Efficacy of Vitamin D Supplementation and Metformin Compared to Metformin Alone for Improvement in Follicle Size of Infertile Females With Polycystic Ovary Syndrome: a Randomized Open Label Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Objectives: To evaluate the efficacy of metformin and Vitamin D supplementation on serum insulin and serum androgen levels (Total testosterone, Steroid Hormone Binding Globulin, Free Androgen Index) levels compared metformin alone in infertile Poly cystic ovarian females of reproductive age group. Secondary Objectives: To measure change in endometrial thickness/number of follicles and follicular size by day 12 trans-vaginal ultrasound in the intervention group i.e. combination of metformin and vitamin D supplementation

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 36
Healthy Volunteers: t
View:

• Females with age range 18- 36 years, from all ethnic background having primary infertility with diagnosis of PCOS when at least 2 of these 3 elements are present: hyperandrogenism, chronic anovulation and polycystic ovaries and Vitamin D deficiency serum levels \< 25 nmol/L

Locations
Other Locations
Pakistan
Dr Rehana Rehman
RECRUITING
Karachi
Dr Rehana Rehman
RECRUITING
Karachi
Contact Information
Primary
Rehana K Rehman, PhD
drrehana7@gmail.com
00922134864460
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2025-07-13
Participants
Target number of participants: 300
Treatments
Experimental: Vitamin D supplement
The intervention group will receive VD Cholecalciferol (D2) 50,000 I.U once weekly for 12 weeks, followed by 50,000 I.U once every fortnight for 24 weeks with the Metformin treatment as prescribed by the physician whereas
No_intervention: Control
control group will receive Metformin treatment during the study period.
Sponsors
Leads: Aga Khan University

This content was sourced from clinicaltrials.gov

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