Sodium-Glucose Co-Transporter-2 Inhibitors as Adjuvant Therapy With Letrozole in Induction of Ovulation

Conditions

• Induction of Ovulation

Eligibility Criteria

Sex

FEMALE

Age

20 Years - 40 Years

Healthy Volunteers

Accepted

Interventions

• Metformin 1000 mg — DRUG
  will take Metformin 1000 mg once daily with a main meal and started one month before initiation of the first cycle of induction.
• Dapagliflozin 10 mg — DRUG
  will take Dapagliflozin 10mg once daily with a main meal and started one month before initiation of the first cycle of induction.
• Combined Dapagliflozin-Metformin 5/1000mg — DRUG
  will take Combined Dapagliflozin-Metformin 5/1000mg once daily with a main meal and started one month before initiation of the first cycle of induction.
• Letrozole 2.5Mg Tablet — DRUG
  will take letrozole 2.5mg twice daily from the third day of the cycle for 5 days.

Study Details

The aim of the study is to assess the efficacy of adjuvant therapy dapagliflozin, metformin as monotherapy and combination of both in comparison to control group in induction of ovulation with letrozole in women PCOS, focusing specifically on rates of ovulation and pregnancy.

Key Dates

Start date

Oct 20, 2023

Status verified

Aug 2025

Primary completion

Jul 1, 2024

Completion

Oct 30, 2025

Study Design

Enrollment

500 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: "metformin"
  will take Metformin 1000mg as adjuvant therapy
• Experimental: "Dapagliflozin"
  will take Dapagliflozin 10mg as adjuvant therapy
• Experimental: "Dapagliflozin-Metformin"
  will take combined Dapagliflozin-Metformin 5/1000 as adjuvant therapy
• Other: "control"
  will take letrozole 2.5mg the no adjuvant therapy

Primary Outcome Measure

Ovulation rate [ Time Frame: "through study completion, an average of 1 year". ]