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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07038616
Acronym
OVUL-IIU
Enrollment
158
Registered
2025-06-26
Start date
2024-10-01
Completion date
2025-10-15
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

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

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.

Interventions

None listed

Sponsors

Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of early pregnancies based on progesterone levels measured on the day of ovulation trigger6-7 weeks Gestational AgeRate of early pregnancies based on progesterone levels measured on the day of ovulation trigger

Secondary

MeasureTime frameDescription
Rate of spontaneous miscarriageFrom enrollment until 12 weeks Gestational AgeRate of spontaneous miscarriage before 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)Estradiol level will be collected for each patient 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)LH level will be collected for each patient , 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)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)
Rate of early pregnancies (HCG > 100) and ultrasound (6-7 weeks gestational age)6-7 weeks Gestational AgeRate of early pregnancies (HCG \> 100) and ultrasound (6-7 weeks gestational age)
Time between first IUI and early pregnancy (HCG > 100 (UI/L)From first IUI until HCG > 100 (UI/L)Time between first IUI and early pregnancy (HCG \> 100 (UI/L)
Predictive factor for pregnancy: BMI ( kg/m^2)From enrollment until the morning of insemination (between 1 and 4 hours before insemination)Predictive factor for pregnancy: BMI
Predictive factor for pregnancy:number of inseminated spermatozoa (millions)From enrollment until the morning of insemination (between 1 and 4 hours before insemination)Predictive factor for pregnancy: number of inseminated spermatozoa
Predictive factor for pregnancy: age (years)From enrollment until the morning of insemination (between 1 and 4 hours before insemination)Predictive factor for pregnancy: age
Progesterone level the morning of the insemination (ng/ml)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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026