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

NCT04094467 | Unknown Phase 4

• 1 other identifier: PCOS-ICSI
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• The difference in clinical pregnancy rate in both groups

  ultrasound detection of fetal heart pulsations

  6 weeks

Study Arms (2)

Study group

EXPERIMENTAL

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

Drug: Cetrorelix

control group

ACTIVE COMPARATOR

"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; Drug: Leuprolide Acetate

Interventions

Cetrorelix DRUG

0.25 mg subcutaneous injection daily for 6 days

Study group; control group

Leuprolide Acetate DRUG

0.1 mg subcutaneous injection daily for 12 days

control group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

cetrorelix; Leuprolide

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Mohammed Smeeh, MSc

CONTACT

00201001737769; drmohamedhemida84@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: December 7, 2019
• Primary Completion: October 1, 2020
• Study Completion: January 1, 2021
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

EG (1)