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

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ClinicalTrials.gov Identifier: NCT02737800
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
suzy abdelaziz Abdelhamid, 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

Condition or disease Intervention/treatment Phase
Endometrioma Procedure: endometrioma aspiration Drug: GnRh agonist ( Decapeptyl ) Procedure: standard long stimulation protocol Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Prolonged GnRh Agonist Therapy on the Outcome of In-Vitro Fertilization& Embryo Transfer in Endometrioma Patients
Actual Study Start Date : April 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1A endometrioma more than 5cm
Endometrioma aspiration GnRh agonist :Decapeptyl 3.75mg intramuscular Standard long stimulation protocol & ICSI
Procedure: endometrioma aspiration
Transvaginal ultrasound guided aspiration

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

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.

Sham Comparator: 1B endometrioma more than 5cm control
Endometrioma aspiration Standard long stimulation protocol & ICSI
Procedure: endometrioma aspiration
Transvaginal ultrasound guided aspiration

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.

Active Comparator: 2A endometrioma less than 5cm
Decapeptyl 3.75mg intramuscular Standard long stimulation protocol & ICSI
Drug: GnRh agonist ( Decapeptyl )
3 monthly doses of Decapeptyl 7.5mg intramuscular
Other Name: Decapeptyl

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.

Sham Comparator: 2B endometrioma less than 5cm control
Standard long stimulation protocol & ICSI
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.




Primary Outcome Measures :
  1. Number of patients with urine pregnancy test positive 2 weeks after embryo transfer [ Time Frame: 5 months ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • endometrioma patients

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737800


Locations
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Egypt
Kasrelaini Hospital
Giza, Egypt
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Principal Investigator: suzy abdelaziz, lecturer Kasr El Aini Hospital

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Responsible Party: suzy abdelaziz Abdelhamid, lecturer of obgyn., Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT02737800     History of Changes
Other Study ID Numbers: obgynivf
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Triptorelin Pamoate
Deslorelin
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents