Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine A… (NCT02328742) | Clinical Trial Compass
WithdrawnNot Applicable
Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions.
Stopped: Feasibility issues require solutions.
France0Started 2015-11
Plain-language summary
The main objective of this study is to describe the level of expression of the biological factors involved in the formation of adhesions (Transforming growth factor beta, Activin A, inhibin) at the time of a first diagnostic hysteroscopy among women with synechia, another intracavitary disease or no intracavitary disease.
Who can participate
Age range
18 Years – 44 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The patient must be given free and informed consent and must have signed the consent form
* The patient must be affiliated with or beneficiary of a health insurance plan
* Indication for hysteroscopy associated with one of the following: infertility evaluation, postoperative dysmenorrhea, embryo implantation failure after invitro fertilization, recurrent miscarriages
Exclusion Criteria:
* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, guardianship or curatorship
* The patient refuses to sign the consent
* It is not possible to correctly inform the patient
* The patient is postmenopausal
* Indication of hysteroscopy not associated with exploration of infertility or dysmenorrhea
* Presence of endometritis objectified via sampling during diagnostic hysteroscopy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Activin A
Timeframe: Day 0 (day of diagnostic hysteroscopy)
2
Inhibin
Timeframe: Day 0 (day of diagnostic hysteroscopy)
3
Transforming growth factor beta
Timeframe: Day 0 (day of diagnostic hysteroscopy)
4
Diagnosis of synechia or other intracavitary pathology