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

Primary Purpose

Endometrioma

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
endometrioma aspiration
GnRh agonist ( Decapeptyl )
standard long stimulation protocol
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrioma

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • endometrioma patients

Exclusion Criteria:

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

Sites / Locations

  • Kasrelaini Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

1A endometrioma more than 5cm

1B endometrioma more than 5cm control

2A endometrioma less than 5cm

2B endometrioma less than 5cm control

Arm Description

Endometrioma aspiration GnRh agonist :Decapeptyl 3.75mg intramuscular Standard long stimulation protocol & ICSI

Endometrioma aspiration Standard long stimulation protocol & ICSI

Decapeptyl 3.75mg intramuscular Standard long stimulation protocol & ICSI

Standard long stimulation protocol & ICSI

Outcomes

Primary Outcome Measures

Number of patients with urine pregnancy test positive 2 weeks after embryo transfer

Secondary Outcome Measures

Full Information

First Posted
March 31, 2016
Last Updated
July 27, 2018
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02737800
Brief Title
Effect of Prolonged GnRh Agonists on Results of Intracytoplasmic Sperm Injection (ICSI ) in Endometrioma Patients
Acronym
GnRh
Official Title
Effect of Prolonged GnRh Agonist Therapy on the Outcome of In-Vitro Fertilization& Embryo Transfer in Endometrioma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1A endometrioma more than 5cm
Arm Type
Active Comparator
Arm Description
Endometrioma aspiration GnRh agonist :Decapeptyl 3.75mg intramuscular Standard long stimulation protocol & ICSI
Arm Title
1B endometrioma more than 5cm control
Arm Type
Sham Comparator
Arm Description
Endometrioma aspiration Standard long stimulation protocol & ICSI
Arm Title
2A endometrioma less than 5cm
Arm Type
Active Comparator
Arm Description
Decapeptyl 3.75mg intramuscular Standard long stimulation protocol & ICSI
Arm Title
2B endometrioma less than 5cm control
Arm Type
Sham Comparator
Arm Description
Standard long stimulation protocol & ICSI
Intervention Type
Procedure
Intervention Name(s)
endometrioma aspiration
Intervention Description
Transvaginal ultrasound guided aspiration
Intervention Type
Drug
Intervention Name(s)
GnRh agonist ( Decapeptyl )
Other Intervention Name(s)
Decapeptyl
Intervention Description
3 monthly doses of Decapeptyl 7.5mg intramuscular
Intervention Type
Procedure
Intervention Name(s)
standard long stimulation protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients with urine pregnancy test positive 2 weeks after embryo transfer
Time Frame
5 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: endometrioma patients Exclusion Criteria: Follicle stimulating hormone(FSH)10 or more hydrosalpinx GnRh suppression in the last 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
suzy abdelaziz, lecturer
Organizational Affiliation
Kasr El Aini Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasrelaini Hospital
City
Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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