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. 2018 Oct 17;19(1):565.
doi: 10.1186/s13063-018-2936-5.

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

Léa Delbos  1 , Elsa Parot-Schinkel  2 , Hady El Hachem  3 , Guillaume Legendre  4 , Philippe Descamps  4 , Lisa Boucret  4 , Véronique Ferré-L'Hotellier  4 , Pauline Jeanneteau  4 , Cécile Dreux  4 , Catherine Morinière  5 , Pascale May-Panloup  4 , Pierre-Emmanuel Bouet  4
Affiliations

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

Léa Delbos et al. Trials. .

Abstract

Background: To date, there is no consensus on the ideal management strategy of patients with poor ovarian response (POR) to controlled ovarian stimulation (COS) for in vitro fertilization (IVF). Currently, these patients are given the choice of: (1) canceling the cycle; (2) proceeding with COS regardless of the poor response, and performing the oocyte retrieval and transfer of embryos when available; or (3) conversion to an intrauterine insemination (IUI). When the decision to proceed with the COS cycle is taken, it is not clear whether IVF or conversion to IUI is the best choice. If live birth rates were comparable between the two strategies, conversion to IUI would be the better option for poor responders, since it is less invasive and is associated with a lower cost.

Methods: We designed a non-inferiority, multicentric, randomized controlled trial that will be conducted in 18 French Reproductive Medicine centers. We defined POR as the presence of only two or four mature follicles ≥ 14 mm on ovulation trigger day. Patients with POR will be randomized into two parallel arms: "IVF" and "conversion to IUI." Our main objective is to compare the efficiency of IVF and conversion to IUI in patients with POR to COS. The primary outcome is the live birth rate, defined as the birth of a living infant after 22 weeks' gestational age, or weighing ≥ 500 g. One of the secondary objectives is to compare the cost-efficiency of both strategies at 12 months. We will need to include 940 patients (470 in each arm), and the duration of the inclusion period is estimated to be 36 months.

Discussion: This is the first randomized controlled trial to compare the outcomes of IVF and embryo transfer to conversion to IUI in patients with POR to COS. If our study shows that conversion to IUI is non-inferior to IVF in terms of clinical efficiency and live birth rate, it would confirm IUI as a better alternative for patients, both individually (less invasive and more patient-friendly) and collectively (lower cost).

Trials registration: ClinicalTrials.gov, ID: NCT03362489 . Registered on January 10th, 2018.

Keywords: Conversion to IUI; IVF; Poor ovarian response.

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Conflict of interest statement

Ethics approval and consent to participate

The Ethics Committee of Lyon South-East II (registration number: 2017-23-2) has granted ethics approval for this study. In the event of additional studies performing subanalyses based on our database, all the investigators should keep the results confidential until these are publicly available, and they cannot publish any data related to the database without the approval of the principle investigator. During the inclusion visit, the investigator will thoroughly explain the study and hand the patient an information letter, written in an easily accessible language. The patient who wishes to be enrolled will sign the consent form, and will be randomized to one of the two groups.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1
Fig. 1
Flow chart. COS controlled ovarian stimulation, V visit, IUI intrauterine insemination, IVF in vitro fertilization
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure of ConFIRM study protocol
See this image and copyright information in PMC

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