RecruitingNot ApplicableNCT06804538

Interest of Sperm Insemination at 42 Hours Post hCG Compared to 36h in Intrauterine Insemination

Interest of Sperm Insemination at 42 Hours Post hCG Compared to 36h in Intrauterine Insemination : a Randomized Controlled Trial. SYNcIU

Sponsor

University Hospital, Toulouse

Enrollment

692 participants

Start Date

Sep 9, 2025

Study Type

INTERVENTIONAL

Conditions

Infertility Intrauterine Insemination (IUI)

Summary

Intrauterine insemination (IUI) is a common therapeutic option to treate infertility. Typically performed 36 hours post-hCG injection to trigger ovulation. However, research suggests delaying IUI to 42 hours post-hCG may improve egg quality and sperm synchronization for fertilization, leading to higher pregnancy rates. A proposed superiority study aims to compare IUI timing at 36 hours versus 42 hours post-hCG injection to evaluate its impact on live birth rates. The primary objective is to assess the effectiveness (live birth rates) of IUI at two different post-hCG timing intervals (42-43 hours vs 36-37 hours).

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 43 Years

Inclusion Criteria9

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
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
st 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 Criteria6

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

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Interventions

PROCEDUREInsemination between 42 and 43 hours post hCG

Patients will be stimulated by gonadotropins, ovulation will be blocked by a GnRH antagonist then triggered by hCG allowing IU to occur between 42 and 43 hours post hCG

PROCEDUREInsemination between 36 and 37 hours post hCG

Patients will be stimulated with gonadotropin and GnRH antagonist whose ovulation will be triggered and for which intrauterine insemination will be carried out between 36 and 37 hours post hCG