Observation of the Response to Ovulation Triggering on the Day of Intrauterine Insemination and Correlation Between Progesterone Level and Pregnancy Rate (OVUL-IIU)

NCT ID: NCT07038616

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 158 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-10-15

Brief Summary

Intrauterine inseminations (IUI) are a commonly used technique in assisted reproductive technology (ART) to help women conceive, whether within a couple or as single individuals. However, national success rates remain modest, with an average live birth rate of 10% per cycle, which leads many ART centers to favor in vitro fertilization (IVF) as a more effective option.

Nevertheless, IUI retains several advantages: it is less invasive, less expensive, and, when appropriately indicated, can achieve satisfactory outcomes.

Guidelines exist for ovarian stimulation protocols prior to IUI, aimed at optimizing the chances of success. So far, no clear superiority has been demonstrated between pharmacological ovulation triggering and spontaneous ovulation. However, accurate timing of insemination in relation to ovulation is recognized as a key factor for success.

Very few studies have focused on the response to ovulation triggering, and none have explored a correlation with clinical pregnancy rates.

Yet, monitoring of the luteal phase and response to ovulation triggering is a common practice in ART, particularly in the context of frozen embryo transfers (FET), suggesting that these parameters may be worth further investigation in the context of IUI.

Hence, the interest of this study is to determine whether there is a correlation between progesterone levels and clinical pregnancy rates in patients undergoing intrauterine insemination (IUI).

Detailed Description

This is a single-center observational cohort study with retrospective and prospective data collection.

Participation in the study is offered in the CHIC MPA department. Data will be collected over a 12-month period.

The research consists of retrieving data from the patient's and spouse's medical records and from software for presenting biological laboratory results .

Patients and their spouses will be informed of the study orally, and will receive a written information note.

Conditions

Infertility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• Single women or couples, heterosexual or homosexual, undergoing insemination at the medically assisted procreation.center
• Aged 18 to 43
• Any indication for IUI in compliance with the Recommendations for Good Practices in MPA (RBP)
• Blood test on the day of insemination with estradiol, progesterone, LH and hCG measured as part of routine care

Exclusion Criteria

-Opposition of patients to data collection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chi Creteil

Créteil, CHI Créteil, France

Countries

France

Other Identifiers

OVUL-IIU

Identifier Type: -

Identifier Source: org_study_id