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

University Hospital, Angers

Status: Completed

Conditions: Infertility

Treatments: Procedure: IUI; Procedure: IVF / IVF-ICSI

Study type: Interventional

Funder types: Other

Identifiers

NCT03362489

2017-A00862-51

Details and patient eligibility

About

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

Full 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:

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.

Enrollment: 462 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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462 participants in 2 patient groups

IVF / IVF-ICSI

Other group

Description:

In Vitro Fertilization / In Vitro Fertilization - Intracytoplasmic Sperm Injection (ICSI)

Treatment:

Procedure: IVF / IVF-ICSI

IUI

Other group

Description:

Intrauterine insemination

Treatment:

Procedure: IUI