Conversion of in Vitro Fertilization Cycles to Intrauterine Inseminations in Patients With a Poor Ovarian Response to Stimulation (ConFIRM)
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|ClinicalTrials.gov Identifier: NCT03362489|
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : April 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Procedure: IVF / IVF-ICSI Procedure: IUI||Not Applicable|
In 5 to 10% of in vitro fertilization (IVF) cycles, a poor response to ovarian stimulation (defined as less than 4 mature follicles) is noted, even though high doses of exogenous gonadotropins are used. To date, there is no consensus on the ideal management strategy in poor responders. There are three therapeutic options available nowadays:
- Oocyte retrieval is performed and the IVF cycle continued, despite the low number of mature follicles.
- Conversion of the IVF cycle to an intrauterine insemination (IUI), on the condition of having at least one patent fallopian tube and good semen parameters.
- Cancelation of the IVF cycle. In everyday practice, it is difficult for the physician to cancel the IVF cycle in the presence of 2, 3 or 4 mature follicles, especially following a lengthy stimulation.
If live birth rates were comparable between IUI and IVF, conversion to IUI would be the better option for poor responders, since it would avoid an invasive procedure (oocyte retrieval) and the associated risk of complications, and is associated with at a lower cost.
To our knowledge, no prospective randomized controlled trial comparing IVF to conversion to IUI in poor responders has been published to date. The studies published so far have been retrospective and observational, and had several methodological flaws.
Therefore, we aimed to analyze whether conversion of IVF cycles to IUI in poor responders would result in the same live birth rates as oocyte retrievals followed by embryo transfers.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||940 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Conversion of in Vitro Fertilization Cycles to Intrauterine Inseminations in Patients With a Poor Ovarian Response to Stimulation|
|Actual Study Start Date :||January 10, 2018|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
IVF / IVF-ICSI
In Vitro Fertilization / In Vitro Fertilization - Intracytoplasmic Sperm Injection (ICSI)
Procedure: IVF / IVF-ICSI
In the "IVF" arm, oocyte retrieval is performed 36 hours after the HCG injection, in the operating room, under transvaginal ultrasound guidance, under local or general anesthesia. The procedure lasts about 20 minutes and the patients are discharged on the same day. The oocytes retrieved from the follicles are transported immediately to the lab for fertilization with the partner's sperm. Fertilization is done either via conventional IVF, or via ICSI, depending on the indication. Embryos are later transferred into the uterus on day 3 or day 5, under ultrasound guidance, in the outpatient department.
In the "conversion to IUI" arm, IUI is performed 24 to 36 hours after ovulation trigger. The partner provides the sperm on site on the morning of the insemination, which is performed in the outpatient department.
- The main criterion is the live birth rate [ Time Frame: 12 months ]Defined as the birth of a living infant after 22 weeks gestational age (GA), or weighing ≥ 500 g.
- Biochemical pregnancy rate [ Time Frame: 5 Weeks ]Defined as serum HCG levels >10 IU/L, 14 days after the IUI or the embryo transfer, followed by a rapid decrease until being undetectable.
- Clinical pregnancy rate [ Time Frame: 6-7 Weeks ]Defined as fetal cardiac activity at 6-7 weeks GA
- Spontaneous pregnancy loss (PL) rate [ Time Frame: 12 Weeks ]Including early and late pregnancy losses
- Multiple pregnancy rate [ Time Frame: 7-8 Weeks ]Defined as more than two embryos visualized on ultrasound at 7 weeks GA.
- Term at delivery [ Time Frame: 12 Months ]Term at delivery in Gestational age (GA)
- Neonatal complications [ Time Frame: 12 Months ]Neonatal complications
- Neonatal survival [ Time Frame: 12 Months ]Neonatal survival
- All outcome measure will be further analyzed according to the number of follicles on trigger day (2, 3 or 4) and patients' age (<40 years vs. ≥40 years) [ Time Frame: 12 Months ]Assess the impact of conversion to IUI, compared to IVF, on overall outcomes in in women with a poor ovarian response to stimulation, according to the number of follicles on trigger day (2, 3 or 4) and patients' age (<40 years vs. ≥40 years)
- All outcome measures will be further analyzed in the subgroup of women considered poor responders according to the Bologna criteria [ Time Frame: 12 Months ]Assess the clinical efficiency of conversion to IUI, compared to IVF, in women considered "poor ovarian responders" according to the Bologna criteria
- The rate of IVF cycles with empty follicle syndrome and no embryo transfers. [ Time Frame: 1 Week ]Analyze the rate of IVF cycles with empty follicle syndrome and no embryo transfers
- Cumulative clinical pregnancy and live birth rates in the IVF group, thus taking into account fresh and frozen embryos transferred in subsequent cycles [ Time Frame: 12 Months ]Assess the impact of conversion to IUI, compared to IVF, on the cumulative clinical pregnancy and live birth rates - taking into account frozen embryo transfers in IVF - in women with a poor ovarian response to stimulation
- Cost-efficiency analysis at 12 months [ Time Frame: 12 Months ]Compare the cost-efficiency of both strategies at 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362489
|Contact: Pierre-Emmanuel BOUET, MD||+33 (0)241354213||PierreEmmanuel.Bouet@chu-angers.fr|