Clinical trial NCT06405178: Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome
Official title: Sodium-Glucose Co-Transporter-2 Inhibitors as Adjuvant Therapy With Letrozole in Induction of Ovulation in Women With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Polycystic Ovary
Keywords: Sodium-Glucose Co-Transporter-2 Inhibitors
Letrozole
Ovulation
Polycystic Ovarian Syndrome
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pregnancy
timeFrame: 3 cycles ( 3 months / one month for each cycle)
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university Hospital
Study officials:
affiliation: Beni-Suef University
name: Sara A Beni-Suef University, MD
role: PRINCIPAL_INVESTIGATOR
References: