Health TrialsbyHealthPanel

Cabergoline & Letrozole Versus Letrozole in Ovulation Induction in PCOS

ConditionPCOS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorMst.Sumyara Khatun

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

PCOS patients diagnosed according to Rotterdam criteria.

Age: 18-35 years.

Primary or secondary subfertility.

Selected for ovulation induction.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Letrozole 0.5mg

    Drug

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

  • 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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Experimental arm : Cabergoline and letrozoleExperimental treatment 1 intervention
Group B: Comparator arm : letrozoleActive comparator 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

Presence of preovulatory follicle on D12 of cycle

Preovulatory follicle will have mean diameter measuring ≥ 14 mm as detected on day 12of cycle folliculometry

Time frame
assessed by TVS within 12 days after each ovulation induction cycle ,upto 12 weeks
2

Largest follicle size on D12 of cycle

The largest follicular diameter is measured by averaging the two maximum perpendicular internal diameters of the follicle.

Time frame
Assessed by TVS,within 12 days of each ovulation induction cycle ,upto 12 weeks
3

Pregnancy

Pregnancy will be determined after missed period by serum β-hCG estimation. Serum β-hCG\> 5 mIU/mL is diagnosed as pregnancy \[ Atellica integrated clinical chemistry and immunoassay analyzer\].

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mst.Sumyara Khatun

Lead sponsor

Bangladesh Medical University

Sponsor institution

Bangladesh Medical University

Collaborator

Source ClinicalTrials.gov
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