STUDY QUESTION

Was the delivery rate of ART cycles negatively affected by the enactment of the Law 40/2004 by the Italian Parliament which imposed a long list of restrictions for ART procedures?

SUMMARY ANSWER

This large and extensive comparative analysis of ART outcomes prior to and after the introduction of the Law 40 revealed a significant reduction in pregnancy and delivery rates per cycle, independent of age or other clinical variables, once the law went into effect.

WHAT IS KNOWN ALREADY

Several studies have been published on the effect of Law 40/2004 on ART outcomes, some authors demonstrating a negative impact of the Law in relation to specific etiologies of infertility, other authors showing opposite conclusions.

STUDY DESIGN, SIZE, DURATION

Retrospective clinical study of 3808 patients treated prior to the enactment of the Law, September 1996–March 2004 (Group I) and 6898 treated during the Law, March 2004–May 2009 (Group II).

PARTICIPANTS/MATERIALS, SETTING, METHODS

A total of 10 706 ART cycles were analysed, 3808 performed before and 6898 after the application of the Law. An intention-to-treat statistical analysis was performed to detect pregnancy and delivery rates (pregnancies ≥24 weeks) per started cycle. A P value of <0.05 was considered statistically significant. We analysed different outcomes: differences in fertilization, pregnancy and delivery rate, multiple pregnancies and miscarriage rates between the two time periods.

MAIN RESULTS AND THE ROLE OF CHANCE

The delivery rate for started cycle was 20% before and 16.0% after the introduction of the Law representing a 25% reduction (P < 0.001). The multivariate analysis, corrected by female age of >38 years, duration of infertility, basal FSH level and number of retrieved oocytes, showed a 16% lower delivery rate (odds ratio: 0.84; confidence interval: 0.75–0.94). This statistical approach removed the risk that the observed effects were due to chance and confirmed unequivocally that the Law was an independent factor responsible for the reduced likelihood of a successful outcome.

LIMITATIONS, REASONS FOR CAUTION

This is a retrospective study. A prospective randomized study, with patients treated in the same time period and randomized to restrictions or not, would have minimized potential limitations due to differences in years of treatments.

WIDER IMPLICATIONS OF THE FINDINGS

Our findings based on the analysis of such a large number of cycles proved clearly and unequivocally that imposing restrictions on the practice of ART penalized patients. These data represent a relevant clinical contribution for countries still debating the enactment of restrictive limitations of ART.

STUDY FUNDING/COMPETING INTEREST

This investigation has been supported by a finalized grant from Lombardy County, Italy (DGR 7255, 3 July 2008).

Source:
http://humrep.oxfordjournals.org/cgi/content/short/28/2/343?rss=1

STUDY QUESTION

How do families with children conceived using donor sperm operate as the children grow up?

SUMMARY ANSWER

Families with children aged 5–13 years conceived through anonymous donor sperm function well, when compared with other family types with children of the same developmental stage.

WHAT IS KNOWN ALREADY

Previous studies on family relationships after donor sperm conception have been reassuring. However, these studies have suffered from methodological limitations due to small sample sizes, respondent biases and absence of appropriate controls.

STUDY DESIGN, SIZE, DURATION

This study was an observational study comparing 79 ‘donor insemination’ (DI) families with 987 ‘couple’ families, 364 ‘single mother’ and 112 ‘step-father’ families as part of the Australian Institute of Family Studies Children and Family Life (CFL) study. CFL involved the collection of data on family functioning and child wellbeing from all resident parents through a Family and Child Questionnaire for the ‘primary’ parent (FACQ-P1) and a Family Relationship Questionnaire (FRQ-P2) for the ‘other’ parent.

PARTICIPANTS/MATERIALS, SETTING, METHODS

All questionnaires were coded with the identity known only to the researchers. The outcomes studied included parent psychological adjustment, family functioning, couple relationship, parenting and parent–child relationship. Family types were compared, separately for mothers' and fathers' reports. The results presented are the estimated means for each family type based on the final model for each outcome: post hoc comparisons between family types are reported with 95% confidence limits.

MAIN RESULTS AND THE ROLE OF CHANCE

With all of the outcomes considered, there was not one result where the DI families showed poorer functioning on average than the comparison groups.

LIMITATIONS, REASON FOR CAUTION

The final sample size of DI families is 79 with an excellent response rate of nearly 80%. However, there remains some scope for response bias.

WIDER IMPLICATIONS OF THE FINDINGS

This study further reassures us that families conceived with anonymous donor sperm do not function any differently from other family types.

STUDY FUNDING/COMPETING INTERESTS

The study was partly funded by a research grant from the Fertility Society of Australia, and the profits from a Serono Symposium on Polycystic Ovaries. There are no competing interests.

Source:
http://humrep.oxfordjournals.org/cgi/content/short/28/2/375?rss=1

STUDY QUESTION

How good is fertility knowledge and what are treatment beliefs in an international sample of men and women currently trying to conceive?

SUMMARY ANSWER

The study population had a modest level of fertility knowledge and held positive and negative views of treatment.

WHAT IS KNOWN ALREADY

Few studies have examined general fertility treatment attitudes but studies of specific interventions show that attitudes are related to characteristics of the patient, doctor and context. Further, research shows that fertility knowledge is poor. However, the majority of these studies have examined the prevalence of infertility, the optimal fertile period and/or age-related infertility in women, in university students and/or people from high-resource countries making it difficult to generalize findings.

STUDY DESIGN, SIZE, DURATION

A cross-sectional sample completed the International Fertility Decision-making Study (IFDMS) over a 9-month period, online or via social research panels and in fertility clinics.

PARTICIPANTS/MATERIALS, SETTING, METHODS

Participants were 10 045 people (8355 women, 1690 men) who were on average 31.8 years old, had been trying to conceive for 2.8 years with 53.9% university educated. From a total of 79 countries, sample size was >100 in 18 countries. All 79 countries were assigned to either a very high Human Development Index (VH HDI) or a not very high HDI (NVH HDI). The IFDMS was a 45-min, 64-item English survey translated into 12 languages. The inclusion criteria were the age between 18 and 50 years and currently trying to conceive for at least 6 months. Fertility knowledge was assessed using a 13-item correct/incorrect scale concerned with risk factors, misconceptions and basic fertility facts (range: 0–100% correct). Treatment beliefs were assessed with positive and negative statements about fertility treatment rated on a five-point agree/disagree response scale.

MAIN RESULTS AND THE ROLE OF CHANCE

Average correct score for Fertility Knowledge was 56.9%, with greater knowledge significantly related to female gender, university education, paid employment, VH HDI and prior medical consultation for infertility (all P < 0.001). The mean agreement scores for treatment beliefs showed that agreement for positive items (safety, efficacy) was correlated with agreement for negative items (short/long-term physical/emotional effects) (P > 0.001). People who had given birth/fathered a child, been trying to conceive for less than 12 months, who had never consulted for a fertility problem and who lived in a country with an NVH HDI agreed less with negative beliefs. HDI, duration of trying to conceive and help-seeking were also correlates of higher positive beliefs, alongside younger age, living in an urban area and having stepchildren. Greater fertility knowledge was associated with stronger agreement on negative treatment beliefs items (P < 0.001) but was unrelated to positive treatment beliefs items.

LIMITATIONS, REASONS FOR CAUTION

There was volunteer bias insofar as more women, people of higher education and people with fertility problems (i.e. met criteria for infertility, had consulted a medical doctor, had conceived with fertility treatment) participated and this was true in VH and NVH HDI countries. The bias may mean that people in this sample had better fertility knowledge and less favourable treatment beliefs than is the case in the general population.

WIDER IMPLICATIONS OF THE FINDINGS

Educational interventions should be directed at improving knowledge of fertility health. Future prospective research should be aimed at investigating how fertility knowledge and treatment beliefs affect childbearing and help-seeking decision-making.

STUDY FUNDING/COMPETING INTEREST(S)

Merck-Serono S. A. Geneva-Switzerland (an affiliate of Merck KGaA Darmstadt, Germany) and the Economic and Social Research Council (ESRC, UK) funded this project (RES-355-25-0038, ‘Fertility Pathways Network’). L.B. is funded by a postdoctoral fellowship from the Medical Research Council (MRC) and the ESRC (PTA-037-27-0192). I.T. is an employee of Merck-Serono S. A. Geneva-Switzerland (an affiliate of Merck KGaA Darmstadt, Germany).

Source:
http://humrep.oxfordjournals.org/cgi/content/short/28/2/385?rss=1