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

Assiut University

Status and phase: Unknown; Phase 4

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Leuprolide Acetate; Drug: Cetrorelix

Study type: Interventional

Funder types: Other

Identifiers

NCT04094467

PCOS-ICSI

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Study group

Experimental group

Description:

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

Treatment:

Drug: Cetrorelix

control group

Active Comparator group

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

Treatment:

Drug: Leuprolide Acetate

Drug: Cetrorelix