Endometrial Response in Polycystic Ovarian Syndrome Treated With Letrozole Alone or With Added Estradiol Valerate

January 27, 2026 updated by: Maryum Noor Malik, CMH Kharian Medical College

Endometrial Response in Women With Poorly Primed Endometrial Lining in Diagnosed Polycystic Ovarian Syndrome Treated With Letrozole Alone or With Added Estradiol Valerate

Polycystic Ovary Syndrome (PCOS) is one of the most common endocrine disorders among women of reproductive age, characterized by chronic anovulation, hyperandrogenism, and polycystic ovarian morphology. Letrozole, an aromatase inhibitor, has emerged as a first-line ovulation induction agent due to its superior ovulation and pregnancy rates compared to clomiphene citrate. Estradiol valerate, a synthetic estrogen, can be co-administered with letrozole to improve endometrial receptivity by enhancing endometrial thickness, vascularity, and pattern. This study aims to evaluate the effect of letrozole alone versus letrozole with estradiol valerate on endometrial development in these patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Polycystic Ovary Syndrome (PCOS) is one of the most common endocrine disorders among women of reproductive age, characterized by chronic anovulation, hyperandrogenism, and polycystic ovarian morphology. Letrozole, an aromatase inhibitor, has emerged as a first-line ovulation induction agent due to its superior ovulation and pregnancy rates compared to clomiphene citrate. However, one of the drawbacks of aromatase inhibitors is suboptimal endometrial development, which may adversely affect implantation and pregnancy outcomes.

Estradiol valerate, a synthetic estrogen, can be co-administered with letrozole to improve endometrial receptivity by enhancing endometrial thickness, vascularity, and pattern. Limited data exist on whether adding estradiol to letrozole truly improves the endometrial response and clinical pregnancy rates in women with PCOS. This study aims to evaluate the effect of letrozole alone versus letrozole with estradiol valerate on endometrial development in these patients.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mushayada Irshad, MBBS, Mphil, CHPE
  • Phone Number: +923237088421
  • Email: mishy2360@gmail.com

Study Locations

  • Pakistan
    • Punjab Province
      • Khārian, Punjab Province, Pakistan, 50070
        • CMH Kharian Medical College
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maryum Noor Malik, MBBS, FCPS, CHPE
        • Sub-Investigator:
          • Mugheera Hussain, MBBS, FCPS, MRCPI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged 20-35 years
  • Clinical diagnosis of PCOS (Rotterdam criteria)

Exclusion Criteria:

  • Endocrine disorders other than PCOS
  • Endometrial pathology or uterine malformations
  • Allergy to letrozole or estradiol
  • Hormonal therapy within last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: letrozole
30 participants with PCOs will receive tab letrozole 2.5mg 2 x OD for 5 days
Drug: Letrozole (Aromatase Inhibitors)
30 participants with PCOs will receive tab letrozole 2.5mg 2 x OD for 5 days
Experimental: letrozole plus estradiol valerate
30 participants with PCOs will receive tab letrozole 2.5mg 2 x OD for 5 days plus tab Estradiol valerate 2mg OD for 12 days
Drug: Letrozole (Aromatase Inhibitors) + Estradiol valerate
30 participants with PCOs will receive tab letrozole 2.5mg 2 x OD for 5 days plus tab Estradiol valerate 2mg OD for 12 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometrial thickness (mm) on day of ovulation trigger
Time Frame: 12th day of cycle 1 (Each cycle is 28 days)
Endometrial thickness will be measured on Transvaginal ultrasound on 12th day in a 28 day menstrual cycle.
12th day of cycle 1 (Each cycle is 28 days)
Pattern of endometrium (Trilaminar or Non-trilaminar) on the day of ovulation trigger
Time Frame: 12th day of cycle 1 (Each cycle is 28 days)
Endometrial pattern will be seen on Transvaginal ultrasound on 12th day in a 28 day menstrual cycle
12th day of cycle 1 (Each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CMH Kharian Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 5, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CKMC/IERB/AC-00256

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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