Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
Intervention1: Individualized advise on diet & physical activity: Each participant will be given a customized advise on diet and exercise by dietician and physiotherapist. They will be assessed at 3 a
Sponsors
INDIAN COUNCIL OF MEDICAL RESEARCH
Eligibility
Inclusion criteria
Inclusion criteria: Body mass index = 23 kg/m2 to = 35 kg/m2 Willing to participate in the study
Exclusion criteria
Exclusion criteria: Participants who cannot come for the follow up Diabetes mellitus, Inflammatory arthritis or any lower limb pathology which precludes exercise Gastro intestinal conditions such as Ulcerative colitis, Crohns disease which require special dietary advise Other known causes of infertility which needs ART: Severe endometriosis, Severe male factor infertility Male partner with azoospermia Documented severe tubal bilateral pathology Patients on metformin for glycemic control or other antiglycemic medicines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth per woman randomized Time to pregnancyTimepoint: Work Elements Time (months) Planning, ethics approval and staff recruitment 0-3 months orientation and training of staff 0-4 months Subjects screening 3-45 months Subject randomization 4- 50 months Annual update and review 13-14 month and repeat at 24th, 36th and 48th month Interim analysis 30 months Recruitment and randomization to stop 48-50 months Analysis of data, result analysis 55-58 month Submit final report and publications 58-60 months | — |
Secondary
| Measure | Time frame |
|---|---|
| # Ongoing pregnancy rate # Clinical pregnancy rate # Miscarriage rate # Mean weight loss # Improvement in menstrual regularity (According to FIGO 2018 guidelines variation of cycle to be called regular is 7-9 days depending on age. Age 18–25 years =9 days; Age 26–41 years =7 days is regular) # Differences in anthropometric parameters (Waist circumference, hip circumference, neck circumference, waist hip ratio and waist height ratio) at the end of the trial period # Improvement in hormonal and metabolic parameters (biochemical markers such as lipid profile and blood sugar) over the baseline # Quality of life (PCOS specific) assessment. (Cronin et al., PCOS QOL questionnaire) Timepoint: Work Elements Time (months) Planning, ethics approval and staff recruitment 0-3 months orientation and training of staff 0-4 months Subjects screening 3-45 months Subject randomization 4- 50 months Annual update and review 13-14 month and repeat at 24th, 36th and 48th month Interim analysis 30 months Recruitment and randomization to stop 48-50 months Analysis of data, result analysis 55-58 month Submit final report and publications 58-60 months | — |
Countries
India
Contacts
Public ContactDr Neena Malhotra
AIIMS New Delhi
Outcome results
None listed