RecruitingNot ApplicableNCT07255911

Cabergoline & Letrozole Versus Letrozole in Ovulation Induction in PCOS

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


Sponsor

Mst.Sumyara Khatun

Enrollment

72 participants

Start Date

Feb 7, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 35 Years

Inclusion Criteria4

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

Exclusion Criteria10

  • 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.

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Interventions

DRUGLetrozole 0.5mg

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

COMBINATION_PRODUCTCabergoline 0.5 mg

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.


Locations(1)

Bangladesh Medical University

Dhaka, Shahbag, Bangladesh

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NCT07255911


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