Use of Metabolomics for the Identification of Endometrial Biomarkers for IRPL and RIF After in Vi… (NCT03690830) | Clinical Trial Compass
UnknownNot Applicable
Use of Metabolomics for the Identification of Endometrial Biomarkers for IRPL and RIF After in Vitro Fertilization
France40 participantsStarted 2019-01-01
Plain-language summary
It is a case-control study composed of 3 groups : 2 cases groups (RIF and IRPL) already composed as part of a pre-existing research project and 1 control group including patients undergoing ART for male factor infertility.
The purpose of this study is to compare the 2 case group with the control group to identify metabolomics signatures.
Who can participate
Age range
18 Years – 39 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:
* Age between 18 (included) and 40 years (excluded).
* Patients who agreed to participate and signed the consent form
* Patients undergoing ART for male factor infertility: male partner with severe oligoasthenospermia or azoospermia.
* Patients without any prior history of infertility or risk factors for infertility other than the male factor.
* Patients with a normal basic infertility workup prior to ART (Day 3 serum FSH, LH, Estradiol and AMH; Antral follicle count; hysterosonography or hysterosalpingography)
Exclusion Criteria:
* Non-French speaking patients.
* Major patients that are wards of the nation.
* Patients deprived of their liberty on criminal charges or for civil reasons.
* Patients under psychiatric care.
* Patients under legal protection.
* Patients unable to sign consent forms.
* Patients not covered by social security (which covers all treatments administered).
* Patients currently participating in other interventional research projects.
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
Analyze the endometrial samples with mass spectrometry using the Biocrates kit (measures 188 metabolites)