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

Beni-Suef University

Status and phase: Not yet enrolling; Phase 3

Conditions: Polycystic Ovary

Treatments: Drug: Dapagliflozin; Drug: Dapagliflozin/Metformin; Drug: Metformin; Drug: Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT06405178

Xigiduo PCO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

500 participants in 4 patient groups

Metformin 1000mg

Experimental group

Treatment:

Drug: Letrozole

Drug: Metformin

Dapagliflozin 10mg

Experimental group

Treatment:

Drug: Letrozole

Drug: Dapagliflozin

Dapagliflozin-Metformin 10/1000mg

Experimental group

Treatment:

Drug: Letrozole

Drug: Dapagliflozin/Metformin

control group.

No Intervention group