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

NCT ID: NCT02737800

Last Updated: 2018-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-08-31

Brief Summary

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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

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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

Conditions

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Endometrioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1A endometrioma more than 5cm

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

Group Type ACTIVE_COMPARATOR

endometrioma aspiration

Intervention Type PROCEDURE

Transvaginal ultrasound guided aspiration

GnRh agonist ( Decapeptyl )

Intervention Type DRUG

3 monthly doses of Decapeptyl 7.5mg intramuscular

standard long stimulation protocol

Intervention Type PROCEDURE

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.

1B endometrioma more than 5cm control

Endometrioma aspiration Standard long stimulation protocol \& ICSI

Group Type SHAM_COMPARATOR

endometrioma aspiration

Intervention Type PROCEDURE

Transvaginal ultrasound guided aspiration

standard long stimulation protocol

Intervention Type PROCEDURE

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.

2A endometrioma less than 5cm

Decapeptyl 3.75mg intramuscular Standard long stimulation protocol \& ICSI

Group Type ACTIVE_COMPARATOR

GnRh agonist ( Decapeptyl )

Intervention Type DRUG

3 monthly doses of Decapeptyl 7.5mg intramuscular

standard long stimulation protocol

Intervention Type PROCEDURE

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.

2B endometrioma less than 5cm control

Standard long stimulation protocol \& ICSI

Group Type SHAM_COMPARATOR

standard long stimulation protocol

Intervention Type PROCEDURE

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.

Interventions

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endometrioma aspiration

Transvaginal ultrasound guided aspiration

Intervention Type PROCEDURE

GnRh agonist ( Decapeptyl )

3 monthly doses of Decapeptyl 7.5mg intramuscular

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Other Intervention Names

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Decapeptyl

Eligibility Criteria

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Inclusion Criteria

* endometrioma patients

Exclusion Criteria

* Follicle stimulating hormone(FSH)10 or more
* hydrosalpinx
* GnRh suppression in the last 12 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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suzy abdelaziz Abdelhamid

lecturer of obgyn.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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suzy abdelaziz, lecturer

Role: PRINCIPAL_INVESTIGATOR

Kasr El Aini Hospital

Locations

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Kasrelaini Hospital

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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obgynivf

Identifier Type: -

Identifier Source: org_study_id

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