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

NCT ID: NCT04094467

Last Updated: 2020-03-25

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-07

Study Completion Date

2021-01-31

Brief Summary

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

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.

Detailed Description

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

Conditions

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

Polycystic Ovary 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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Study group

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

Group Type EXPERIMENTAL

Cetrorelix

Intervention Type DRUG

0.25 mg subcutaneous injection daily for 6 days

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

Group Type ACTIVE_COMPARATOR

Cetrorelix

Intervention Type DRUG

0.25 mg subcutaneous injection daily for 6 days

Leuprolide Acetate

Intervention Type DRUG

0.1 mg subcutaneous injection daily for 12 days

Interventions

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

Cetrorelix

0.25 mg subcutaneous injection daily for 6 days

Intervention Type DRUG

Leuprolide Acetate

0.1 mg subcutaneous injection daily for 12 days

Intervention Type DRUG

Eligibility Criteria

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

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

Assiut University

OTHER

Sponsor Role lead

Responsible Party

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

Ahmed Mohamed Abbas

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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

Egypt

Central Contacts

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

Mohammed Smeeh, MSc

Role: CONTACT

00201001737769

Facility Contacts

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

ahmed abbas, MD

Role: primary

ahmed abbas

Role: backup

Other Identifiers

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

PCOS-ICSI

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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