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

Sponsor
University Hospital, Toulouse
Study ID
NCT06804538
Status
Recruiting
Apply to this trial

Conditions

  • Infertility
  • Intrauterine Insemination (IUI)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 43 Years
Healthy Volunteers
Not accepted

Interventions

  • Insemination between 42 and 43 hours post hCG — PROCEDURE
    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
  • Insemination between 36 and 37 hours post hCG — PROCEDURE
    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

Study Details

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).

Key Dates

First listed
Feb 3, 2025
Start date
Sep 9, 2025
Status verified
Sep 2025
Primary completion
Dec 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
692 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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).

Primary Outcome Measure

Delivery rate after 22 weeks of pregnancy with at least one live birth per woman [ Time Frame: the day of delivery ]

Central Contacts

Related Studies