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

NCT ID: NCT06813118

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-07

Study Completion Date

2025-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovarian Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomization intervention RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
lottery method for selection

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group 1

clomiphene citrate and letrozole combination

Group Type EXPERIMENTAL

Clomiphene Citrate and letrozole

Intervention Type DRUG

clomiphene citrate 100mg once daily along with letrozole 5mg to one group and letrozole 5mg to second group

group 2

letrozole alone

Group Type EXPERIMENTAL

Clomiphene Citrate and letrozole

Intervention Type DRUG

clomiphene citrate 100mg once daily along with letrozole 5mg to one group and letrozole 5mg to second group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clomiphene Citrate and letrozole

clomiphene citrate 100mg once daily along with letrozole 5mg to one group and letrozole 5mg to second group

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

drugs

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

HITEC-Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rukhsana Shaheen Afzal

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rukhsana Shaheen Afzal, MBBS,FCPS

Role: PRINCIPAL_INVESTIGATOR

HITEC-Institute of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

HIT Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rukhsana Shaheen Afzal, MBBS,FCPS

Role: CONTACT

03339014943

Tahira Jabeen, MBBS,FCPS

Role: CONTACT

03121519011

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Rukhsana Shaheen Afzal, MBBS,FCPS

Role: primary

0333 9014943

Tahira Jabeen, MBBS,FCPS

Role: backup

0312 1519011

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HITECIMSTAXILLA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pregnancy in Polycystic Ovary Syndrome II
NCT00719186 COMPLETED PHASE3