Conversion of in Vitro Fertilization Cycles to Intrauterine Inseminations in Patients With a Poor Ovarian Response to Stimulation

University Hospital, Angers462 enrolled

Overview

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

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: 1. Oocyte retrieval is performed and the IVF cycle continued, despite the low number of mature follicles. 2. 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. 3. 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

462

Conditions

Infertility

Interventions

IVF / IVF-ICSIPROCEDURE

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.

IUIPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 43 Years

Medical Language ↔ Plain English

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

Locations (32)

Victor Pauchet Clinic

Amiens, France

Outcomes

Primary Outcomes

The main criterion is the live birth rate

Defined as the birth of a living infant after 22 weeks gestational age (GA), or weighing ≥ 500 g.

Time frame: 12 months

Secondary Outcomes

Biochemical pregnancy rate

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.

Time frame: 5 Weeks

Clinical pregnancy rate

Defined as fetal cardiac activity at 6-7 weeks GA

Time frame: 6-7 Weeks

Spontaneous pregnancy loss (PL) rate

Including early and late pregnancy losses

Time frame: 12 Weeks

Multiple pregnancy rate

Defined as more than two embryos visualized on ultrasound at 7 weeks GA.

Time frame: 7-8 Weeks

Term at delivery

Term at delivery in Gestational age (GA)

Time frame: 12 Months

Neonatal complications

Time frame: 12 Months

Neonatal survival

Time frame: 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)

Data from ClinicalTrials.gov

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