NCT06804538 Interest of Sperm Insemination at 42 Hours Post hCG Compared to 36h in Intrauterine Insemination
| NCT ID | NCT06804538 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 692 participants |
| Start Date | 2025-09-09 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 692 participants in total. It began in 2025-09-09 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06804538 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 43 Years, studying Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06804538 currently recruiting?
Yes, NCT06804538 is actively recruiting participants. Contact the research team at moreau.je@chu-toulouse.fr for enrollment information.
Where is the NCT06804538 trial being conducted?
This trial is being conducted at Bordeaux, France, La Réunion, France, Poitiers, France, Toulouse, France.
Who is sponsoring the NCT06804538 clinical trial?
NCT06804538 is sponsored by University Hospital, Toulouse. The trial plans to enroll 692 participants.