Combined Chromium With Letrozole Versus Letrozole Only in Induction of Ovulation in Patients With Polycystic Ovary Syndrome

March 13, 2023 updated by: Mohammed salah Nasr, Cairo University

Letrozole and Chromium

Combined letrozole with chromium versus letrozole only in induction of ovulation in polycystic ovary syndrome

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled trial

Study Type

Observational

Enrollment (Actual)

90

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

  • Egypt
    • القاهره
      • Cairo, القاهره, Egypt
        • Faculty of medicine

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Female patients aged from 18 to 35 years

Description

Inclusion Criteria:

  • female patients aged from 18 to 35 years Anovulatory cycles Pcos

Exclusion Criteria:

  • female patients aged more than 35years Male factor of infertility Other factors of infertility than pcos

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Letrozole
Letrozole versus letrozole with chromium
Drug: Letrozole with chromium
Letrozole versus letrozole with chromium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of letrozole
Time Frame: 12 months
efficacy of letrozole with chromium in improving induction of ovulation
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Miscarriage rate
Time Frame: 12 months
Incidence of OHSS
12 months

Collaborators and Investigators

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

Sponsor

Cairo University

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)

September 1, 2018

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Now no plan

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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