The development of psychological well-being in the offspring of lesbian mothers over a 7-year period from childhood through adolescence is the same for those who were conceived through known and unknown donors.
Not being able to procreate has severe social and economic repercussions in resource-poor countries. The purpose of this research was to explore the consequences of female and/or male factor infertility for men and women in Rwanda.
METHODS
Both quantitative and qualitative methods were used. Couples presenting with female and/or male factor infertility problems at the infertility clinic of the Kigali University Teaching Hospital (n= 312), and fertile controls who recently delivered (n= 312), were surveyed about domestic violence, current and past relationships and sexual functioning. In addition, five focus group discussions were held with a subsample of survey participants, who were either patients diagnosed with female- or male-factor fertility or their partners.
RESULTS
Domestic violence, union dissolutions and sexual dysfunction were reported more frequently in the survey by infertile than fertile couples. The psycho-social consequences suffered by infertile couples in Rwanda are severe and similar to those reported in other resource-poor countries. Although women carry the largest burden of suffering, the negative repercussions of infertility for men, especially at the level of the community, are considerable. Whether the infertility was caused by a female factor or male factor was an important determinant for the type of psycho-social consequences suffered.
CONCLUSIONS
In Rwanda, as in other resource-poor countries, infertility causes severe suffering. There is an urgent need to recognize infertility as a serious reproductive health problem and to put infertility care on the public health agenda.
This study examines whether social age deadlines exist for childbearing in women and men, how they vary across countries, whether they are lower than actual biological deadlines and whether they are associated with childbearing at later ages and the availability of assisted reproduction techniques (ARTs).
METHODS
This study is based on the European Social Survey, Round 3 (2006–2007), which covers 25 countries. Data were gathered on social age deadlines for childbearing in women (21 909 cases) and men (21 239 cases) from samples of representative community-dwelling populations aged 15 and older.
RESULTS
Social age deadlines for childbearing were perceived more frequently for women than men. These deadlines are often lower than actual biological limits, and for women and men alike: 57.2% of respondents perceived a maternal social age deadline ≤40 years of age; 46.2% of the respondents perceived a paternal social age deadline ≤45 years of age. There is also considerable variability in deadlines across countries, as well as within them. At the country level, the presence of social age deadlines for the childbearing of women was negatively associated with birth rates at advanced ages and the prevalence of ART, and later deadlines were positively associated with these factors.
CONCLUSIONS
It is important to understand the factors that increase and limit late fertility. While biological factors condition fertility, so do social expectations. These findings provide widespread evidence across Europe that social limits exist alongside biological ones, though both sets of factors are more binding for women.
Two surgical approaches are usually employed in the treatment of deep infiltrating endometriosis of the rectum (DIER): colorectal resection removing the rectal segment affected by the disease, and nodule excision either without opening the rectum (shaving) or by removing the nodule along with the surrounding rectal wall (full thickness or disc excision). Although the present available data are from retrospective series reported by surgeons who generally perform only one technique, there is no evidence to support the risk of recurrences as a valid argument in favour of colorectal resection over rectal nodule excision. The advantage of a lower morbidity associated with nodule excision is not necessarily at the cost of an increased rate of pain recurrences, especially in women benefiting from post-operative medical treatment. The symptom-guided surgical approach in DIER primarily focuses on the relief of digestive symptoms and pelvic pains, rather than on mandatory ‘carcinologic’ resection of lesions. In addition, the risk of new post-operative unpleasant symptoms as a result of a compulsory and systematic excision of all endometriotic foci may be avoided. In a majority of cases, pelvic anatomy and digestive function can be restored by shaving or disc excision, as well as by colorectal resection; thus digestive complaints can be resolved even when the rectum is conserved. The most accurate evaluation of the results of DIER surgery should be provided by post-operative evolution in digestive function. Even though qualityoflife is improved for the majority of patients managed by colorectal resection, the question is whether or not a greater health improvement can be achieved by performing nodule excision, which avoids various post-operative and functional digestive complications. In addition, continuous medical treatment leads to a decrease in endometriotic nodules and prevents post-operative pain recurrences. Instead of choosing between medical and surgical management in the treatment of DIER, it is most likely that the two therapies should be associated.
Fertility patients often struggle with decisions about disposition of embryos remaining after fertility treatment. We aimed to identify predictors and correlates of decisional conflict among patients facing these decisions.
METHODS
We analyzed results from a survey of 2210 patients from nine geographically diverse US fertility clinics. The main outcome measure was decisional conflict about embryo disposition, as measured by the decisional conflict scale (DCS).
RESULTS
Of 1244 respondents who returned the survey, 1005 with cryopreserved embryos and DCS scores were included in the analysis. Of the respondents, 39% reported high decisional conflict (DCS ≥ 37.5). Thoughts about future childbearing were associated with high decisional conflict: respondents who were either uncertain about whether to have a baby in the future or sure they did not want to have a baby were at higher odds of high decisional conflict than participants who desired a baby [adjusted odds ratio (aOR) = 3.93, P < 0.001 and aOR = 1.69, P = 0.04, respectively]. Also associated with high decisional conflict were being likely to have embryos thawed and discarded (aOR = 2.08, P < 0.001), donated for research (aOR = 1.66, P = 0.01) or frozen ‘forever’ (aOR = 1.90, P = 0.01); being likely to choose compassionate transfer if it were available (aOR = 1.65, P = 0.03); attributing high, but not full, moral status to human embryos; not having enough information; and not being satisfied with the informed consent process.
CONCLUSIONS
Decisional conflict about frozen embryo disposition differs according to reproductive preferences that may vary according to stage of treatment. Informed consent for embryo disposition should be revisited periodically, with serious discussions about disposition after childbearing is complete.
This study examined the motivations and experiences of anonymous donors who decide to make themselves open to contact with their donor offspring.
METHODS
Online questionnaires were completed by 63 sperm donors and 11 oocyte donors recruited via the Donor Sibling Registry (http://www.donorsiblingregistry.com/), a US-based international registry that facilitates contact between donor-conceived offspring and their donors.
RESULTS
Donors' main reasons for donating were financial payment and wanting to help others. Sperm donors had donated between 1 and 950 times (median = 100) and oocyte donors had donated between 1 and 5 times (median = 2). The majority of sperm donors and more than one-third of oocyte donors expressed concerns about having donated. These concerns were mainly about the well-being of any children conceived using their gametes and not being able to make contact with them. Most sperm and oocyte donors felt that it was important to know how many offspring had been born using their donation, and 51% of sperm donors and 46% of oocyte donors wanted identifying information. All of the donors who had contact with their donor offspring reported positive experiences and the majority continued to have regular contact.
CONCLUSIONS
Although the sample may not be representative of all anonymous donors, this study highlights the importance of donors having access to information about their donor offspring and the positive consequences that may arise when contact is made.
During implantation, the human embryo invades endometrial stromal tissues, reducing the intercellular connections among epithelial cell layers. Since Eph–ephrin interaction can induce repulsive forces to control cell position and movement, we examined the possible involvement of this system in intercellular dissociation among endometrial epithelial cells.
METHODS
The expression of Eph A receptor on human endometrial epithelial cells and endometrial carcinoma-derived Ishikawa cells was examined by RT–PCR, immunohistochemistry and western blotting. The effects of recombinant ephrin A1 on Eph A2 phosphorylation in Ishikawa cells were also examined by western blotting. A permeability assay was performed to determine the effects of ephrin A1 on cell-to-cell adhesion.
RESULTS
Eph A1, A2 and A4 mRNAs were detected in human endometrial epithelial cells and Ishikawa cells, and ephrin A1 was present in human blastocysts. Immunohistochemical staining showed that Eph A1, A2 and A4 receptors were expressed on the cell surface region of luminal and glandular epithelial cells in human endometrium in both the proliferative and secretory phase. The presence of Eph A2 protein in the human endometrium was confirmed by western blot analysis. Recombinant ephrin A1 was bound to Ishikawa cells and induced phosphorylation of Eph A2 expressed in Ishikawa cells. In addition, stimulation by ephrin A1 for 20 min increased the permeability of monolayer Ishikawa cells versus control cultures (P < 0.01), without affecting cell viability.
CONCLUSIONS
This study demonstrated that the Eph–ephrin A system can promote intercellular dissociation in Ishikawa cells suggesting an important role in the initial step of embryo implantation by opening the endometrial epithelial cell barrier.
At present, non-invasive methods are not comprehensive enough to enable urologists to predict sperm retrieval results accurately in patients with non-obstructive azoospermia (NOA). Our aim was to improve the prediction accuracy of sperm retrieval by using leptin and artificial neural networks (ANNs).
METHODS
Data from May 2004 to July 2010 for 280 patients with NOA were reviewed and assigned into the training and testing set for ANNs. All patients underwent standard diagnostic infertility evaluation and testicular sperm extraction (TESE). Twelve factors were recorded as the input variables for ANNs:
testicular volume,
semen volume, seminal pH, seminal alpha-glucosidase and fructose,
serum hormones including FSH, LH, total testosterone (TT), prolactin, estradiol,
serum and seminal leptin. Three ANN models were constructed with the following input variables: ANN1-
, ANN2-
and ANN3-
. The prediction accuracy for FSH, leptin and ANN models was compared by receiver operating characteristic (ROC) curve analysis.
RESULTS
All ANN models were better than FSH. ANN1 had the largest area under the curve (AUC =0.83) and demonstrated significant improvement compared with FSH (AUC =0.63, P< 0.01) and leptin (AUC =0.59, P< 0.01).
CONCLUSIONS
ANNs improve the prediction accuracy of sperm retrieval. Although the leptin AUC is low, combined use of leptin and FSH can significantly improve the prediction accuracy for sperm recovery in NOA patients. Leptin may be a good assistant marker for diagnosing NOA. However, studies with larger numbers of patients are required to confirm the improved predictive performance of ANNs.
Grafting of frozen-thawed testicular tissue has been suggested as a novel fertility preservation method for patients undergoing gonadotoxic treatments. However, this technique still needs further optimization before any clinical application. So far, grafting of human testicular tissue has only been performed to the back skin of nude mice and has shown spermatogonial stem-cell survival and occasionally differentiation up to primary spermatocytes. In this study, orthotopic grafting to mouse testes was evaluated as an alternative, and the effect of freezing and the donor's age was studied.
METHODS
Human testicular tissue was obtained from two prepubertal (aged 3 and 5) and two postpubertal (aged 12 and 13) boys. Both fresh and frozen-thawed testicular tissue was grafted to the testis of immuno-deficient nude mice. Four and nine months after transplantation, testes were analyzed by histology and immunohistochemistry.
RESULTS
Four and nine months after transplantation, spermatogonial stem cells were observed in all tissue grafts. Germ cell survival was found to be higher in xenografts from the older boys when compared with that from younger donors. Furthermore, no differentiation was observed in the xenografts from younger patients, but the grafts of two older donors showed differentiation up to the primary spermatocyte level, with the presence of secondary spermatocytes in the oldest donor 9 months after transplantation.
CONCLUSIONS
This xenografting study shows that intratesticular grafting results in high germ cell survival. In grafts derived from the older boys, meiotic activity was maintained in the xenografts for at least 9 months. Although difficult to conduct due to the scarcity of the tissue, more comparative research is needed to elucidate an optimal grafting strategy.
Misoprostol is an agent that may ripen the cervix in nonpregnant women. Here, we investigate whether vaginal misoprostol administered prior to intrauterine device (IUD) insertion reduces the number of failed insertions, insertion-related complications and pain during insertion.
METHODS
We conducted a double-blinded, multicenter randomized controlled trial among patients requesting an IUD. Nulli- and multi-parous women were included, and both copper-containing and levonorgestrel-releasing IUDs were used. Participants were allocated to either 400 µg misoprostol or placebo (administered 3h prior to IUD insertion). The primary outcome measure was failed insertion. Secondary outcome measures were insertion-related complications, pain, difficulty of insertion and side-effects.
RESULTS
Two hundred and seventy participants were randomized. After drop out for various reasons (mainly no show), 199 participants had an IUD inserted; 102 received misoprostol and 97 received placebo. Only three insertions failed; two in the misoprostol group and one in the placebo group [P = 0.59, relative risk (RR) 1.9, 95% confidence interval (CI) 0.2–20.6]. The overall incidence of insertion-related complications was 21.8% in the misoprostol versus 19.1% in the placebo group (mainly vasovagal-like reactions) and did not differ between groups (P = 0.65, RR 1.1, 95% CI 0.7–2.0). No difference in pain scores between groups was found. Side-effects were more common in the misoprostol group (P = 0.05, RR 1.3, 95% CI 1.0–1.7).
CONCLUSION
The study showed no benefit for use of misoprostol prior to IUD insertion. However, there is a tendency of possible harm regarding side-effects. Therefore, we would not recommend standard pretreatment with misoprostol.
The trial was registered in the European Clinical Trials Database EudraCT 2006-006897-60.
The aim of this study was to analyse the outcome of closed blastocyst vitrification of embryos biopsied at the cleavage stage.
METHODS
Vitrification of supernumerary blastocysts was performed using the closed CBS-VIT High Security straws. Warming cycles (n= 100) for patients with preimplantation genetic diagnosis (PGD) and/or aneuploidy screening in the fresh cycle were analysed. The outcome parameters were morphological survival and transfer rates after warming, clinical pregnancy rate and implantation rate (with fetal heart beat). Clinical outcome was compared with two control groups of (i) vitrified/warming transfer cycles without embryo biopsy and (ii) fresh Day 5 transfer of biopsied embryos.
RESULTS
In total, 131 blastocysts were warmed with a morphological survival of 83.2% (109/131) and a transfer rate of 79.4% (104/131). Day 5 blastocysts survived significantly better (90.4%) than Day 6 blastocysts (70.8%, P< 0.01). No difference in survival rate was observed between early cavitating (89.2%) and full/expanded blastocysts (93.3%). In nine cycles, no blastocyst was available for transfer. The clinical pregnancy rate was 19.2% (15/78) after single-embryo transfer (SET) and 38.5% (5/13) after double-embryo transfer (DET). In SET, the implantation rate for blastocysts frozen on Day 5 was 13.7% (7/51), which was not different from the implantation rate of Day 6 blastocysts (18.5%, 5/27). The overall implantation rate of vitrified PGD biopsied blastocysts (14.4%) was comparable with that of vitrified blastocysts without biopsy (20.4%), but lower than the implantation rate obtained in the fresh PGD cycles (24.4%).
CONCLUSION
Blastocysts on Day 5 and Day 6 of development derived from biopsied embryos can be successfully vitrified using a closed system.
Evidence-based guidelines have been issued for ectopic pregnancy (EP), covering both diagnostic and therapeutic management. In general, guidelines aim to reduce practice variation and to improve quality of care. To assess the guideline adherence in the management of EP, we developed guideline-based quality indicators and measured patient care in various hospitals.
METHODS
A panel of experts and clinicians developed quality indicators based on recommendations from the Dutch guideline on EP management, using the systematic RAND-modified Delphi method. With these indicators, patient care was assessed in six Dutch hospitals between January 2003 and December 2005. For each quality indicator, a ratio for guideline adherence was calculated. Overall adherence was reported, as well as adherence per hospital type, i.e. academic, teaching and non-teaching hospitals.
RESULTS
Out of 30 guideline-based recommendations, 12 quality indicators were selected covering procedural, structural and outcome aspects of care. For 317 women surgically treated for EP, these aspects were assessed. Overall adherence to the guideline was 75%. The highest adherence (98%) was observed for performing transvaginal sonography during the diagnostic workup. The lowest adherence (21%) was observed for performing salpingotomy in case of contra-lateral tubal pathology. Wide variance in adherence (0–100%) existed between academic, teaching and non-teaching hospitals.
CONCLUSIONS
The overall guideline adherence was reasonable, with ample room for improvement in various aspects of care. Further research should focus on the barriers for guideline dissemination and adherence, to further improve the management of EP.
Thin-section oblique axial magnetic resonance imaging (MRI) is useful in staging endometrial and cervical carcinomas but there are no data on its contribution to assessing deep endometriosis. We evaluated the contribution of this MRI technique to diagnosis of uterosacral ligament (USL) endometriosis.
METHODS
In this retrospective study, two radiologists, who were blinded to the surgical and histological results, compared the results from conventional sagittal and axial MRI with those from conventional plus thin-section (3 mm) oblique axial MRI in 100 symptomatic patients. Descriptive statistical analyses including sensitivity, specificity, positive and negative predictive values, accuracy and positive and negative likelihood ratios were performed. Kappa for inter-observer agreement was calculated.
RESULTS
Conventional MR images for the diagnosis of left/right USL endometriosis revealed accuracies of 69/76 and 59/75%, sensitivities of 66/71 and 52/71% and specificities of 76/86 and 76/82% for senior and junior readers, respectively. The combination of conventional and thin-section oblique axial MR images revealed accuracies of 82/87 and 74/81%, sensitivities of 89/93 and 73/81% and specificities of 61/72 and 76/79%, for senior and junior readers, respectively. When conventional MRI combined with oblique axial T2-weighted MRI was compared with conventional MRI use only, significant differences in diagnostic accuracies were observed for right (P= 0.04) and left (P= 0.01) USL endometriosis.
CONCLUSIONS
Thin-section oblique axial T2-weighted imaging can improve the success of conventional MRI for assessment of USL endometriosis. Further prospective studies are required before this new MR protocol is performed routinely for suspected pelvic endometriosis.
Heavy menstrual bleeding and dysmenorrhea are two top complaints from women with symptomatic adenomyosis, yet their etiology is poorly understood. Tissue factor (TF) has been shown to be upregulated in endometriosis and at the endometrial bleeding sites of women with long-term progestin only contraception. We sought to investigate the expression and localization of TF in eutopic and ectopic endometrium of women with adenomyosis and in endometrium of women without adenomyosis. We also sought to determine the relationship, if any, between TF immunoreactivity and the amount of menses, uterus size and severity of dysmenorrhea.
METHODS
We retrieved tissue samples of eutopic and ectopic endometrium from 50 women with adenomyosis and of endometrium from 18 women without adenomyosis. The tissue sections were subjected to immunostaining and microscopic evaluation to assess the presence and localization of TF in both proliferative and secretory phases in both eutopic and ectopic endometrium and normal endometrium. Information on the amount of menses, severity of dysmenorrhea and other information were collected.
RESULTS
We found that TF immunoreactivity was significantly increased in both eutopic and ectopic endometrium as compared with normal endometrium. In addition, we found that the elevated TF immunoreactivity is associated with heavy menses and increased severity of dysmenorrhea.
CONCLUSIONS
These results suggest that TF is involved in adenomyosis-associated heavy menstrual bleeding and dysmenorrhea and thus may be a potential therapeutic target in treating symptomatic adenomyosis and perhaps also chronic pelvic pain in women with adenomyosis.
The aim of this study was to determine if oral contraceptive (OC) use affects body weight, body composition and metabolism in primates.
METHODS
Reproductive-age female rhesus monkeys of normal and obese BMI were studied to document baseline weight stability, then treated continuously with an OC (dosed to achieve equivalent human serum levels for a 30 µg ethinyl estradiol/150 µg levonorgestrel preparation) for 237 days. Monkeys were monitored for changes in body weight, levels of physical activity (measured by a triaxial Actical accelerometer), food/caloric intake, percent body fat (dual energy X-ray absorptiometry, DEXA) and metabolism (24 h metabolic rate and serum metabolic substrate and hormone concentrations).
RESULTS
All 10 monkeys completed the study protocol with no adverse events. While body weight (–0.73% change) and percent body fat (–1.78% change) of the normal BMI group did not significantly decrease from baseline, obese monkeys showed a significant decrease in body weight (–8.58% change, P < 0.01) and percent body fat (–12.13% change P = 0.02) with OC treatment. In both the obese (P = 0.03) and the normal BMI (P = 0.01) groups, there was a significant increase in basal metabolic rate with OC use. No changes were seen in food intake, activity level or % lean muscle mass with OC use for either BMI-based group.
CONCLUSIONS
Overall, OC use appears to cause a slight increase in basal metabolic rate in female monkeys, leading to a decrease in body weight and percent body fat in obese individuals.
Unexplained infertility is one of the most common diagnoses in fertility care. The aim of this study was to evaluate the outcome of current fertility management in unexplained infertility.
METHODS
In an observational, longitudinal, multicentre cohort study, 437 couples were diagnosed with unexplained infertility and were available for analysis. They were treated according to their prognosis using standing national treatment protocols: (i) expectant management–IUI–IVF (main treatment route), (ii) IUI–IVF and (iii) directly IVF. Primary outcome measures were: ongoing pregnancy rate, patient flow over the strategies, numbers of protocol violation and drop out rates. A secondary outcome measure was the prediction of ongoing pregnancy and mode of conception.
RESULTS
Of all couples 81.5% (356/437) achieved an ongoing pregnancy and 73.9% (263/356) of the pregnancies were conceived spontaneously. There were 408 couples (93.4%) in strategy-1, 21 (5.0%) in strategy-2 and 8 (1.8%) in strategy-3. In total, 33 (7.6%) couples entered the wrong strategy. There were 104 couples (23.8%) who discontinued fertility treatment prematurely: 26 on doctor's advice (with 4 still becoming pregnant) and 78 on their own initiative (with 33 still achieving a pregnancy). Predictors for overall pregnancy chance and mode of conception were duration of infertility, female age and obstetrical history.
CONCLUSIONS
Overall success rate in couples with unexplained infertility is high. Most pregnancies are conceived spontaneously. We recommend that if the pregnancy prognosis is good, expectant management should be suggested. The prognosis criteria for treatment with IUI or IVF needs to be investigated in randomized controlled trials.
Female sterilization is a widely used contraceptive method but in a small group of women, post-sterilization regret occurs. A dilemma for these women is the choice between surgical re-anastomosis and IVF. We evaluated the factors that affected pregnancy rate after laparoscopic tubal re-anastomosis for sterilization regret.
METHODS
We included women who underwent a laparoscopic tubal re-anastomosis between January 1997 and March 2008 at Máxima Medical Centre, The Netherlands, in a retrospective cohort study. Microsurgical laparoscopic re-anastomosis was performed using a serosa-muscular fixation/biological glue technique. The primary outcome was time to clinical pregnancy (TTP). Other outcomes were ongoing pregnancy and ectopic pregnancy. We studied whether clinical characteristics, including age, fertility history, BMI, semen quality, remaining tubal length and type of anastomosis, could predict the chance of pregnancy.
RESULTS
Data from 127 patients were analysed. The 40-month cumulative clinical pregnancy rate was 74%, whereas the ongoing pregnancy rate was 59%. There were five ectopic pregnancies (3.9%). Only age was found to influence the probability of a positive pregnancy test, hazard rate ratio (HRR): 0.32 [95% confidence interval (CI) 0.12–0.88] and ongoing pregnancy [HRR 0.21 (95% CI 0.05–0.87)]. Previous pregnancy increased pregnancy probability [HRR: 2.2 (95% CI 0.51–9.8)]. A total sperm motility count of <20 million was related to prolonged TTP.
CONCLUSIONS
Sutureless laparoscopic tubal re-anastomosis is an effective treatment for women who regret sterilization. Age, previous pregnancies and sperm quality should be considered when counselling for tubal sterilization reversal versus IVF. A randomized prospective trial comparing success rates of surgical reversal and IVF after sterilization regret should be conducted.
This study compares recipient couples' and donors' motivations towards the type of donation and attitudes concerning secrecy or disclosure of the mode of conception in three oocyte donation groups: couples and their donor for a known donation, couples and their donor for a permuted anonymous donation (known-anonymous) and couples without a donor, on a waiting list for a donation (anonymous).
METHODS
Data collected by two psychologists through semi-structured interviews of 135 recipient couples and 90 donors before oocyte donation were analysed retrospectively.
RESULTS
In known donation (42 couples), donors were preferentially family members with a blood tie (54.7%). Choosing their donor seemed mainly for the couple's reassurance rather than to access the child's origins as 50% wanted secrecy. On the other hand, in known-anonymous donation (48 couples), donors were more frequently chosen among friends (41.6%; P = 0.038). These couples were either open to disclosure (45.8%; P= 0.002) or remained hesitant (39.6%). In anonymous donation (45 couples), 49% chose not to seek a donor mostly in order to maintain secrecy towards the child (77.3%). Among the 51% who sought but could not find a donor, only 30.4% wanted secrecy. Recipients from North Africa and from Europe preferred anonymous or known-anonymous donation (83.3 and 75.6%), whereas sub-Saharan Africans opted more often for known donation (63%; P <0.001). Among Europeans (90 couples), 50% were in favour of disclosure compared with only 8.9% of recipients from North or sub-Saharan Africa (45 couples; P< 0.001).
CONCLUSIONS
A diversity of attitudes and cultural differences exist among recipient couples and donors regarding oocyte donation; this pleads for maintaining access to different types of oocyte donation as well as for psychological counselling prior to treatment.
In May 2009, the Italian Constitutional Court banned most of the limitations of a restrictive law regulating assisted reproduction technology on the grounds that it limited a couple's right to have access to the best possible medical treatment and reduce any possible higher risk of complications. The aim of the study was to compare our results in fresh cycles before and after this change.
MATERIALS AND METHODS
We analysed retrospectively 3274 IVF cycles: 2248 before and 1026 after the law was modified.
RESULTS
There was no significant difference between the two groups in terms of age, basal FSH levels, years of infertility, the number of previous cycles or the number of oocytes retrieved but the number of oocytes used (2.7 ± 0.6 versus 4.6 ± 1.8; P = <0.001), the number of embryos obtained (2.0 ± 0.9 versus 3.3 ± 1.8; P = <0.001) and transferred (2.2 ± 0.7 versus 2.3 ± 0.7; P = <0.001) were all higher after the removal of the previous restrictions, as was the pregnancy rate per started cycle (23.49% versus 20.42%; P = 0.047). Before modification of the law, the pregnancies were single in 74.11% of the cases (versus 71.43% afterwards), twins in 23.44% (versus 26.89%; P = 0.318) and triplets in 2.46% (versus 1.68%; P = 0.594).
CONCLUSIONS
Our preliminary results after the removal of the previous legal restrictions show a higher pregnancy rate per started cycle (3.7% represents a 15% difference) and a positive (albeit non-significant) trend towards a reduction in the number of multiple pregnancies.
First-line treatments for unexplained infertility traditionally include clomifene citrate (CC) or unstimulated intrauterine insemination (IUI). A recently published randomized controlled trial considered the effectiveness of CC and IUI in patients with unexplained infertility and found that neither treatment offered a superior live birth rate when compared with expectant management (EM). This paper reports the economic evaluation conducted alongside this trial in order to assess whether health care providers are gaining value for money in this clinical area.
METHODS
Five hundred and eighty women across five Scottish hospitals were randomized to either EM, CC or IUI for 6 months. The primary outcome measure was live births. Resource-use data were collected during the trial and costs were calculated from a UK National Health Service (NHS) perspective. Incremental cost–effectiveness ratios were calculated, expressed as cost per live birth, in order to compare the cost–effectiveness of CC and IUI with that of EM to treat unexplained infertility.
RESULTS
Live birth rates in the three randomized groups were: EM = 32/193 (17%), CC = 26/194 (13%) and IUI = 43/193 (22%). The mean (standard deviation) costs per treatment cycle were £0 for EM, £83 (£17) for CC and £98 (£31) for IUI. The mean treatment costs per patient for EM, CC and IUI were £12 (£117), £350 (£220) and £331 (£222), respectively. The cost per live birth for EM, CC and IUI was £72 (95% confidence interval £0–£206), £2611 (£1870–£4166) and £1487 (£1116–£2155), respectively. The incremental cost–effectiveness ratio for IUI versus EM was £5604 (–£12204 to £2227), with CC dominated by IUI.
CONCLUSIONS
Despite being more expensive, existing treatments such as empirical CC and unstimulated IUI do not offer superior live birth rates compared with EM of unexplained infertility. They are unlikely to be a cost-effective use of limited NHS resources. The study's main limitation is that it did not consider the psychological effects on couples.
