Infertile Women Undergoing IVF or ICSINCT07170137
Comparison of Uterine Distension in Hysterosonography Among Patients Monitored for Infertility
An observational study of Infertile Women Undergoing IVF or ICSI and Distension by Volumetric Analysis of the Uterus, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
Comparison of differences in distension by volumetric analysis of the uterus before and after distension between groups of infertile and apparently fertile women. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertile Women Undergoing IVF or ICSI, Distension by Volumetric Analysis of the Uterus
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2025to 15 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult
Study population: women seeking assisted reproductive technology (ART)
Who may be able to join
- Patient age ≥ 18 and < 43 years old
- No contraindications to pregnancy
- Patients consulting at the Saint Denis assisted reproductive technology (ART) department due to desire to become pregnant or infertility
Who cannot join
- Contraindication to assisted reproductive technology treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre hospitalier Delafontaine
Saint-Denis, 93200
Mika Manivet, Doctor, 01.42.35.61.40, coordination.rechercheclinique@ghtpdfr.fr
About this study
Comparison of differences in distension by volumetric analysis of the uterus before and after distension between groups of infertile and apparently fertile women.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| infertile women | Not described | |
| fertile women | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
uterine distension
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start15 Jul 2025
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertile Women Undergoing IVF or ICSIStudies 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170137
- Sponsor's protocol ID
- 0112.1_PMA
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Uterine Distension in Hysterosonography Among Patients Monitored for Infertility
- ClinicalTrials.gov ID
- NCT07170137
- Acronym / sponsor ID
- 0112.1_PMA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 12 Sep 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.
Comparison of differences in distension by volumetric analysis of the uterus before and after distension between groups of infertile and apparently fertile women.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infertile women | – | – |
| fertile women | – | – |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- women seeking assisted reproductive technology (ART)
Key inclusion criteria (3 listed)
- Patient age ≥ 18 and < 43 years old
- No contraindications to pregnancy
- Patients consulting at the Saint Denis assisted reproductive technology (ART) department due to desire to become pregnant or infertility
Key exclusion criteria (1 listed)
- Contraindication to assisted reproductive technology treatment
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
uterine distension
Time frame: 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
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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.
Centre hospitalier Delafontaine
Saint-Denis, France
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 Infertile Women Undergoing IVF or ICSI and Distension by Volumetric Analysis of the Uterus, run by Centre Hospitalier de Saint-Denis 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 3 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: looking for participants now, as of the sponsor's last update on 12 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uterine distension (time frame: 1 years). 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 12 Sep 2025.