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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 43
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Bordeaux
NOT_YET_RECRUITING
Bordeaux
CHU La Réunion
NOT_YET_RECRUITING
La Réunion
CHU Poitiers
NOT_YET_RECRUITING
Poitiers
CHU Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Jessika MOREAU, MD
moreau.je@chu-toulouse.fr
567771017
Backup
Celia BETTIOL, CRA
bettiol.c@chu-toulouse.fr
Time Frame
Start Date: 2025-09-09
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 692
Treatments
Experimental: Experimental group: insemination between 42 and 43 hours post hCG
Patients in the experimental group 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. These treatments are similar to the control group. Only the timing of the IUI compared to the timing of ovulation triggering is different
Active_comparator: Control group: insemination between 36 and 37 hours post hCG
In the comparison group, 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 (as it is already the case in clinical practice).
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov