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

NCT06405178 | Not Yet Recruiting Phase 3

• 1 other identifier: Xigiduo PCO
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary

Keywords

Sodium-Glucose Co-Transporter-2 Inhibitors; Letrozole; Ovulation; Polycystic Ovarian Syndrome

Outcome Measures

Primary Outcomes (1)

• Pregnancy

  Serum HCG positive

  3 cycles ( 3 months / one month for each cycle)

Study Arms (4)

Metformin 1000mg

EXPERIMENTAL

Drug: Metformin; Drug: Letrozole

Dapagliflozin 10mg

EXPERIMENTAL

Drug: Dapagliflozin; Drug: Letrozole

Dapagliflozin-Metformin 10/1000mg

EXPERIMENTAL

Drug: Dapagliflozin/Metformin; Drug: Letrozole

control group.

NO INTERVENTION

Interventions

Metformin DRUG

Insulin Sensitizer

Also known as: Glucophage 1000

Metformin 1000mg

Dapagliflozin DRUG

Sodium-Glucose Co-transporter-2

Also known as: Forxiga

Dapagliflozin 10mg

Dapagliflozin/Metformin DRUG

Anti diabetic drug

Also known as: Xigduo

Dapagliflozin-Metformin 10/1000mg

Letrozole DRUG

Aromataze inhibitor

Also known as: femara

Dapagliflozin 10mg; Dapagliflozin-Metformin 10/1000mg; Metformin 1000mg

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, 62511, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin; dapagliflozin; Letrozole

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sara A Beni-Suef University, MD

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara S Sara Salem, MD

CONTACT

+201272842226; sara_abdallah100@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

• First Submitted: May 4, 2024
• First Posted: May 8, 2024
• Study Start: September 30, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)