To compare whether combination of letrozole and clomiphene is more effective than letrozole alone for egg development in women who are unable to conceive due to PCOS (improper egg development)

Comparison of Letrozole versus combination Letrozole and Clomiphene Citrate (CC) for ovulation induction in sub fertile women with polycystic ovarian syndrome (PCOS)- A randomized control trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026263

Enrollment

120

Registered

2020-07-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N970- Female infertility associated withanovulation

Interventions

Intervention1: Combination Letrozole and Clomiphene.: Participants in the study arm will be given Letrozole 2.5 mg with 50 mg Clomiphene per day, once daily, orally from 2nd day of menstrual cycle to

Eligibility

Inclusion criteria

Inclusion criteria: All subfertile women aged 21-40 yrs with diagnosis of PCOS by Rotterdamâ??s criteria

Exclusion criteria

Exclusion criteria: Women who underwent ovulation induction within last 3 months. Previously treated with Letrozole for more than 3 cycles. Use of hormonal contraception or insulin sensitizing agents in last 3 months. Other known causes of infertility endometriosis, severe male factor infertility. Chronic liver/ renal disease Uncorrected thyroid disorder Untreated hyperprolactinema Allergic or contraindications to Letrozole and Clomiphene.

Design outcomes

Primary

Measure	Time frame
Ovulation rate per cycleTimepoint: One month from the start of intervention	—

Secondary

Measure	Time frame
Cancellation rates (due to hype response)Timepoint: One to three months from the start of intervention;Clinical pregnancy rate per cycleTimepoint: Two to Six months from the start of intervention.;Cumulative ongoing pregnancy rate per woman randomizedTimepoint: Eight to nine months from the start of intervention.;Cumulative pregnancy rate per woman randomizedTimepoint: Five to Six months from the start of intervention;Miscarriage rateTimepoint: Five to six months from the start of intervention;Multiple pregnancy rateTimepoint: Two to six months from the start of intervention.;Number of women with adverse drug reactions.Timepoint: One to three months from the start of intervention;Ongoing pregnancy rate per cycleTimepoint: Four to eight months from the start of intervention	—

Measure

Time frame

Cancellation rates (due to hype response)Timepoint: One to three months from the start of intervention;Clinical pregnancy rate per cycleTimepoint: Two to Six months from the start of intervention.;Cumulative ongoing pregnancy rate per woman randomizedTimepoint: Eight to nine months from the start of intervention.;Cumulative pregnancy rate per woman randomizedTimepoint: Five to Six months from the start of intervention;Miscarriage rateTimepoint: Five to six months from the start of intervention;Multiple pregnancy rateTimepoint: Two to six months from the start of intervention.;Number of women with adverse drug reactions.Timepoint: One to three months from the start of intervention;Ongoing pregnancy rate per cycleTimepoint: Four to eight months from the start of intervention

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Countries

India

Contacts

Public ContactAleyamma TK

Christian Medical College and Hospital

draleyammatk@hotmail.com9443630074

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026