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

Study Overview
=================
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

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

Conditions
-----------------
Endometrioma

Intervention / Treatment
-----------------
* Procedure: endometrioma aspiration
* Drug: GnRh agonist ( Decapeptyl )
* Procedure: standard long stimulation protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: endometrioma patients Exclusion Criteria: Follicle stimulating hormone(FSH)10 or more hydrosalpinx GnRh suppression in the last 12 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1A endometrioma more than 5cm<br>Endometrioma aspiration GnRh agonist :Decapeptyl 3.75mg intramuscular Standard long stimulation protocol & ICSI | Procedure: endometrioma aspiration<br>* Transvaginal ultrasound guided aspiration<br>Drug: GnRh agonist ( Decapeptyl )<br>* 3 monthly doses of Decapeptyl 7.5mg intramuscular<br>* Other names: Decapeptyl;Procedure: standard long stimulation protocol<br>* 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.<br>|
| Sham Comparator: 1B endometrioma more than 5cm control<br>Endometrioma aspiration Standard long stimulation protocol & ICSI | Procedure: endometrioma aspiration<br>* Transvaginal ultrasound guided aspiration<br>Procedure: standard long stimulation protocol<br>* 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.<br>|
| Active Comparator: 2A endometrioma less than 5cm<br>Decapeptyl 3.75mg intramuscular Standard long stimulation protocol & ICSI | Drug: GnRh agonist ( Decapeptyl )<br>* 3 monthly doses of Decapeptyl 7.5mg intramuscular<br>* Other names: Decapeptyl;Procedure: standard long stimulation protocol<br>* 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.<br>|
| Sham Comparator: 2B endometrioma less than 5cm control<br>Standard long stimulation protocol & ICSI | Procedure: standard long stimulation protocol<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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