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

Primary Purpose

Polycystic Ovary Syndrome

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Cetrorelix

Leuprolide Acetate

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

NON polycystic ovary syndrome Criteria
More than 35 years
Abnormal semen parameters
Pathological tube& pelvic factor
Other endocrine disorders

Sites / Locations

Ahmed AbbasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

control group

Arm Description

the antagonist protocol group" where they will do intra-cytoplasmic injection using classical antagonist protocol

"agonist stop/antagonist protocol group" where they will receive mid luteal agonist in the preceding intra-cytoplasmic injection cycle before starting classical antagonist protocol

Outcomes

Primary Outcome Measures

The difference in clinical pregnancy rate in both groups

ultrasound detection of fetal heart pulsations

Secondary Outcome Measures

Full Information

NCT ID

NCT04094467

First Posted

September 17, 2019

Last Updated

March 23, 2020

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT04094467

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 7, 2019 (Actual)

Primary Completion Date

October 2020 (Anticipated)

Study Completion Date

January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Experimental

Arm Description

the antagonist protocol group" where they will do intra-cytoplasmic injection using classical antagonist protocol

Arm Title

control group

Arm Type

Active Comparator

Arm Description

"agonist stop/antagonist protocol group" where they will receive mid luteal agonist in the preceding intra-cytoplasmic injection cycle before starting classical antagonist protocol

Intervention Type

Drug

Intervention Name(s)

Cetrorelix

Intervention Description

0.25 mg subcutaneous injection daily for 6 days

Intervention Type

Drug

Intervention Name(s)

Leuprolide Acetate

Intervention Description

0.1 mg subcutaneous injection daily for 12 days

Primary Outcome Measure Information:

Title

The difference in clinical pregnancy rate in both groups

Description

ultrasound detection of fetal heart pulsations

Time Frame

6 weeks

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women under 35 years with polycystic ovary syndrome criteria Normal male semen parameters Normal tubes either by hysterosalpingography &/or laparoscopy Free from other endocrine abnormalities Exclusion Criteria: NON polycystic ovary syndrome Criteria More than 35 years Abnormal semen parameters Pathological tube& pelvic factor Other endocrine disorders

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohammed Smeeh, MSc

Phone

00201001737769

drmohamedhemida84@gmail.com

Facility Information:

Facility Name

Ahmed Abbas

City

Assiut

State/Province

Cairo

ZIP/Postal Code

002

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ahmed abbas, MD

bmr90@hotmail.com

First Name & Middle Initial & Last Name & Degree

ahmed abbas

12. IPD Sharing Statement

Learn more about this trial

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

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