study to assess efficacy of extended regimen of letrozole in infertile women with polycystic ovarian syndrome

Efficacy of extended regimen of letrozole in infertile women with polycystic ovarian syndrome: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/059166

Enrollment

Registered

2023-10-26

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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 Health Condition 2: E282- Polycystic ovarian syndrome

Interventions

Intervention1: Letrozole extended regimen for ovulation induction: Tablet letrozole (Aromatase inhibitor) 2.5 mg once daily per oral for 10 days given from day 2-11 of menstrual cycle for ovulation in

Eligibility

Inclusion criteria

Inclusion criteria: Any patient from 21-38 years attending gynaecology OPD with features of PCOS as per modified Rotterdam criteria i.e. with 2/3 features: Oligo/anovulation, clinical and/or biochemical evidence of hyperandrogenism Normal husband semen parameters as per sixth edition WHO semen analysis 2021 criteria. Patient with at least one patent fallopian tube confirmed by hysterosalpingography or laparoscopy. Patient with controlled thyroid disorders. Patient with normal prolactin levels. Patient with no ovarian surgery. Patient who are not on any hormonal contraception or insulin sensitizers in last 3 months.

Exclusion criteria

Exclusion criteria: Patients less than 21 years and more than 38 years. Patient with history of endometriosis. Patient with diminished ovarian reserve (AMH 10 IU/ml). Patient with uncontrolled thyroid disorder. Patient with hyperprolactinemia. Patient with non-classical congenital adrenal hyperplasia.

Design outcomes

Primary

Measure	Time frame
Development of at least one follicle 16mm diameter with ovulation induction cycle by extended letrozole regimen as well as the standard regimenTimepoint: 18 days	—

Secondary

Measure	Time frame
Number of different sizes of dominant follicles developed in each group. To correlate S.AMH levels with follicular response in both groups. Need for Injection Gonadotropin. Ovarian hyperstimulation syndrome rate (OHSS). Clinical pregnancy rate. Cycle cancellation rate. Abortion rate. Timepoint: 3 ovulation induction cycles	—

Countries

India

Contacts

Public ContactBhavneet Kaur

AIIMS NEW DELHI

drarchanaaiims0312@gmail.com9888704201

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026