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)
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility |
Other: Weight loss diet |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Blood level of AMH [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Evaluation of Blood level of AMH 12 weeks after weight loss.
- Basal level of AMH [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]Evaluation the Basal level of AMH before starting weight loss diet
- Sensitivity of basal AMH level [ Time Frame: 6 months ] [ Designated as safety issue: No ]Evaluation the Sensitivity of basal AMH level for predict the response to weight loss diet
- specificity of basal AMH level [ Time Frame: 6 months ] [ Designated as safety issue: No ]Evaluation the specificity of basal AMH level for predict the response to weight loss diet
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AMH
obese PCOS patients who underwent weight loss diet
|
Other: Weight loss diet
Control the patients diet to make them loosing weight
|
Detailed Description:
The study population comprised of all obese infertile PCOS patients aged 20-40 years which underwent 3 months weight loss diet in royan institute, Tehran Iran.
The study is conducted over 12 wk energy restriction. All subjects have the same dietary protocol. At baseline, week 12 the levels of AMH,Follicular Stimulating Hormone (FSH), Lutienizing Hormone(LH),Prolactin (PRL), androgens, sex hormone-binding globulin (SHBG), glucose, and insulin were measured and Free Androgen Index (FAI) and Insulin Resistance (IR) indices is calculated. The laboratory tests are determined by radioimmunoassay in the Laboratory of Endocrinology of Royan institute. AMH is measured in duplicate using an ultrasensitive ELISA kit (AMH-ELIZA Kit; Beckman Coulter, Marseilles, France) according to manufacturer instructions. All measurements are performed using a single kit and at the same time in the Laboratory of clinical Immunology of Royan institute.
Data collection will be performed by using questionnaire to be filled as per the available records and laboratory results. Data analysis will be done through descriptive and perceptive statistical methods.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Nasser Aghdami, MD,PhD | +9821235622000 ext 504 | nasser.aghdami@royaninstitute.org |
| Contact: Leila Arab, MD | +982123562000 ext 414 | leila.arab@yahoo.com |
| Iran, Islamic Republic of | |
| Royan Institute | Recruiting |
| Tehran, Iran, Islamic Republic of | |
| Contact: Nasser Aghdami, MD,PhD +982123562000 ext 504 nasser.aghdami@royaninstitute.org | |
| Contact: Leila Arab, MD +982123562000 ext 414 leila.arab@yahoo.com | |
| Principal Investigator: Mandana Hemmat, MD | |
| Sub-Investigator: Arezoo Arabipour, MSc | |
| Sub-Investigator: Reza Salmanyazdi, PhD | |
| Sub-Investigator: Ali Akhlaghi, MSc | |
| Sub-Investigator: Jila Ahmadi, BSc | |
| Study Chair: | Hamid Gourabi, PhD | Head of Royan Institute |
| Study Director: | Ashraf Moini, MD | Department of Endocrinology and Female Infertility, Reproductive Biomedicine Center, Royan institute for Reproductive Biomedicine, ACECR, Tehran, Iran |
More Information
Additional Information:
No publications provided
| Responsible Party: | Royan Institute |
| ClinicalTrials.gov Identifier: | NCT01792362 History of Changes |
| Other Study ID Numbers: | Royan-Emb-015 |
| Study First Received: | February 13, 2013 |
| Last Updated: | February 13, 2013 |
| Health Authority: | Iran: Ethics Committee Iran: Ministry of Health |
Keywords provided by Royan Institute:
|
Anti-mullerian hormone (AMH) level, poly cystic ovarian syndrome obese infertility weight loss diet |
Additional relevant MeSH terms:
|
Infertility Weight Loss Genital Diseases, Male Genital Diseases, Female Body Weight Changes Body Weight |
Signs and Symptoms Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013