NCT02737800

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

1.3 years

First QC Date

March 31, 2016

Last Update Submit

July 27, 2018

Conditions

Endometrioma

Outcome Measures

Primary Outcomes (1)

  • Number of patients with urine pregnancy test positive 2 weeks after embryo transfer

    5 months

Study Arms (4)

1A endometrioma more than 5cm

ACTIVE COMPARATOR

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

Procedure: endometrioma aspirationDrug: GnRh agonist ( Decapeptyl )Procedure: standard long stimulation protocol

1B endometrioma more than 5cm control

SHAM COMPARATOR

Endometrioma aspiration Standard long stimulation protocol \& ICSI

Procedure: endometrioma aspirationProcedure: standard long stimulation protocol

2A endometrioma less than 5cm

ACTIVE COMPARATOR

Decapeptyl 3.75mg intramuscular Standard long stimulation protocol \& ICSI

Drug: GnRh agonist ( Decapeptyl )Procedure: standard long stimulation protocol

2B endometrioma less than 5cm control

SHAM COMPARATOR

Standard long stimulation protocol \& ICSI

Procedure: standard long stimulation protocol

Interventions

endometrioma aspirationPROCEDURE

Transvaginal ultrasound guided aspiration

1A endometrioma more than 5cm1B endometrioma more than 5cm control
GnRh agonist ( Decapeptyl )DRUG

3 monthly doses of Decapeptyl 7.5mg intramuscular

Also known as: Decapeptyl
1A endometrioma more than 5cm2A endometrioma less than 5cm
standard long stimulation protocolPROCEDURE

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.

1A endometrioma more than 5cm1B endometrioma more than 5cm control2A endometrioma less than 5cm2B endometrioma less than 5cm control

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • endometrioma patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasrelaini Hospital

Giza, Egypt

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Gonadotropin-Releasing HormoneTriptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • suzy abdelaziz, lecturer

    Kasr El Aini Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obgyn.

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 14, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

July 31, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)