NCT07379502

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

November 26, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 5, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

November 26, 2025

Last Update Submit

January 27, 2026

Conditions

PCOS (Polycystic Ovary Syndrome)

Keywords

PCOS (Polycystic Ovary Syndrome)LetrozoleEstradiol ValerateEndometrial responseEndometrial thickness

Outcome Measures

Primary Outcomes (2)

  • Endometrial thickness (mm) on day of ovulation trigger

    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

    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)

Study Arms (2)

letrozole

ACTIVE COMPARATOR

30 participants with PCOs will receive tab letrozole 2.5mg 2 x OD for 5 days

Drug: Letrozole (Aromatase Inhibitors)

letrozole plus estradiol valerate

EXPERIMENTAL

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

Interventions

Letrozole (Aromatase Inhibitors)DRUG

30 participants with PCOs will receive tab letrozole 2.5mg 2 x OD for 5 days

letrozole
Letrozole (Aromatase Inhibitors) + Estradiol valerateDRUG

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

letrozole plus estradiol valerate

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMH Kharian Medical College

Khārian, Punjab Province, 50070, Pakistan

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

LetrozoleAromatase InhibitorsEstradiol

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSteroid Synthesis InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEstrogen AntagonistsHormone AntagonistsHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormones

Central Study Contacts

Maryum Noor Malik, MBBS, FCPS, CHPE

CONTACT

+923111777089maryam.n.malik24@gmail.com

Mushayada Irshad, MBBS, Mphil, CHPE

CONTACT

+923237088421mishy2360@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Registrar Ob/Gyn

Study Record Dates

First Submitted

November 26, 2025

First Posted

January 30, 2026

Study Start

March 5, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)