Comparison of Clomid and Lezra With Lezra for Ovulation Induction in Clomid Resistant PCOS Case

May 4, 2026 updated by: Rukhsana Shaheen Afzal, HITEC-Institute of Medical Sciences

A RCT Comparing the Effectiveness of a Combination Therapy of Lezra and Clomid Versus Lezra Alone for Inducing Ovulation in Women Diagnosed With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome

Clomiphene citrate resistant i.e failure to ovulate after 6 cycles of ovulation induction effects 15-40% of patients with PCOS.Two treatment groups will be formed one recieving letrozole alone and another recieving CC and letrozole combined.Mature follicles and endometrial thickness will be checked by transvaginal ultrasound and results will be recorded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subfertility is characterized by the inability to achieve conception despite engaging in regular unprotected sexual intercourse for 1-2 years.PCOS exhibits chacteristic traits such as obesity,heightened insulin resistance accompanied by compensatory hyperinsulinemia,oligo/anovulation and subfertility.Clompiphene citrate induces ovarian stimulation.Letrozole ,an aromatase inhibitor emerges as a novel medication with comparable efficacy to CC as a first line treatment for inducing ovulation in cases of anovulation.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan, 47080
        • HIT Hospital

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

Yes

Description

Inclusion Criteria:

  • women of 20-40 years with a history of PCOS and resistant to CC

Exclusion Criteria:

  • Premature ovarian insufficiency
  • Husband has oligo azoospermia
  • Hypothyroidism
  • Hyperprolactinemia

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1
clomiphene citrate and letrozole combination
Drug: Clomiphene Citrate and letrozole
clomiphene citrate 100mg once daily along with letrozole 5mg to one group and letrozole 5mg to second group
Other Names:
  • drugs
Experimental: group 2
letrozole alone
Drug: Clomiphene Citrate and letrozole
clomiphene citrate 100mg once daily along with letrozole 5mg to one group and letrozole 5mg to second group
Other Names:
  • drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the rate of ovulation
Time Frame: 6 months
To compare the rate of ovulation between letrozole alone and letrozole and CC
6 months

Collaborators and Investigators

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

Sponsor

HITEC-Institute of Medical Sciences

Investigators

  • Principal Investigator: Rukhsana Shaheen Afzal, MBBS,FCPS, HITEC-Institute of Medical Sciences

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 (Actual)

June 7, 2024

Primary Completion (Actual)

March 25, 2025

Study Completion (Actual)

March 25, 2025

Study Registration Dates

First Submitted

September 13, 2024

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

February 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HITECIMSTAXILLA

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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