Ultrasound Characterization of Ovarian Follicle Dynamics in Women With Amenorrhea (NCT01927432) | Clinical Trial Compass
CompletedNot Applicable
Ultrasound Characterization of Ovarian Follicle Dynamics in Women With Amenorrhea
United States73 participantsStarted 2011-09
Plain-language summary
In women with regular menstrual cycles, antral follicles have been shown to grow in synchronous cohorts, called waves, 2-3 times in a menstrual cycle. It is unknown whether these waves of follicle growth also occur in women with amenorrhea or if there is abnormal/absent follicle growth. Further, oligo- or amenorrhea has been associated with metabolic disturbances, such as over- or under-nutrition, central obesity and insulin resistance. Yet, mechanisms whereby metabolic factors influence folliculogenesis in women are poorly understood. To understand potential mechanisms, the investigators plan to characterize follicle growth dynamics in women with or without regular menstrual cycles and identifying key metabolic differences in these women which may be important in normal follicle development and fertility.
Who can participate
Age range
18 Years – 35 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:
* Between 18 and 35 years
* BMI ≥ 18 kg/m2
* If ≥ 21 years old, must have had healthy pelvic exam w/in past 2 years
Either:
* Regular menstrual cycles (21-35 days);
* Irregular menstrual cycles (\>36 days) with or without a previous diagnosis of PCOS from a primary care provider
Exclusion Criteria:
* Current use of medication(s) known or suspected to interfere with reproductive function (eg. oral contraceptives) or insulin sensitivity
* Pregnant or breastfeeding
* Not otherwise healthy
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.