Intrauterine insemination at 42 hours versus 36 hours after the hCG ovulation trigger

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized superiority trial will compare timing of intrauterine insemination performed at 42–43 hours versus 36–37 hours after hCG ovulation trigger in people undergoing gonadotropin-stimulated cycles with a GnRH antagonist. Participants will receive standard ovarian stimulation, luteal phase progestin support, and insemination using partner or donor sperm according to local procedures, with only the timing of IUI differing between groups. The primary outcome is live birth rate per cycle, and centers across France will follow participants through pregnancy outcome. The trial will also record sperm origin and other cycle variables to explore whether timing effects differ by sperm source.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Single unmarried woman or heterosexual or homosexual couple in which the woman wishing to carry the pregnancy is aged 18 to 43 and the spouse is aged 18 to 60 at the time of inclusion
* 2 permeable tubes for the woman receiving the insemination
* Spouse's sperm (Number of inseminable sperm ≥ 1 million in prior survival migration test) or sperm donation
* 1st or 2nd intrauterine insemination for this child project
* Ovarian stimulation by gonadotropin with GnRH antagonist (introduced on a fixed day or according to the follicular size criterion of the center)
* Luteal phase support with a progestin until at least the pregnancy test
* Affiliation or beneficiary of a social security scheme or equivalent for both partners of the couple if applicable
* Free and informed consent signed by the unmarried woman or both members of the couple
* Couples and unmarried women meeting the conditions for access to PMA according to the French bioethics law

Exclusion Criteria:

* Endometriosis stage III or IV
* History of ectopic pregnancy
* ≥ 3 spontaneous miscarriages
* Single woman or couple where one of the two partners (or both) is (are) under the protection of justice, under guardianship or under curatorship
* Single woman or couple who have already participated in the study once
* Single woman or couple participating in another interventional clinical study

Where it's running

• CHU Toulouse
  Toulouse, France Recruiting
• CHU Bordeaux
  Bordeaux, France Not yet recruiting
• CHU La Réunion
  La Réunion, France Not yet recruiting
• CHU Poitiers
  Poitiers, France Not yet recruiting

Study contacts

• Study coordinator: Jessika MOREAU, MD
• Email: moreau.je@chu-toulouse.fr
• Phone: 567771017

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.