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

NCT06804538 | Recruiting

• 1 other identifier: RC31/24/0309
• Study Type: interventional
• Target: 692
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Infertility; Intrauterine Insemination (IUI)

Keywords

intrauterine insemination; infertility; sperm donation; timing; live birth

Outcome Measures

Primary Outcomes (1)

• Delivery rate after 22 weeks of pregnancy with at least one live birth per woman

  The live birth rate is the most relevant clinical criterion for judging the effectiveness (success) of the IUI attempt. This criterion will be evaluated according to the usual procedures of the centers via the obligatory collection of post-ART childbirth data and transmission in a regulatory manner to the Biomedicine Agency.

  the day of delivery

Secondary Outcomes (3)

• Biochemical pregnancy rate

  The day of the pregnancy test: 15 days after insemination (T0)

• Clinical pregnancy rate

  During ultrasound realised at 6 weeks' amenorrhea (SA)

• Spontaneous miscarriage rate

  The day of delivery before 22 weeks of pregnancy

Study Arms (2)

Experimental group: insemination between 42 and 43 hours post hCG

EXPERIMENTAL

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

Procedure: Insemination between 42 and 43 hours post hCG

Control group: insemination between 36 and 37 hours post hCG

ACTIVE COMPARATOR

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).

Procedure: Insemination between 36 and 37 hours post hCG

Interventions

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

Control group: insemination between 36 and 37 hours post hCG

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

Experimental group: insemination between 42 and 43 hours post hCG

Eligibility Criteria

• Age: 18 Years - 43 Years
• Gender Eligibility Details: 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 because the study concerns intrauterine insemination
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (4)

CHU Bordeaux

Bordeaux, France

NOT YET RECRUITING

CHU La Réunion

La Réunion, France

NOT YET RECRUITING

CHU Poitiers

Poitiers, France

NOT YET RECRUITING

CHU Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Jessika MOREAU, MD

CONTACT

567771017; moreau.je@chu-toulouse.fr

Celia BETTIOL, CRA

CONTACT

bettiol.c@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: February 3, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)