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

Not Applicable

Completed

• Conditions: Endometrioma
• Interventions: Procedure: endometrioma aspiration; Procedure: standard long stimulation protocol; Drug: GnRh agonist ( Decapeptyl )

• Registration Number: NCT02737800
• Lead Sponsor: Kasr El Aini Hospital

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

Study Timeline

• Study First Submitted: 2016-03-31
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-09
• Study First Posted: 2016-04-14
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

• endometrioma patients

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1B endometrioma more than 5cm control	endometrioma aspiration	Endometrioma aspiration Standard long stimulation protocol \& ICSI
2B endometrioma less than 5cm control	standard long stimulation protocol	Standard long stimulation protocol \& ICSI
1A endometrioma more than 5cm	standard long stimulation protocol	Endometrioma aspiration GnRh agonist :Decapeptyl 3.75mg intramuscular Standard long stimulation protocol \& ICSI
1B endometrioma more than 5cm control	standard long stimulation protocol	Endometrioma aspiration Standard long stimulation protocol \& ICSI
2A endometrioma less than 5cm	GnRh agonist ( Decapeptyl )	Decapeptyl 3.75mg intramuscular Standard long stimulation protocol \& ICSI
2A endometrioma less than 5cm	standard long stimulation protocol	Decapeptyl 3.75mg intramuscular Standard long stimulation protocol \& ICSI
1A endometrioma more than 5cm	GnRh agonist ( Decapeptyl )	Endometrioma aspiration GnRh agonist :Decapeptyl 3.75mg intramuscular Standard long stimulation protocol \& ICSI
1A endometrioma more than 5cm	endometrioma aspiration	Endometrioma aspiration GnRh agonist :Decapeptyl 3.75mg intramuscular Standard long stimulation protocol \& ICSI

Primary Outcome Measures

Name	Time	Method
Number of patients with urine pregnancy test positive 2 weeks after embryo transfer	5 months

Trial Locations

Locations (1)

Kasrelaini Hospital; 🇪🇬 Giza, Egypt