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

Polycystic Ovary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06405178
• Other study ID #: Xigiduo PCO
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 30, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: Beni-Suef University
• Contact: Sara S Sara Salem, MD
• Phone: +201272842226
• Email: sara_abdallah100[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary
• Polycystic Ovary Syndrome

Intervention

Drug:
• Metformin
Insulin Sensitizer
• Dapagliflozin
Sodium-Glucose Co-transporter-2
• Dapagliflozin/Metformin
Anti diabetic drug
• Letrozole
Aromataze inhibitor

Locations

Country	Name	City	State
Egypt	Beni-suef university Hospital	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy	Serum HCG positive	3 cycles ( 3 months / one month for each cycle)