Convergent Mechanisms Underlying Reprometabolic Syndrome in Women (NCT06686537) | Clinical Trial Compass
RecruitingPhase 2
Convergent Mechanisms Underlying Reprometabolic Syndrome in Women
United States20 participantsStarted 2025-02-25
Plain-language summary
Dr. Nanette Santoro proposes to test the specific question that obesity results in abnormal estradiol response at the level of the pituitary and hypothalamus. This will be shown in diminished pituitary sensitivity to gonadorelin releasing hormone with a reduced estradiol induced luteinizing hormone surge in obese women.
Who can participate
Age range
18 Years – 38 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 18-38
* Regular menstrual cycles every 25-35 days
* No use of reproductive hormones within the past 3 months
* No use of medications interacting with reproductive hormones
* Agreement to use reliable barrier contraception or to abstain from intercourse for the duration of the study
* Normal thyroid stimulating hormone, prolactin and lipid profiles
* No more than 4 hours of moderate to vigorous intensity exercise per week
* No history of chronic disease impacting reproductive hormones
* No contraindications to administration of estradiol
* No history of estrogen dependent cancer
* Negative pregnancy test
Exclusion Criteria:
* Has diabetes
* Is a smoker
* History of venous thromboembolism or known thrombophilia
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.
1This trial is specifically studying something called 'reprometabolic syndrome' in women with obesity and infertility — does my particular situation fit what they're looking at, and is this even relevant to my diagnosis?
2Since the main thing they're measuring is the luteinizing hormone surge, can you explain what that means for my fertility and whether understanding my LH levels could change my treatment plan regardless of whether I join a trial?
3This is a Phase 2 study, which means safety and effectiveness are still being actively investigated — what is currently known versus still uncertain about the approaches being tested here, and how does that affect your recommendation for me?
4Would it make more sense for me to try standard fertility or weight-management treatments first before considering a research study like this one, or could participating here actually give me access to something I wouldn't otherwise get?
5What would my participation actually involve day-to-day — things like clinic visits, hormone monitoring, or lifestyle requirements — and is that realistic given my current schedule and health situation??
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
Amount of Luteinizing hormone Surge
Timeframe: From enrollment to the end of treatment is 7 days.