Added Value of N Acetyle Cysteine to Clomiphene Citrate in PCO

April 26, 2021 updated by: Mahmoud Alalfy, Aljazeera Hospital

The Added Value of n Acetyle Cysteine and Chromium to Clomiphene Citrate in PCO

PCO is one of the factors associated with delayed conception

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In an attempt to induce ovulation Clomiphene citrate can be given in conjunction with N acetyle cysteine

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

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
      • Giza, Egypt
        • Algazeerah and Kasralainy hospital
      • Giza, Egypt
        • Algazeerah

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women with PCO

Exclusion Criteria:

  • women who donot have PCO

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: clomiphene plus metformin plus N acetyle cysteine
Women who will receive clomiphene citrate plus metformin plus n acetyle cysteine
Drug: Clomiphene plus metformin plus N acetyle cysteine in arm number 1
oral adminstration of clomiphene citrate plus metformin plus N acetyl cysteine or chromium
Other: clomiphene plus metformin plus chromium
Women who will receive clomiphene plus metformin plus chromium
Drug: Clomiphene citrate plus metformin with chromium
oral adminstration of clomiphene citrate plus metformin and chromium
Other: clomiphen citrate plus metformin
Women who will receive clomiphene plus metformin
Drug: clomiphene citrate plus metformin
oral adminstration of clomiphene citrate plus metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of women who will have mature follicles wih their size and number of mqture follicles The number of women who will have mature follicles
Time Frame: within 2 weeks
Assessment of women in both groups for size and number of follicles
within 2 weeks

Collaborators and Investigators

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

Sponsor

Aljazeera Hospital

Collaborators

Cairo University

Investigators

  • Study Director: Mahmoud Alalfy, PhD, Algezeera

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)

November 20, 2019

Primary Completion (Actual)

May 2, 2020

Study Completion (Actual)

May 15, 2020

Study Registration Dates

First Submitted

November 16, 2019

First Submitted That Met QC Criteria

November 19, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • chromium in infertility

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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