InfertilityOVUL-IIUNCT07038616
Observation of the Response to Ovulation Triggering on the Day of Intrauterine Insemination and Correlation Between Progesterone Level and Pregnancy Rate (OVUL-IIU)
An observational study of Infertility, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility
- How many people
- 158 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2024to 15 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- -Opposition of patients to data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observation of the Response to Ovulation Induction 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.
Read more
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).
Read the 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
- Keywords
- Stimulated cycle, intrauterine insemination, clinical pregnancy rate, donor sperm, progesterone, ovulation induction, ovulation
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-7 weeks Gestational Age
Secondary outcomes (10)
Rate of early pregnancies (HCG > 100) and ultrasound (6-7 weeks gestational age)
Rate of early pregnancies (HCG > 100) and ultrasound (6-7 weeks gestational age)
Measured: 6-7 weeks Gestational Age
Rate of spontaneous miscarriage
Rate of spontaneous miscarriage before 12 weeks Gestational Age
Measured: From enrollment until 12 weeks Gestational Age
Estradiol level the morning of the insemination (pg/ml)
Estradiol level will be collected for each patient The morning of the insemination (between 1 and 4 hours before the insemination)
Measured: The morning of the insemination (between 1 and 4 hours before the insemination)
LH level the morning of the insemination (UI/L)
LH level will be collected for each patient , the morning of the insemination (between 1 and 4 hours before the insemination)
Measured: The morning of the insemination (between 1 and 4 hours before the insemination)
hCG level the morning of the insemination (UI/L)
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)
Measured: The morning of the insemination (between 1 and 4 hours before the insemination)
Progesterone level the morning of the insemination (ng/ml)
Progesterone level will be collected for each patient , the morning of the insemination (between 1 and 4 hours before the insemination)
Measured: The morning of the insemination (between 1 and 4 hours before the insemination)
Time between first IUI and early pregnancy (HCG > 100 (UI/L)
Time between first IUI and early pregnancy (HCG > 100 (UI/L)
Measured: From first IUI until HCG > 100 (UI/L)
Predictive factor for pregnancy: BMI ( kg/m^2)
Predictive factor for pregnancy: BMI
Measured: From enrollment until the morning of insemination (between 1 and 4 hours before insemination)
Predictive factor for pregnancy:number of inseminated spermatozoa (millions)
Predictive factor for pregnancy: number of inseminated spermatozoa
Measured: From enrollment until the morning of insemination (between 1 and 4 hours before insemination)
Predictive factor for pregnancy: age (years)
Predictive factor for pregnancy: age
Measured: From enrollment until the morning of insemination (between 1 and 4 hours before insemination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Oct 2024
- Primary completion1 Oct 2024
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038616
- Sponsor's protocol ID
- OVUL-IIU
- Acronym
- OVUL-IIU
- Status last verified
- Dec 2025
- First submitted
- 19 May 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of the Response to Ovulation Induction on the Day of Intrauterine Insemination and Correlation Between Progesterone Level and Pregnancy Rate (OVUL-IIU)
- ClinicalTrials.gov ID
- NCT07038616
- Acronym / sponsor ID
- OVUL-IIU / OVUL-IIU
- Conditions
- Infertility
- Keywords
- Stimulated cycle, intrauterine insemination, clinical pregnancy rate, donor sperm, progesterone, ovulation induction, ovulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -Opposition of patients to data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
Rate of early pregnancies (HCG > 100) and ultrasound (6-7 weeks gestational age)
Time frame: 6-7 weeks Gestational Age
Rate of spontaneous miscarriage
Time frame: From enrollment until 12 weeks Gestational Age
Estradiol level the morning of the insemination (pg/ml)
Time frame: The morning of the insemination (between 1 and 4 hours before the insemination)
LH 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 the morning of the insemination (UI/L)
Time frame: The morning of the insemination (between 1 and 4 hours before the insemination)
Progesterone level the morning of the insemination (ng/ml)
Time frame: The morning of the insemination (between 1 and 4 hours before the insemination)
Time between first IUI and early pregnancy (HCG > 100 (UI/L)
Time frame: From first IUI until HCG > 100 (UI/L)
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: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: age (years)
Time frame: From enrollment until the morning of insemination (between 1 and 4 hours before insemination)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of early pregnancies based on progesterone levels measured on the day of ovulation trigger (time frame: 6-7 weeks Gestational Age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.