STUDY QUESTION

What is the relationship between the rate of elective single-embryo transfer (eSET) and couples' exposure to different elements of a multifaceted implementation strategy?

SUMMARY ANSWER

Additional elements in a multifaceted implementation strategy do not result in an increased eSET rate.

WHAT IS KNOWN ALREADY

A multifaceted eSET implementation strategy with four different elements is effective in increasing the eSET rate by 11%. It is unclear whether every strategy element contributes equally to the strategy's effectiveness.

STUDY DESIGN AND SIZE

An observational study was performed among 222 subfertile couples included in a previously performed randomized controlled trial.

PARTICIPANTS, SETTINGS AND METHODS

Of the 222 subfertile couples included, 109 couples received the implementation strategy and 113 couples received standard IVF care. A multivariate regression analysis assessed the effectiveness of four different strategy elements on the decision about the number embryos to be transferred. Questionnaires evaluated the experiences of couples with the different elements.

MAIN RESULTS AND ROLE OF CHANCE

Of the couples who received the implementation strategy, almost 50% (52/109) were exposed to all the four elements of the strategy. The remaining 57 couples who received two or three elements of the strategy could be divided into two further classes of exposure. Our analysis demonstrated that additional elements do not result in an increased eSET rate. In addition to the physician's advice, couples rated a decision aid and a counselling session as more important for their decision to transfer one or two embryos, compared with a phone call and a reimbursement offer (P < 0.001).

LIMITATIONS AND REASONS FOR CAUTION

The differences in eSET rate between exposure groups failed to reach significance, probably because of the small numbers of couples in each exposure group.

WIDER IMPLICATIONS OF THE FINDINGS

Adding more elements to an implementation strategy does not always result in an increased effectiveness, which is in concordance with recent literature. This in-depth evaluation of a multifaceted intervention strategy could therefore help to modify strategies, by making them more effective and less expensive.

STUDY FUNDING/COMPETING INTERESTS

There are no funding sources or competing interests to be declared.

Source:
http://humrep.oxfordjournals.org/cgi/content/short/28/2/336?rss=1

Recommendation and review posted by G. Smith

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

Recommendation and review posted by G. Smith

STUDY QUESTION

What do older women understand of the relationship between age and fertility prior and subsequent to delivering their first child?

SUMMARY ANSWER

Women who were first-time parents over the age of 40 did not accurately perceive the relationship between age and fertility prior to conceiving with IVF.

WHAT IS KNOWN ALREADY

While increases in women's age at their first birth have been most pronounced in relatively older women, the rapidity of fertility decline is not appreciated by most non-infertility specialist physicians, the general public or men and women who are delaying childbearing.

STUDY DESIGN, SIZE AND DURATION

Qualitative retrospective interviews were conducted from 2009 to 2011 with 61 self-selected women who were patients in one of two fertility clinics in the USA.

PARTICIPANTS/MATERIALS, SETTING, METHODS

All participants had delivered their first child following IVF when the woman was 40 years or older. The data include women's responses to the semi-structured and open-ended interview questions ‘What information did you have about fertility and age before you started trying to get pregnant?’ and ‘What did you learn once you proceeded with fertility treatment?’

MAIN RESULTS AND THE ROLE OF CHANCE

Of the women, 30% expected their fertility to decline gradually until menopause at around 50 years and 31% reported that they expected to get pregnant without difficulty at the age of 40. Reasons for a mistaken belief in robust fertility included recollections of persistent and ongoing messaging about pregnancy prevention starting in adolescence (23%), healthy lifestyle and family history of fertility (26%), and incorrect information from friends, physicians or misleading media reports of pregnancies in older celebrity women (28%). Participants had not anticipated the possibility that they would need IVF to conceive with 44% reporting being ‘shocked’ and ‘alarmed’ to discover that their understanding of the rapidity of age-related reproductive decline was inaccurate’. In retrospect, their belated recognition of the effect of age on fertility led 72% of the women to state that they felt ‘lucky’ or had ‘beaten the odds’ in successfully conceiving after IVF. Of the women, 28% advocated better fertility education earlier in life and 23% indicated that with more information about declining fertility, they might have attempted conception at an earlier age. Yet 46% of women acknowledged that even if they had possessed better information, their life circumstances would not have permitted them to begin childbearing earlier.

LIMITATIONS AND REASONS FOR CAUTION

Both the self-selected nature of recruitment and the retrospective design can result in biases due to memory limitations or participant assimilation and/or contrast of past events with current moods. The cohort did not reflect broad homogeneity in that the participants were much more likely to be highly educated, Caucasian and better able to pay for treatment than national population norms. As attitudes of older women who were unsuccessful after attempting IVF in their late 30s or early 40s are not represented, it is possible (if not likely) that the recollections of women who did not conceive after IVF would have been more strongly influenced by feelings of regret or efforts to deflect blame for their inability to conceive.

WIDER IMPLICATIONS OF THE FINDINGS

While the failure to appreciate the true biological relationship between aging and fertility may be common and may reflect inaccessibility or misinterpretation of information, it is not sufficient to explain the decades-long socio-demographic phenomenon of delayed childbearing.

STUDY FUNDING/COMPETING INTEREST(S)

This study was funded by the US National Institute of Child and Human Development (NICHD, RO1-HD056202).

Source:
http://humrep.oxfordjournals.org/cgi/content/short/28/2/350?rss=1

Recommendation and review posted by G. Smith

STUDY QUESTION

Is optimal adherence to guideline recommendations in intrauterine insemination (IUI) care cost-effective from a societal perspective when compared with suboptimal adherence to guideline recommendations?

SUMMARY ANSWER

Optimal guideline adherence in IUI care has substantial economic benefits when compared with suboptimal guideline adherence.

WHAT IS KNOWN ALREADY

Fertility guidelines are tools to help health-care professionals, and patients make better decisions about clinically effective, safe and cost-effective care. Up to now, there has been limited published evidence about the association between guideline adherence and cost-effectiveness in fertility care.

STUDY DESIGN, SIZE, DURATION

In a retrospective cohort study involving medical record analysis and a patient survey (n = 415), interviews with staff members (n = 13) and a review of hospitals' financial department reports and literature, data were obtained about patient characteristics, process aspects and clinical outcomes of IUI care and resources consumed. In the cost-effectiveness analyses, restricted to four relevant guideline recommendations, the ongoing pregnancy rate per couple (effectiveness), the average medical and non-medical costs of IUI care, possible additional IVF treatment, pregnancy, delivery and period from birth up to 6 weeks after birth for both mother and offspring per couple (costs) and the incremental net monetary benefits were calculated to investigate if optimal guideline adherence is cost-effective from a societal perspective when compared with suboptimal guideline adherence.

PARTICIPANTS/MATERIALS, SETTING, METHODS

Seven hundred and sixty five of 1100 randomly selected infertile couples from the databases of the fertility laboratories of 10 Dutch hospitals, including 1 large university hospital providing tertiary care and 9 public hospitals providing secondary care, were willing to participate, but 350 couples were excluded because of ovulatory disorders or the use of donated spermatozoa (n = 184), still ongoing IUI treatment (n = 143) or no access to their medical records (n = 23). As a result, 415 infertile couples who started a total of 1803 IUI cycles were eligible for the cost-effectiveness analyses.

MAIN RESULTS AND THE ROLE OF CHANCE

Optimal adherence to the guideline recommendations about sperm quality, the total number of IUI cycles and dose of human chorionic gonadotrophin was cost-effective with an incremental net monetary benefit between 645 and over 7500 per couple, depending on the recommendation and assuming a willingness to pay 20 000 for an ongoing pregnancy.

LIMITATIONS, REASONS FOR CAUTION

Because not all recommendations applied to all 415 included couples, smaller groups were left for some of the cost-effectiveness analyses, and one integrated analysis with all recommendations within one model was impossible.

WIDER IMPLICATIONS OF THE FINDINGS

Optimal guideline adherence in IUI care has substantial economic benefits when compared with suboptimal guideline adherence. For Europe, where over 144 000 IUI cycles are initiated each year to treat ~32 000 infertile couples, this could mean a possible cost saving of at least 20 million euro yearly. Therefore, it is valuable to make an effort to improve guideline development and implementation.

STUDY FUNDING/COMPETING INTEREST(S)

This study was supported financially by the Netherlands Organisation for Health Research and Development, Grant No. 945-12-012, The Hague, The Netherlands. The funding source had no involvement in the study. The authors declare that they have no conflict of interest.

Source:
http://humrep.oxfordjournals.org/cgi/content/short/28/2/357?rss=1

Recommendation and review posted by G. Smith

STUDY QUESTION

Are the risks of hypoplastic left heart syndrome, transposition of great arteries, tetralogy of Fallot (TOF) and coarctation of the aorta increased in infants conceived by different assisted reproductive techniques (ARTs)?

STUDY ANSWER

ARTs, and particularly intracytoplasmic sperm injection (ICSI), are specifically associated with a higher risk of TOF.

WHAT IS ALREADY KNOWN

ARTs are associated with an increase in the overall risk of birth defects. The risk for congenital heart defects (CHDs) associated with ARTs has been evaluated as a whole but there is limited information on the risks for specific CHDs.

STUDY DESIGN, MATERIAL AND METHODS

We conducted a case–control study using population-based data from the Paris registry of congenital malformations for the period 1987–2009 and a cohort study of CHD (EPICARD) on 1583 cases of CHDs and 4104 malformed controls with no known associations with ARTs. ARTs included ovulation induction only, IVF and ICSI.

RESULTS

Exposure to ARTs was significantly higher for TOF than controls (6.6 versus 3.5%, P = 0.002); this was not the case for the other three CHDs. ARTs (all methods combined) were associated with a 2.4-fold higher odds of TOF after adjustment for maternal characteristics, paternal age and year of birth [adjusted odds ratios (OR): 2.4, 95% confidence interval (CI): 1.5–3.7] with the highest risk associated with ICSI (adjusted OR: 3.0, 95% CI: 1.0–8.9). No statistically significant associations were found for the other CHDs.

LIMITATIONS

Our study cannot disentangle to what extent the observed associations between the risk of TOF and ARTs are due to causal effects of ARTs and/or the underlying infertility problems of couples who conceive following ART.

IMPLICATIONS

The developmental basis of the specific association between the risk of TOF and ARTs need to be further investigated.

FUNDING

This work was supported by grants from the Agence de Biomédecine (Saint-Denis La Plaine, France) (to B.K.). The Paris Registry of Congenital Malformations received financial support from INSERM (Paris, France) and the Institut de Veille Sanitaire (Saint-Maurice, France). The EPICARD study was supported by three grants from the Ministry of Health (PHRC 2004, 2008 and 2011). Additional funding for the EPICARD study was provided by the AREMCAR Association (Association pour la Recherche et l'Etude des Maladies Cardiovasculaires).

COMPETING INTERESTS

None.

Source:
http://humrep.oxfordjournals.org/cgi/content/short/28/2/367?rss=1

Recommendation and review posted by G. Smith

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

Recommendation and review posted by G. Smith