Conversion of in Vitro Fertilization Cycles to Intrauterine Inseminations in Patients With a Poor Ovarian Response to Stimulation
ConFIRM
1 other identifier
interventional
462
2 countries
32
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2017
CompletedFirst Posted
Study publicly available on registry
December 5, 2017
CompletedStudy Start
First participant enrolled
January 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2024
CompletedJune 18, 2024
June 1, 2024
4.9 years
November 24, 2017
June 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
IVF / IVF-ICSI
OTHERIn Vitro Fertilization / In Vitro Fertilization - Intracytoplasmic Sperm Injection (ICSI)
IUI
OTHERIntrauterine insemination
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Victor Pauchet Clinic
Amiens, France
UH Angers
Angers, 49000, France
UH Besançon
Besançon, France
Jean Verdier Hospital, APHP
Bondy, France
Polyclinique Jean Villar
Bruges, 33520, France
UH Caen
Caen, 14000, France
Clinique Léonard de Vinci
Chambray-lès-Tours, 37170, France
Cholet Hospital
Cholet, France
Antoine Béclère Hospital AP-HP
Clamart, 92140, France
Sud Francilien Hospital
Corbeil-Essonnes, France
IHC Créteil
Créteil, 94000, France
UH Grenoble
Grenoble, 38000, France
Tertre Rouge Clinic
Le Mans, France
UH Lille
Lille, France
Lorient Hospital
Lorient, 561000, France
UH La conception AP-HM
Marseille, 13005, France
Clinique Jules Verne
Nantes, 44000, France
UH Nantes
Nantes, 44000, France
Clinique Pierre Cherest
Neuilly-sur-Seine, 92200, 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, 35000, France
UH Rennes
Rennes, 35000, France
UH Rouen
Rouen, France
Polyclinique de L'Atlantique
Saint-Herblain, 44800, France
UH Strasbourg
Strasbourg, 67000, France
UH Toulouse
Toulouse, France
UHR Tours
Tours, 37000, France
UH Pointe-à-Pitre
Pointe-à-Pitre, Guadeloupe/France, 97110, Guadeloupe
Related Publications (1)
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.
PMID: 30333054DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pierre-Emmanuel BOUET, MD
University Hospital of Angers
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2017
First Posted
December 5, 2017
Study Start
January 10, 2018
Primary Completion
November 25, 2022
Study Completion
March 14, 2024
Last Updated
June 18, 2024
Record last verified: 2024-06