Effect of Prolonged GnRh Agonists on Results of Intracytoplasmic Sperm Injection (ICSI ) in Endometrioma Patients (GnRh)

July 27, 2018 updated by: suzy abdelaziz Abdelhamid, Kasr El Aini Hospital

Effect of Prolonged GnRh Agonist Therapy on the Outcome of In-Vitro Fertilization& Embryo Transfer in Endometrioma Patients

Investigators compare ICSI results for endometrioma patients with or without cyst aspiration if more than 5cm &with or without GnRh agonists for all endometrioma patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Group 1 consists of 30 patients of endometrioma more than 5cm subdivided into:

Group 1A;Cyst aspiration followed by standard long protocol in 15 patients Group 1B;Cyst aspiration followed by GnRh suppression for 3 months then standard long protocol in 15 patients

Group 2 consists of 30 patients of endometrioma less than 5cm subdivided into :

Group 2A;no intervention to the cyst. Standard long protocol Group 2B;GnRh suppression for 3 months then standard long protocol

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • kasrelaini hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • endometrioma patients

Exclusion Criteria:

  • Follicle stimulating hormone(FSH)10 or more
  • hydrosalpinx
  • GnRh suppression in the last 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1A endometrioma more than 5cm
Endometrioma aspiration GnRh agonist :Decapeptyl 3.75mg intramuscular Standard long stimulation protocol & ICSI
Procedure: endometrioma aspiration
Transvaginal ultrasound guided aspiration
Drug: GnRh agonist ( Decapeptyl )
3 monthly doses of Decapeptyl 7.5mg intramuscular
Other Names:
  • Decapeptyl
Procedure: standard long stimulation protocol
Decapeptyl 3.75mg in the mid luteal phase followed by human menopausal gonadotropins(HMG);fostimon, or merional injections after bleeding, doses are individualization according to each patient, monitored by follicular size &serum estradiol.
Sham Comparator: 1B endometrioma more than 5cm control
Endometrioma aspiration Standard long stimulation protocol & ICSI
Procedure: endometrioma aspiration
Transvaginal ultrasound guided aspiration
Procedure: standard long stimulation protocol
Decapeptyl 3.75mg in the mid luteal phase followed by human menopausal gonadotropins(HMG);fostimon, or merional injections after bleeding, doses are individualization according to each patient, monitored by follicular size &serum estradiol.
Active Comparator: 2A endometrioma less than 5cm
Decapeptyl 3.75mg intramuscular Standard long stimulation protocol & ICSI
Drug: GnRh agonist ( Decapeptyl )
3 monthly doses of Decapeptyl 7.5mg intramuscular
Other Names:
  • Decapeptyl
Procedure: standard long stimulation protocol
Decapeptyl 3.75mg in the mid luteal phase followed by human menopausal gonadotropins(HMG);fostimon, or merional injections after bleeding, doses are individualization according to each patient, monitored by follicular size &serum estradiol.
Sham Comparator: 2B endometrioma less than 5cm control
Standard long stimulation protocol & ICSI
Procedure: standard long stimulation protocol
Decapeptyl 3.75mg in the mid luteal phase followed by human menopausal gonadotropins(HMG);fostimon, or merional injections after bleeding, doses are individualization according to each patient, monitored by follicular size &serum estradiol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with urine pregnancy test positive 2 weeks after embryo transfer
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: suzy abdelaziz, lecturer, Kasr El Aini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

April 9, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 27, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • obgynivf

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometrioma

Clinical Trials on endometrioma aspiration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe