Does the effectiveness of IUI in couples with unexplained subfertility depend on their prognosis of natural conception? A replication of the H2Oil study.
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ABSTRACT:
SUBMITTER: van Eekelen R
PROVIDER: S-EPMC7875174 | biostudies-literature | 2020
REPOSITORIES: biostudies-literature
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Does the effectiveness of IUI in couples with unexplained subfertility depend on their prognosis of natural conception? A replication of the H2Oil study.
van Eekelen R R Rosielle K K van Welie N N Dreyer K K van Wely M M Mol B W BW Eijkemans M J MJ Mijatovic V V van Geloven N N
Human reproduction open 20201117 4
<h4>Study question</h4>Can we replicate the finding that the benefit of IUI-ovarian stimulation (IUI-OS) compared to expectant management for couples with unexplained subfertility depends on the prognosis of natural conception?<h4>Summary answer</h4>The estimated benefit of IUI-OS did not depend on the prognosis of natural conception but did depend on when treatment was started after diagnosis, with starting IUI-OS later yielding a larger absolute and relative benefit of treatment.<h4>What is kn ...[more]
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Project description: Not available
| S-EPMC8366296 | biostudies-literature
Project description:BackgroundIn unexplained and mild male factor subfertility, both intrauterine insemination (IUI) and in-vitro fertilisation (IVF) are indicated as first line treatments. Because the success rate of IUI is low, many couples failing IUI subsequently require IVF treatment. In practice, it is therefore important to examine the comparative outcomes (live birth-producing pregnancy), costs, and cost-effectiveness of primary offer of IVF, compared with primary offer of IUI followed by IVF for couples failing IUI.MethodsMathematical modelling was used to estimate comparative clinical and cost effectiveness of either primary offer of one full IVF cycle (including frozen cycles when applicable) or "IUI + IVF" (defined as primary IUI followed by IVF for IUI failures) to a hypothetical cohort of subfertile couples who are eligible for both treatment strategies. Data used in calculations were derived from the published peer-reviewed literature as well as activity data of local infertility units.ResultsCost-effectiveness ratios for IVF, "unstimulated-IUI (U-IUI) + IVF", and "stimulated IUI (S-IUI) + IVF" were 12,600 pounds sterling, 13,100 pound sterling and 15,100 pound sterling per live birth-producing pregnancy respectively. For a hypothetical cohort of 100 couples with unexplained or mild male factor subfertility, compared with primary offer of IVF, 6 cycles of "U-IUI + IVF" or of "S-IUI + IVF" would cost an additional 174,200 pounds sterling and 438,000 pounds sterling, representing an opportunity cost of 54 and 136 additional IVF cycles and 14 to 35 live birth-producing pregnancies respectively.ConclusionFor couples with unexplained and mild male factor subfertility, primary offer of a full IVF cycle is less costly and more cost-effective than providing IUI (of any modality) followed by IVF.
| S-EPMC1543624 | biostudies-literature
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| S-EPMC9712943 | biostudies-literature
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| S-EPMC6946937 | biostudies-literature
Project description:BackgroundSubfertility among couples affected by HIV has an impact on the well-being of couples who desire to have children and may prolong HIV exposure. Subfertility in the antiretroviral therapy era and its determinants have not yet been well characterized.ObjectiveThe objective of the study was to investigate the burden and determinants of subfertility among HIV-affected couples seeking safer conception services in South Africa.Study designNonpregnant women and male partners in HIV seroconcordant or HIV discordant relationships desiring a child were enrolled in the Sakh'umndeni safer conception cohort at Witkoppen Clinic in Johannesburg between July 2013 and April 2017. Clients were followed up prospectively through pregnancy (if they conceived) or until 6 months of attempted conception, after which they were referred for infertility services. Subfertility was defined as not having conceived within 6 months of attempted conception. Robust Poisson regression was used to assess the association between baseline characteristics and subfertility outcomes; inverse probability weighting was used to account for missing data from women lost to safer conception care before 6 months of attempted conception.ResultsAmong 334 couples enrolled, 65% experienced subfertility (inverse probability weighting weighted, 95% confidence interval, 0.59-0.73), of which 33% were primary subfertility and 67% secondary subfertility. Compared with HIV-negative women, HIV-positive women not on antiretroviral therapy had a 2-fold increased risk of subfertility (weighted and adjusted risk ratio, 2.00; 95% confidence interval, 1.19-3.34). Infertility risk was attenuated in women on antiretroviral therapy but remained elevated, even after ≥2 years on antiretroviral therapy (weighted and adjusted risk ratio, 1.63; 95% confidence interval, 0.98-2.69). Other factors associated with subfertility were female age (weighted and adjusted risk ratio, 1.03, 95% confidence interval, 1.01-1.05 per year), male HIV-positive status (weighted and adjusted risk ratio, 1.31; 95% confidence interval, 1.02-1.68), male smoking (weighted and adjusted risk ratio, 1.29; 95% confidence interval, 1.05-1.60), and trying to conceive for ≥1 year (weighted and adjusted risk ratio, 1.38; 95% confidence interval, 1.13-1.68).ConclusionTwo in 3 HIV-affected couples experienced subfertility. HIV-positive women were at increased risk of subfertility, even when on antiretroviral therapy. Both male and female HIV status were associated with subfertility. Subfertility is an underrecognized reproductive health problem in resource-limited settings and may contribute to prolonged HIV exposure and transmission within couples. Low-cost approaches for screening and treating subfertility in this population are needed.
| S-EPMC6592765 | biostudies-literature
Project description:BackgroundMultiple pregnancies are high risk pregnancies with higher chances of maternal and neonatal mortality and morbidity. In the past decades the number of multiple pregnancies has increased. This trend is partly due to the fact that women start family planning at an increased age, but also due to the increased use of ART.Couples with unexplained or mild male subfertility generally receive intrauterine insemination IUI with controlled hormonal stimulation (IUI COH). The cumulative pregnancy rate is 40%, with a 10% multiple pregnancy rate.This study aims to reveal whether alternative treatments such as IVF elective Single Embryo Transfer (IVF e SET) or Modified Natural Cycle IVF (MNC IVF) can reduce the number of multiple pregnancy rates, but uphold similar pregnancy rates as IUI COH in couples with mild male or unexplained subfertility. Secondly, the aim is to perform a cost effective analyses and assess treatment preference of these couples.Methods/designWe plan a multicentre randomised controlled clinical trial in the Netherlands comparing six cycles of intra-uterine insemination with controlled ovarian hyperstimulation or six cycles of Modified Natural Cycle (MNC) IVF or three cycles with IVF-elective Single Embryo Transfer (eSET) plus cryo-cycles within a time frame of 12 months.Couples with unexplained subfertility or mild male subfertility and a poor prognosis for treatment independent pregnancy will be included. Women with anovulatory cycles, severe endometriosis, double sided tubal pathology or serious endocrine illness will be excluded.Our primary outcome is the birth of a healthy singleton. Secondary outcomes are multiple pregnancy, treatment costs, and patient experiences in each treatment arm. The analysis will be performed according tot the intention to treat principle. We will test for non-inferiority of the three arms with respect to live birth. As we accept a 12.5% loss in pregnancy rate in one of the two IVF arms to prevent multiple pregnancies, we need 200 couples per arm (600 couples in total).DiscussionDetermining the safest and most cost-effective treatment will ensure optimal chances of pregnancy for subfertile couples with substantially diminished perinatal and maternal complications. Should patients find the most cost-effective treatment acceptable or even preferable, this could imply the need for a world wide shift in the primary treatment.Trial registrationCurrent Controlled Trials ISRCTN 52843371.
| S-EPMC2804565 | biostudies-literature
Project description: Not available
| S-EPMC7059962 | biostudies-literature
Project description: Not available
| S-EPMC7550266 | biostudies-literature
Project description:Study questionWhich couples with unexplained subfertility can expect increased chances of ongoing pregnancy with IVF compared to expectant management?Summary answerFor couples in which the woman is under 40 years of age, IVF is associated with higher chances of conception than expectant management.What is known alreadyThe clinical indications for IVF have expanded over time from bilateral tubal blockage to include unexplained subfertility in which there is no identifiable barrier to conception. Yet, there is little evidence from randomized controlled trials that IVF is effective in these couples.Study design, size, durationWe compared outcomes in British couples with unexplained subfertility undergoing IVF (n = 40 921) from registry data to couples with the same type of subfertility on expectant management. Those couples on expectant management (defined as no intervention aside from the advice to have intercourse) comprised a prospective nation-wide Dutch cohort (n = 4875) and a retrospective regional cohort from Aberdeen, Scotland (n = 975). We excluded couples who had tried for <1 year to conceive and also those with anovulation, uni- or bilateral tubal occlusion, mild or severe endometriosis or male subfertility i.e. impaired semen quality according to World Health Organization criteria.Participants/materials, setting, methodsWe matched couples who received IVF and couples on expectant management based on their characteristics to control for confounding. We fitted a Cox proportional hazards model including patient characteristics, IVF treatment and their interactions to estimate the individualized chance of conception over 1 year-either following IVF or expectant management for all combinations of patient characteristics. The endpoint was conception leading to ongoing pregnancy, defined as a foetus reaching a gestational age of at least 12 weeks.Main results and the role of chanceThe adjusted 1-year chance of conception was 47.9% (95% CI: 45.0-50.9) after IVF and 26.1% (95% CI: 24.2-28.0) after expectant management. The absolute difference in the average adjusted 1-year chances of conception was 21.8% (95%CI: 18.3-25.3) in favour of IVF. The effectiveness of IVF was influenced by female age, duration of subfertility and previous pregnancy. IVF was effective in women under 40 years, but the 1-year chance of an IVF conception declined sharply in women over 34 years. In contrast, in woman over 40 years of age, IVF was less effective, with an absolute difference in chance compared to expectant management of 10% or lower. Regardless of female age, IVF was also less effective in couples with a short period of secondary subfertility (1 year) who had chances of natural conception of 30% or above.Limitations, reasons for cautionThe 1-year chances of conception were based on three cohorts with different sampling mechanisms. Despite adjustment for the three most important prognostic patient characteristics, namely female age, duration of subfertility and primary or secondary subfertility, our estimates might not be free from residual confounding.Wider implications of the findingsIVF should be used selectively based on judgements on gain compared to continuing expectant management for a given couple. Our results can be used by clinicians to counsel couples with unexplained subfertility, to inform their expectations and facilitate evidence-based, shared decision making.Study funding/competing interest(s)This work was supported by Tenovus Scotland [grant G17.04]. Travel for RvE was supported by the Amsterdam Reproduction & Development Research Group [grant V.000296]. SB reports acting as editor-in-chief of HROpen. Other authors have no conflicts.
| S-EPMC9185855 | biostudies-literature
Project description:Study questionWhat are the experiences and the support and sexual advice needs of subfertile couples continuing to attempt natural conception after the diagnostic fertility work-up?Summary answerExploration of the experiences of couples showed that couples would have appreciated fertility clinic staff embedding expectant management into the fertility clinic trajectory, supportive staff with female and male patient interactions and advice on common experiences of peers and on managing their lifestyle, distress and subfertility-related sexual challenges.What is known alreadyDutch and British professional guidelines advise newly diagnosed subfertile couples with a 'good prognosis' to continue to attempt natural conception and do not require fertility clinic staff to interact with patients. Fertility clinic staff and subfertile couples struggle to follow these guidelines as they feel an urgent need for action. Subfertile couples might benefit from sexual advice, as subfertility is negatively associated with sexual functioning, which is important for natural conception.Study design size durationTwelve one-time in-depth interviews (2015-2017) were conducted with 10 heterosexual couples and 2 women whose partners did not participate, then the interviews were subjected to inductive content analysis, reaching inductive thematic saturation.Participants/materials setting methodsThe 22 interviewees had experienced 3-18 months of expectant management after their diagnostic fertility work-up in a Belgian or a Dutch tertiary fertility clinic. The face-to-face in-depth interviews explored positive and negative experiences and unmet needs. The transcribed interviews were subjected to inductive content analysis, by two researchers discussing initial disagreements.Main results and the role of chanceCouples would appreciate fertility clinic staff embedding expectant management in the fertility clinic trajectory, by starting off with reassuring couples that their very thorough diagnostic fertility work-up demonstrated their good chance of natural conception, and by involving couples in deciding on the duration of expectant management and by planning the follow-up appointment after expectant management up front. Couples had encountered sexual challenges during expectant management and had an interest in sexual advice, focused on increasing pleasure and partner bonding and preventing the rise of dysfunctions. The couples agreed that a (secured) website with evidence-based, non-patronizing text and mixed media would be an appropriate format for a novel support programme. Couples were keen for interactions with fertility clinic staff which addressed both partners of subfertile couples. Couples also valued advice on managing their lifestyle and distress and would have liked information on the experiences of their peers.Limitations reasons for cautionRecall bias is plausible given the retrospective nature of this study. This explorative interview study was not designed for examining country or gender differences in experiences and needs but it did generate new findings on inter-country differences.Wider implications of the findingsRather than simply advising expectant management, fertility clinics are encouraged to offer couples who continue to attempt natural conception after their diagnostic fertility work-up, supportive patient-staff interactions with advice on common experiences of peers and on managing their lifestyle, distress and sexual challenges related to subfertility.Study funding/competing interestsFunded by Flanders Research Foundation and the University of Amsterdam. There are no competing interests.Trial registration numberN/A.
| S-EPMC9479888 | biostudies-literature