Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary
• Intervention / Treatment: Drug: Metformin; Drug: Letrozole; Drug: Dapagliflozin; Drug: Dapagliflozin/Metformin

Detailed Description

The study will be a randomized controlled clinical trial. Once the eligibility from screening visit is determined prior to baseline visit, randomization will be made by computer randomization for women who are admitted to Beni-Suef University Hospital.

• Before initiation of the study, the population will be divided randomly into 4 equal groups: group A, B, C and D. The adjuvant therapy of each group will be group (A) Metformin 1000mg, group (B) Dapagliflozin 10mg, Group(C) Combined Dapagliflozin-Metformin 10/1000mg and group (D) with no adjuvant therapy (control group).
• The adjuvant therapy will be taken once daily with a main meal and started one month before initiation of letrozole. All groups will take letrozole 2.5mg twice daily from the third day of the cycle for 5 days.

This treatment regimen will continue for three cycles unless positive pregnancy is achieved. No diet restriction will be recommended during the study or change in the lifestyle. The population will be asked to inform about any side effects that may happen during the study. A written informed consent will be obtained from each woman participating in the study.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Banī Suwayf, Egypt, 62511
    • Beni-Suef University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• PCOS will based on European Society of Human Reproduction and Embryology/American Society for Reproductive Medicine (ESHRE/ASRM) criteria, the diagnosis is made when at least two of the following criteria are met:

  • oilgo and/or anovulation (infrequent or no ovulation),
  • clinical and/or biochemical signs of hyperandrogenism including hirsutism, acne and/or increased testosterone levels
  • polycystic ovaries on ultrasound (defined as those containing at least 12 follicles measuring 2-9 mm in diameter arranged peripherally around an echo-dense stroma and/or with increased ovarian volume of at least 10 ml).

Exclusion Criteria:

• Other causes of hyperandrogenism mimic PCOS such as congenital adrenal hyperplasia, Cushing's syndrome, or androgen secreting tumors are excluded.
• Persistent hyperprolactinemia,
• thyroid dysfunction defined as TSH < 0.2 mIU/ML or >5.5 mIU/mL)
• patients with menopausal levels of FSH (> 15 mIU/mL) (A normal level within the last year is adequate for enter the study).
• Liver disease is defined as AST or ALT > 2 times normal or total bilirubin >2.5 mg/dL, #kidney disease defined as BUN > 30 mg/dL or serum creatinine> 1.4 mg/dL or significant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metformin 1000mg	Drug: Metformin; Insulin Sensitizer; Other Names: Glucophage 1000; Drug: Letrozole; Aromataze inhibitor; Other Names: femara
Experimental: Dapagliflozin 10mg	Drug: Letrozole; Aromataze inhibitor; Other Names: femara; Drug: Dapagliflozin; Sodium-Glucose Co-transporter-2; Other Names: Forxiga
Experimental: Dapagliflozin-Metformin 10/1000mg	Drug: Letrozole; Aromataze inhibitor; Other Names: femara; Drug: Dapagliflozin/Metformin; Anti diabetic drug; Other Names: Xigduo
No Intervention: control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy	Serum HCG positive	3 cycles ( 3 months / one month for each cycle)

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Sara A Beni-Suef University, MD, Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2026
• Primary Completion (Actual): March 30, 2026
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: May 4, 2024
• First Submitted That Met QC Criteria: May 4, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Ovulation; Polycystic Ovarian Syndrome; Letrozole; Sodium-Glucose Co-Transporter-2 Inhibitors
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Polycystic Ovary Syndrome; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Nitriles; Biguanides; Guanidines; Amidines; Triazoles; Letrozole; Metformin; dapagliflozin
• Other Study ID Numbers: Xigiduo PCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No