Evaluation of Anti-mullerian Hormone(AMH) Levels as a Predictive Factor of Response to Weight Los… (NCT01792362) | Clinical Trial Compass
CompletedPhase 3
Evaluation of Anti-mullerian Hormone(AMH) Levels as a Predictive Factor of Response to Weight Loss Treatment in Obese Infertile Women With Poly Cystic Ovary(PCOS)
Iran60 participantsStarted 2012-10
Plain-language summary
This study is a prospective before \& after clinical trial to compare the basal and 3 months after diet anti-mullerian hormone levels between responders and non-responders to weight loss diet in obese infertile women with PCOS population
Who can participate
Age range
18 Years – 40 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:
\- 1- diagnosis of PCOS, according to the Rotterdam Consensus Workshop Group, by 2 of the following 3 criteria: menstrual irregularity (cycle length\<26 d or \>31 d or variation between consecutive cycles of \>3 d); clinical (hirsutism assessed by a Ferriman-Gallwey score \> 8) or biochemical \[free androgen index (FAI) \> 5.4 or testosterone\_1.4 nmol/L\] hyperandrogenism; or positive ultrasound presentation of polycystic ovaries by transvaginal scan.
2- Age between 18 -40
Exclusion Criteria:
\- 1. Body mass index (BMI; in kg/m2) \< 30, 2. Type 2 diabetes mellitus and related endocrinopathic disorders \[identified by assessment of thyroid-stimulating hormone (TSH), prolactin, and 17\_hydroxyprogesterone\].
3\. Regular exercise activities during the study. 4. Cases of alcoholism and smoking. 5. The use of endocrine hormonal treatment or insulin-sensitizing agents is not permitted during either phase of the study, and the use of oral contraceptives is not permitted during of the study. Subjects are required to cease taking oral contraceptives 4 wk and hormonal treatment or insulin-sensitizing agents 2 wk before commencement of the short-term study phase.
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.