Comparison Between Two Different Protocols in Polycystic Ovary Symdrome Women Undergoing Intra-cytoplasmic Injection

March 23, 2020 updated by: Ahmed Mohamed Abbas, Assiut University

CLASSICAL ANTAGONIST PROTOCOL IN COMPARISON WITH AGONIST STOP PROTOCOL IN Polycystic Ovary Symdrome WOMEN UNDERGOING Intra-cytoplasmic Injection TRIAL: a Randomized Controlled Trial

Stein and Leventhal were the first to recognize an association between the presence of polycystic ovaries and signs of hirsutism and amenorrhea (eg,oligomenorrhea, obesity), After women diagnosed with Stein-Leventhal syndrome underwent successful wedge resection of the ovaries, their menstrual cycles became regular, and they were able to conceive. As a consequence, a primary ovarian defect was thought to be the main culprit, and the disorder came to be known as polycystic ovarian disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

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
    • Cairo
      • Assiut, Cairo, Egypt, 002
        • Recruiting
        • Ahmed Abbas
        • Contact:
          • Ahmed Abbas
        • Contact:

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 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women under 35 years with polycystic ovary syndrome criteria
  2. Normal male semen parameters
  3. Normal tubes either by hysterosalpingography &/or laparoscopy
  4. Free from other endocrine abnormalities

Exclusion Criteria:

  1. NON polycystic ovary syndrome Criteria
  2. More than 35 years
  3. Abnormal semen parameters
  4. Pathological tube& pelvic factor
  5. Other endocrine disorders

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
the antagonist protocol group" where they will do intra-cytoplasmic injection using classical antagonist protocol
Drug: Cetrorelix
0.25 mg subcutaneous injection daily for 6 days
Active Comparator: control group
"agonist stop/antagonist protocol group" where they will receive mid luteal agonist in the preceding intra-cytoplasmic injection cycle before starting classical antagonist protocol
Drug: Cetrorelix
0.25 mg subcutaneous injection daily for 6 days
Drug: Leuprolide Acetate
0.1 mg subcutaneous injection daily for 12 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in clinical pregnancy rate in both groups
Time Frame: 6 weeks
ultrasound detection of fetal heart pulsations
6 weeks

Collaborators and Investigators

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

Sponsor

Assiut 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)

December 7, 2019

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

September 17, 2019

First Submitted That Met QC Criteria

September 17, 2019

First Posted (Actual)

September 19, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCOS-ICSI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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