Comparison of Clomid and Lezra With Lezra for Ovulation I... | NCT06813118

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

NCT06813118

Sponsor

HITEC-Institute of Medical Sciences

Status

Completed

Last Update Posted

May 7, 2026Actual

Enrollment

42Actual

Phase

Phase 1

Conditions

Polycystic Ovarian Syndrome

Interventions

Clomiphene Citrate and letrozole

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 7, 2024Actual

Primary Completion Date

Mar 25, 2025Actual

Completion Date

Mar 25, 2025Actual

First Submitted Date

Sep 13, 2024

First Submission Date that Met QC Criteria

Feb 3, 2025

First Posted Date

Feb 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2026

Last Update Posted Date

May 7, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rukhsana Shaheen Afzal, Assistant Professor, HITEC-Institute of Medical SciencesPrincipal Investigator

Lead Sponsor

HITEC-Institute of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1	Experimental	clomiphene citrate and letrozole combination	Drug: Clomiphene Citrate and letrozole
group 2	Experimental	letrozole alone	Drug: Clomiphene Citrate and letrozole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clomiphene Citrate and letrozole	Drug	clomiphene citrate 100mg once daily along with letrozole 5mg to one group and letrozole 5mg to second group	group 1 group 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rukhsana Shaheen Afzal, MBBS,FCPS	HITEC-Institute of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HIT Hospital		Rawalpindi	Punjab Province	47080	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002996	Clomiphene
D000077289	Letrozole
D004364	Pharmaceutical Preparations

Ancestor Terms

ID	Term
D013267	Stilbenes
D001597	Benzylidene Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided