Infertility Clinical Trial
Official title:
Comparing the Basal Anti-mullerian Hormone Levels Between Responders and Non-responders to Weight Loss Diet in Obese Infertile Women With PCOS Population
Verified date | November 2012 |
Source | Royan Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ethics CommitteeIran: Ministry of Health |
Study type | Interventional |
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
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2014 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Royan Institute | Tehran |
Lead Sponsor | Collaborator |
---|---|
Royan Institute |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood level of AMH | Evaluation of Blood level of AMH 12 weeks after weight loss. | 3 months | Yes |
Primary | Basal level of AMH | Evaluation the Basal level of AMH before starting weight loss diet | 1 week | Yes |
Secondary | Sensitivity of basal AMH level | Evaluation the Sensitivity of basal AMH level for predict the response to weight loss diet | 6 months | No |
Secondary | specificity of basal AMH level | Evaluation the specificity of basal AMH level for predict the response to weight loss diet | 6 months | No |
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