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

Endometrioma Clinical Trial

— GnRh  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737800
• Other study ID #: obgynivf
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: August 2017

Study information

• Verified date: July 2018
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• endometrioma patients

Exclusion Criteria:

• Follicle stimulating hormone(FSH)10 or more

• hydrosalpinx

• GnRh suppression in the last 12 months

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis

Intervention

Procedure:
• endometrioma aspiration
Transvaginal ultrasound guided aspiration

Drug:
• GnRh agonist ( Decapeptyl )
3 monthly doses of Decapeptyl 7.5mg intramuscular

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.

Locations

Country	Name	City	State
Egypt	Kasrelaini Hospital	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with urine pregnancy test positive 2 weeks after embryo transfer		5 months