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NCT Number: NCT07038616

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

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).

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Key information

Age range

18 year–43 year

Sex eligibility

Female

Study type

Observational

Primary location

Chi Creteil

Créteil, CHI Créteil, 94000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 6-7 weeks Gestational Age

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

Secondary outcomes

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

    Time frame: 6-7 weeks Gestational Age

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

  2. Rate of spontaneous miscarriage

    Time frame: From enrollment until 12 weeks Gestational Age

    Rate of spontaneous miscarriage before 12 weeks Gestational Age

  3. Estradiol level the morning of the insemination (pg/ml)

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

    Estradiol level will be collected for each patient The morning of the insemination (between 1 and 4 hours before the insemination)

  4. LH level the morning of the insemination (UI/L)

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

    LH level will be collected for each patient , the morning of the insemination (between 1 and 4 hours before the insemination)

  5. hCG level the morning of the insemination (UI/L)

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

    hCG level will be collected for each patient , the morning of the insemination (between 1 and 4 hours before the insemination)and 4 hours before the insemination)

  6. Progesterone level the morning of the insemination (ng/ml)

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

    Progesterone level will be collected for each patient , the morning of the insemination (between 1 and 4 hours before the insemination)

  7. Time between first IUI and early pregnancy (HCG > 100 (UI/L)

    Time frame: From first IUI until HCG > 100 (UI/L)

    Time between first IUI and early pregnancy (HCG > 100 (UI/L)

  8. Predictive factor for pregnancy: BMI ( kg/m^2)

    Time frame: From enrollment until the morning of insemination (between 1 and 4 hours before insemination)

    Predictive factor for pregnancy: BMI

  9. Predictive factor for pregnancy:number of inseminated spermatozoa (millions)

    Time frame: From enrollment until the morning of insemination (between 1 and 4 hours before insemination)

    Predictive factor for pregnancy: number of inseminated spermatozoa

  10. Predictive factor for pregnancy: age (years)

    Time frame: From enrollment until the morning of insemination (between 1 and 4 hours before insemination)

    Predictive factor for pregnancy: age

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Official study title

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

Acronym: OVUL-IIU

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 26, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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