Actively Recruiting

Phase Not Applicable
Age: 18Years - 35Years
FEMALE
ID07255911

Cabergoline and Letrozole Compared to Letrozole Alone for Ovulation Induction in Infertile Women With Polycystic Ovary Syndrome

Led by Mst.Sumyara Khatun · Updated on 2025-12-16

72

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

Sponsors

M

Mst.Sumyara Khatun

Lead Sponsor

B

Bangladesh Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying women with polycystic ovary syndrome (PCOS) who are seeking to become pregnant. The study compares whether combining two drugs, cabergoline and letrozole, helps increase the rate of ovulation better than using letrozole alone. This randomized controlled trial involves participants diagnosed with PCOS according to the Rotterdam criteria and focuses on ovulation induction to improve fertility outcomes. Participants are randomly assigned to one of two groups. The experimental group takes cabergoline tablets twice on days 2 and 9 of their menstrual cycle plus letrozole tablets daily for five days starting on day 2. The comparison group takes only letrozole tablets daily for five days starting on day 2. Treatments continue for up to three menstrual cycles. Ovarian response is monitored using transvaginal ultrasound to check follicle growth on day 12 of each cycle. Participants will attend multiple visits each cycle for initial assessments, medication administration, ultrasound monitoring, and blood tests to confirm ovulation by measuring progesterone levels. Pregnancy testing and ultrasound for fetal heartbeat are done if menstruation is missed. The main outcome measured is ovulation rate within 21 days after each cycle, with additional monitoring of follicle size, ovulation confirmation, and pregnancy occurrence over 12 weeks.

CONDITIONS

Brief Title

Cabergoline & Letrozole Versus Letrozole in Ovulation Induction in PCOS

Who Can Participate

Age: 18Years - 35Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam criteria
  • Age between 18 and 35 years
  • Primary or secondary subfertility
  • Selected for ovulation induction
Not Eligible

You will not qualify if you...

  • Women with PCOS-like symptoms such as late onset congenital adrenal hyperplasia or Cushing syndrome
  • Serum prolactin levels over 50 ng/ml
  • Male factor infertility
  • Other infertility causes like endometriosis, pelvic inflammatory disease, uterine or tubal problems
  • Uncontrolled medical diseases including diabetes, hypertension, kidney or liver disease
  • History of allergy to cabergoline or letrozole
  • Thyroid dysfunction with serum TSH 5 mIU/L or higher
  • Body mass index below 18.5 or above 30 kg/m2
  • Current metformin therapy
  • Use of certain medications including domperidone, metoclopramide, haloperidol, risperidone, amitriptyline, clomipramine, verapamil, methyldopa, or reserpine

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 3 menstrual cycles (approximately 12 weeks)

Participants receive ovulation induction treatment with cabergoline plus letrozole or letrozole alone for up to 3 menstrual cycles. Treatment starts on day 2 of menstruation or withdrawal bleeding each cycle. Participants take medications and undergo monitoring of follicle growth and ovulation confirmation.

At least four visits per cycle: baseline assessment, ovulation induction, follicle monitoring on day 12, and serum progesterone measurement for ovulation confirmation; additional visits for pregnancy testing if period is missed

Trial Site Locations

Total: 1 location

1

Bangladesh Medical University

Dhaka, Shahbag, Bangladesh, 1000

Actively Recruiting

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Research Team

M

Mst.Sumyara Khatun, MS

N

Nespatul Jannat, MBBS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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