Conversion of in Vitro Fertilization Cycles to Intrauterine Inseminations in Patients With a Poor Ovarian Response to Stimulation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 462
- Locations
- 50
- Primary Endpoint
- The main criterion is the live birth rate
Study Overview
Brief Summary
The purpose of this study is to compare the efficiency of conversion to IUI and IVF in patients with a poor ovarian response to stimulation
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 43 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who accepted being included and signed the consent forms.
- •Age ≥18 years et <43 years.
- •IVF cycle with and without Intra Cytoplasmic Sperm Injection (ICSI):
- •"Conventional" Agonist (long and short) or antagonist protocol, using urinary or recombinant gonadotropins.
- •Having only 2, 3 or 4 mature follicles (≥14 mm) on ovulation trigger day.
Exclusion Criteria
- •Confirmed bilateral tubal occlusion
- •Non-French speaking patients
- •Partners with severe oligoasthenoteratospermia (OATS) (<5 millions motile spermatozoa in the ejaculate)
- •Suboptimal stimulation protocols:
- •Protocols ≤ 150 IU of daily gonadotropins
- •Mild stimulation protocols
- •Natural and modified natural cycle protocols
- •Women under legal guardianship
- •Women with no health or social security coverage
- •Women participating in other interventional trials
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Biochemical pregnancy rate(5 Weeks)
- Clinical pregnancy rate(6-7 Weeks)
- Spontaneous pregnancy loss (PL) rate(12 Weeks)
- Multiple pregnancy rate(7-8 Weeks)
- Term at delivery(12 Months)
- Neonatal complications(12 Months)
- Neonatal survival(12 Months)
- 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)(12 Months)
- All outcome measures will be further analyzed in the subgroup of women considered poor responders according to the Bologna criteria(12 Months)
- The rate of IVF cycles with empty follicle syndrome and no embryo transfers.(1 Week)
- Cumulative clinical pregnancy and live birth rates in the IVF group, thus taking into account fresh and frozen embryos transferred in subsequent cycles(12 Months)
- Cost-efficiency analysis at 12 months(12 Months)