Adding cabergoline to letrozole for ovulation in PCOS

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

This study will see if adding cabergoline to letrozole helps women with PCOS ovulate more often.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 35 Years
• Sex: Female
• Sponsor: Bangladesh Medical University (Academic / other)
• Locations: 1 site (Dhaka, Shahbag)
• Trial ID: NCT07255911 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Women aged 18–35 with PCOS by Rotterdam criteria who have primary or secondary subfertility, meet BMI and lab limits, and are selected for ovulation induction are ideal candidates.

Not a fit: Women with other infertility causes (male factor, tubal or uterine disease), very high prolactin, uncontrolled medical conditions, extreme BMI, or those taking excluded medications are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could increase ovulation rates and improve chances of conception for women with PCOS seeking fertility.

How similar studies have performed: Letrozole is established for ovulation induction and dopamine agonists are used for hyperprolactinemia, but combining cabergoline with letrozole for ovulation induction is not well established and supporting evidence is limited.

Eligibility criteria

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 this trial is running

Dhaka, Shahbag

• Bangladesh Medical University — Dhaka, Shahbag, Bangladesh (Recruiting)

Study contacts

• Study coordinator: Mst.Sumyara Khatun, MS

Conditions PCOS; ovulation induction by Cabergoline