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

NCT ID: NCT03362489

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 462 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2024-03-14

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:

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IVF / IVF-ICSI

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

Group Type: OTHER

IVF / IVF-ICSI

Intervention Type: PROCEDURE

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.

IUI

Intrauterine insemination

Group Type: OTHER

IUI

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

IUI

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre-Emmanuel BOUET, MD

Role: STUDY_DIRECTOR

University Hospital of Angers

Locations

Victor Pauchet Clinic

Amiens, , France

UH Angers

Angers, , France

UH Besançon

Besançon, , France

Jean Verdier Hospital, APHP

Bondy, , France

Polyclinique Jean Villar

Bruges, , France

UH Caen

Caen, , France

Clinique Léonard de Vinci

Chambray-lès-Tours, , France

Cholet Hospital

Cholet, , France

Antoine Béclère Hospital AP-HP

Clamart, , France

Sud Francilien Hospital

Corbeil-Essonnes, , France

IHC Créteil

Créteil, , France

UH Grenoble

Grenoble, , France

Tertre Rouge Clinic

Le Mans, , France

UH Lille

Lille, , France

Lorient Hospital

Lorient, , France

UH La conception AP-HM

Marseille, , France

Clinique Jules Verne

Nantes, , France

UH Nantes

Nantes, , France

Clinique Pierre Cherest

Neuilly-sur-Seine, , France

UH Nîmes

Nîmes, , France

Hospital of Orléans

Orléans, , France

Cochin Hospital, APHP

Paris, , France

Poissy Saint Germain en Laye Hospital

Poissy, , France

UH Potiers

Potiers, , France

Clinique Mutualiste de la Sagesse

Rennes, , France

UH Rennes

Rennes, , France

UH Rouen

Rouen, , France

Polyclinique de L'Atlantique

Saint-Herblain, , France

UH Strasbourg

Strasbourg, , France

UH Toulouse

Toulouse, , France

UHR Tours

Tours, , France

UH Pointe-à-Pitre

Pointe-à-Pitre, Guadeloupe/France, Guadeloupe

Countries

France; Guadeloupe

References

Delbos L, Parot-Schinkel E, El Hachem H, Legendre G, Descamps P, Boucret L, Ferre-L'Hotellier V, Jeanneteau P, Dreux C, Moriniere C, May-Panloup P, Bouet PE. ConFIRM trial - conversion of in vitro fertilization cycles to intrauterine inseminations in patients with a poor ovarian response to stimulation: a protocol for a multicentric, prospective randomized trial. Trials. 2018 Oct 17;19(1):565. doi: 10.1186/s13063-018-2936-5.

Reference Type: DERIVED

PMID: 30333054 (View on PubMed)

Other Identifiers

2017-A00862-51

Identifier Type: -

Identifier Source: org_study_id