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

NCT07038616 | Completed

• 1 other identifier: OVUL-IIU
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

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).

Conditions

Infertility

Keywords

Stimulated cycle; intrauterine insemination; clinical pregnancy rate; donor sperm; progesterone; ovulation induction; ovulation

Outcome Measures

Primary Outcomes (1)

• Rate of early pregnancies based on progesterone levels measured on the day of ovulation trigger

  Rate of early pregnancies based on progesterone levels measured on the day of ovulation trigger

  6-7 weeks Gestational Age

Secondary Outcomes (10)

• Rate of early pregnancies (HCG > 100) and ultrasound (6-7 weeks gestational age)

  6-7 weeks Gestational Age

• Rate of spontaneous miscarriage

  From enrollment until 12 weeks Gestational Age

• Estradiol level the morning of the insemination (pg/ml)

  The morning of the insemination (between 1 and 4 hours before the insemination)

• LH level the morning of the insemination (UI/L)

  The morning of the insemination (between 1 and 4 hours before the insemination)

• hCG level the morning of the insemination (UI/L)

  The morning of the insemination (between 1 and 4 hours before the insemination)

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of single women or couples, heterosexual or homosexual, undergoing insemination at a medically assisted procreation (MAP) center. Participants are aged between 18 and 43 years old. They have an indication for intrauterine insemination (IUI) in accordance with the Recommendations for Good Practices in Assisted Reproductive Medicine (RBP). . Only those who have had a blood as part of routine care on the day of insemination, will be included in the study.

You may qualify if:

• 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

You may not qualify if:

• Opposition of patients to data collection

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

Chi Creteil

Créteil, CHI Créteil, 94000, France

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 26, 2025
• Study Start: October 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 15, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

FR (1)