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Trial · Interventional

Status unknownPhase 4Registry data

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

NCTNCT04094467 (opens ClinicalTrials.gov in a new tab)Other idPCOS-ICSI
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
150 participants (estimated)
Sponsor
Assiut University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Egypt

Start
7 Dec 2019
Primary completion
Oct 2020 (estimated)
Completion
Jan 2021 (estimated)
First posted
19 Sept 2019
Last update posted
25 Mar 2020
Conditions
Polycystic Ovary Syndrome

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph 4

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

    NCT04094467

    7 Dec 2019 to est. Jan 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • CetrorelixDrug
  • Leuprolide AcetateDrug

Arms2

  • Experimental

    Study group

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

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The difference in clinical pregnancy rate in both groups

    Time frame · 6 weeks

    Registry description

    ultrasound detection of fetal heart pulsations

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 35 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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