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

NCT ID: NCT06405178

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2024-12-30

Brief Summary

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.

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.

Conditions

Polycystic Ovary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Metformin 1000mg

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Insulin Sensitizer

Letrozole

Intervention Type: DRUG

Aromataze inhibitor

Dapagliflozin 10mg

Group Type: EXPERIMENTAL

Dapagliflozin

Intervention Type: DRUG

Sodium-Glucose Co-transporter-2

Letrozole

Intervention Type: DRUG

Aromataze inhibitor

Dapagliflozin-Metformin 10/1000mg

Group Type: EXPERIMENTAL

Dapagliflozin/Metformin

Intervention Type: DRUG

Anti diabetic drug

Letrozole

Intervention Type: DRUG

Aromataze inhibitor

control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Metformin

Insulin Sensitizer

Intervention Type: DRUG

Dapagliflozin

Sodium-Glucose Co-transporter-2

Intervention Type: DRUG

Dapagliflozin/Metformin

Anti diabetic drug

Intervention Type: DRUG

Letrozole

Aromataze inhibitor

Intervention Type: DRUG

Other Intervention Names

Glucophage 1000; Forxiga; Xigduo; femara

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Sara Abdallah Mohamed Salem

principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara A Beni-Suef University, MD

Role: PRINCIPAL_INVESTIGATOR

Beni-Suef University

Locations

Beni-suef university Hospital

Banī Suwayf, , Egypt

Countries

Egypt

Central Contacts

Sara S Sara Salem, MD

Role: CONTACT

sara_abdallah100@yahoo.com

+201272842226

Other Identifiers

Xigiduo PCO

Identifier Type: -

Identifier Source: org_study_id