Cabergoline & Letrozole Versus Letrozole in Ovulation Induction in PCOS

NCT07255911 | Recruiting

• 1 other identifier: 5385
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Does combined Cabergoline and letrozole increase ovulation rate What medical problems do participants have when taking drug Cabergoline and Letrozole ? Researchers will compare drug combination of Cabergoline and letrozole to letrozole alone to see combined cabergoline and letrozole works better as ovulation induction. Participants will: experimental group will receive Cabergoline and Letrozole comparator group will receive letrozole alone TVS Monitoring will be done for 3 cycle for ovarian response

Conditions

PCOS

Keywords

ovulation induction by Cabergoline

Outcome Measures

Primary Outcomes (1)

• Ovulation Rate

  Ovulation will be diagnosed by presence of any one of following(Mandelbaum et al., 2024) * LH surge in ovulation predictor kit * Day 21 progesterone level ≥ 3 ng/dl * An appropriately timed menses in previously oligomenorrheic women * A positive pregnancy test

  Assessed within 21 days after each ovulation induction cycle for upto 12 weeks

Secondary Outcomes (3)

• Presence of preovulatory follicle on D12 of cycle

  assessed by TVS within 12 days after each ovulation induction cycle ,upto 12 weeks

• Largest follicle size on D12 of cycle

  Assessed by TVS,within 12 days of each ovulation induction cycle ,upto 12 weeks

• Pregnancy

  assessed if missed period occur after each ovulation induction cycle ,for upto 12 weeks

Study Arms (2)

Experimental arm : Cabergoline and letrozole

EXPERIMENTAL

participants will receive Tab. cabergoline 0.5 mg 1 tablet at night, two dose at weekly interval (day 2 and day 9 of menstruation/withdrawal bleeding) plus tab. letrozole 5 mg/day at night from day 2 menstruation/withdrawal bleeding for 5 days for consecutive 3 cycles.

Combination Product: Cabergoline 0.5 mg

Comparator arm : letrozole

ACTIVE COMPARATOR

participants will receive Tab. letrozole 5 mg/day at night from day 2 of menstruation/withdrawal bleeding for 5 days for consecutive 3 cycles.

Drug: Letrozole 0.5mg

Interventions

Letrozole 0.5mg DRUG

Tab. letrozole 5 mg/day at night from day 2 menstruation/withdrawal bleeding for 5 days for consecutive 3 cycles.

Comparator arm : letrozole

Cabergoline 0.5 mg COMBINATION_PRODUCT

Tab. cabergoline 0.5 mg 1 tablet at night, two dose at weekly interval (day 2 and day 9 of menstruation/withdrawal bleeding) plus Tab. letrozole 5 mg/day at night from day 2 of menstruation/withdrawal bleeding for 5 days for consecutive 3 cycles.

Also known as: Letrozole 2.5mg

Experimental arm : Cabergoline and letrozole

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mst.Sumyara Khatun: lead
• Bangladesh Medical University: collaborator

Study Sites (1)

Bangladesh Medical University

Dhaka, Shahbag, 1000, Bangladesh

RECRUITING

Related Publications (2)

• Delcour C, Robin G, Young J, Dewailly D. PCOS and Hyperprolactinemia: what do we know in 2019? Clin Med Insights Reprod Health. 2019 Sep 9;13:1179558119871921. doi: 10.1177/1179558119871921. eCollection 2019.

  PMID: 31523136 RESULT

• Melmed S, Casanueva FF, Hoffman AR, Kleinberg DL, Montori VM, Schlechte JA, Wass JA; Endocrine Society. Diagnosis and treatment of hyperprolactinemia: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Feb;96(2):273-88. doi: 10.1210/jc.2010-1692.

  PMID: 21296991 RESULT

MeSH Terms

Interventions

Letrozole; Cabergoline

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Mst.Sumyara Khatun, MS

CONTACT

+8801746046581; sumirmc09@gmail.com

Nespatul Jannat, MBBS

CONTACT

+8801731892425; nespatul.jannat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Officer

Model Details: open label parallel design randomized clinical trial.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: February 7, 2025
• Primary Completion: January 6, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)