Adding cabergoline to letrozole for ovulation in PCOS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized controlled trial at Bangladesh Medical University comparing combined cabergoline plus letrozole to letrozole alone for ovulation induction in women with PCOS. Eligible participants (age 18–35, PCOS by Rotterdam criteria, seeking fertility) are randomized by permuted blocks with allocation concealed in opaque sealed envelopes. The intervention arm receives cabergoline 0.5 mg on cycle days 2 and 9 plus letrozole 5 mg daily for five days starting cycle day 2, while the comparator receives letrozole alone; transvaginal ultrasound monitoring is performed across up to three cycles to track ovarian response. Outcomes include ovulation rate and related fertility measures, with standard exclusions for other infertility causes, high prolactin, extreme BMI, uncontrolled medical disease, and certain concomitant medications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. PCOS patients diagnosed according to Rotterdam criteria.
2. Age: 18-35 years.
3. Primary or secondary subfertility.
4. Selected for ovulation induction.

Exclusion Criteria:

1. Women suffered from PCOS like symptom ex. Late onset congenital adrenal hyperplasia, Cushing syndrome.
2. Serum prolactin (more than 50 ng/ml) (Kyritsi et al., 2018).
3. Male factor infertility.
4. Women with other infertility factors (endometriosis, PID,uterine \& tubal causes of infertility).
5. Uncontrolled Medical disease (DM, HTN, kidney disease, liver disease).
6. History of hypersensitivity to cabergoline \& letrozole.
7. Thyroid dysfunction ( serum TSH ≥5mIU/L)
8. BMI:\< 18.5 kg/m2 and ≥30 kg/m2.
9. Patients on metformin therapy.
10. Patient on antiemetic like Domperidone metoclopramide, antipsychotic drug like haloperidol and risperidone, tricyclic antidepressant like amitriptyline, clomipramine, antihypertensive like verapamil, methyldopa, reserpine.

Where it's running

• Bangladesh Medical University
  Dhaka, Shahbag, Bangladesh Recruiting

Study contacts

• Study coordinator: Mst.Sumyara Khatun, MS
• Email: sumirmc09@gmail.com
• Phone: +8801746046581

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.