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New strategies for treating Letrozole resistant PCOS patients undergoing ovulation induction

Comparison of intracycle Extended Letrozole Regimen and Gonadotropins for Letrozole-Resistant Polycystic Ovary Syndrome Patients Undergoing Ovulation Induction-A randomized controlled pilot study - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/096762
Enrollment
50
Registered
2025-11-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: extended letrozole regimen: Letrozole resistance is defined as the lack of follicular development beyond 10mm on the day 10 ultrasound scan among patients who underwent standard LE ther

Sponsors

KIMS Foundation and Research Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Women aged between 21 to 40 years with Body Mass Index (BMI) ranging from 19 to 35 kg/m². • Treatment naïve patients • Women who underwent ovulation induction elsewhere Letrozole resistance is defined as the lack of follicular development beyond 10mm on the day 10 ultrasound scan among patients who underwent standard LE therapy 5 mg for 5 days. These patients will be randomised after the day 9 scan to either extended letrozole or gonadotrophins for follicular development.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
To compare and evaluate the ovulation rate confirmed by ultrasound in both the arms. Timepoint: 4 weeks

Secondary

MeasureTime frame
To assess the number of follicles greater than or equal to 14 mm of the day of the trigger.Timepoint: on day 25;pregnancy rate confirmed by urine pregnancy test or beta HCGTimepoint: two weeks after ovulatation;To assess the incidence of multiple pregnancies and ovarian hyperstimulationTimepoint: Follow up period

Countries

India

Contacts

Public ContactVyjayanthi Srinivasan

Krishna Institute of Medical Sciences

svyjayanthi99@gmail.com9177519000

Outcome results

None listed

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