Feasibility of diet and exercise as a treatment option for women with Polycystic ovarian syndrome who desire fertility: a preliminary study
Not Applicable
- Conditions
- Health Condition 1: N970- Female infertility associated withanovulation
- Registration Number
- CTRI/2021/12/038831
- Lead Sponsor
- Cristian Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
PCOS women diagnosed by Rotterdam criteria aged between 18 â?? 40 years wishing to conceive.
Body mass index >= 23 kg/m2
Exclusion Criteria
Diabetes mellitus,
Inflammatory arthritis or any lower limb pathology which precludes exercise
GI conditions such as Ulcerative colitis, Crohns disease which require special dietary advise
Other known causes of infertility such as:
Severe endometriosis,
Severe male factor infertility
Male partner with azoospermia
Documented tubal bilateral pathology
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome: Number of participants completing the intervention ( Drop out rate)Timepoint: At the end of 6th month.
- Secondary Outcome Measures
Name Time Method on compliance rate <br/ ><br>Mean Weight loss <br/ ><br>Reasons for refusal to participate in the trial <br/ ><br>Reasons for refusal to be randomized after initially agreeing to participate in the trial <br/ ><br>Reasons for drop out (discontinuation of the lifestyle intervention i.e. customized diet / exercise advise) <br/ ><br>Reasons for non compliance to the lifestyle intervention i.e. customized diet/exercise <br/ ><br>Improvement in menstrual regularity <br/ ><br>improvement in anthropometric parameters (Waist circumference ,Hip circumference, neck circumference, waist hip ratio and waist height ratio) <br/ ><br>Quality of life (PCOS specific) assessment. <br/ ><br>Timepoint: At the end of 6th month.