Surgery Before Embryo Transfer in ERROR (Endometrioma Related Reduction in Ovarian Reserve)

January 16, 2020 updated by: GÜRKAN UNCU,PROF. MD, Uludag University

Surgery Before Embryo Transfer in Endometrioma Related Reduction in Ovarian Reserve

This prospective study evaluates the pregnancy results after laparoscopic endometriosis operation in infertile patients with ERROR (endometrioma related reduction in ovarian reserve)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study consists of two groups. Patients will be randomly enrolled into the groups by ART (assisted reproductive technology) centre nursery. All patients will sign a consent form about procedure.

Patients diagnosed with endometrioma (larger than 3 cm diameter) and ERROR (endometrioma related reduction in ovarian reserve - Antimullerian Hormon < 1.2 ng/ml, Antral follicle count < 7 , Day3 Follicle Stimulating Hormone > 10 IU/dl, Low response to ovarian hyper stimulation < 3 oocytes) will be enrolled in study. Patients with age >40, with male factor, with undefined adnexal mass, malignity suspicion will be excluded from study.

The study group consists of patients who will undergo laparoscopic endometriosis surgery after ICSI procedure with freezing all embryos. The patients will wait about 6 months for spontaneous conception, if there is no pregnancy during this period, frozen embryo transfer will be performed. The control group consists of patients who will be performed IVF&ICSI procedure with fresh embryo transfer without surgery. If there is no pregnancy, patients will be operated then.

As the primary; result positive b-hCG rates will be compared between groups.

In conclusion we will find out whether laparoscopic endometriosis operation improves or worsens the pregnancy results in patients with ERROR.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey
        • Uludag University ART Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Presence of Endometrioma at least in one ovary, larger than 3 cm diameter
  • Endometriosis Related Reduction in Ovarian Reserve (ERROR)
  • Presence of endometriosis related infertility

Exclusion Criteria:

  • Presence of chronic systemic disease
  • Presence of male factor infertility
  • Suspicion of ovarian malignancy or undefined ovarian mass

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study Group
The study group consists of ERROR(endometrioma related reduction in ovarian reserve) patients who will undergo laparoscopic endometriosis surgery after ICSI procedure with freezing all embryos. The patients will wait about 6 months for spontaneous conception, if there is no pregnancy during this period, frozen embryo transfer will be performed.
Procedure: Laparoscopic Endometriosis Surgery
Patient with ERROR(endometrioma related reduction in ovarian reserve), and endometrioma larger than 3 cm diameter will be operated after IVF&ICSI procedure. Operation will be done by senior surgeons of our department. Laparoscopic endometrioma operation procedure consists of excision of endometrioma cyst with its capsule from ovary without using any electric modality to prevent ovarian damage.
No Intervention: Control Group
The control group consists of ERROR(endometrioma related reduction in ovarian reserve) patients who will be performed IVF&ICSI procedure with fresh embryo transfer without surgery. If there is no pregnancy, patients will be operated then.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive b-hCG Rate
Time Frame: 6 months
Postoperative 6. months positive b-hCG rates will be compared with control group.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uludag University

Investigators

  • Study Director: Gurkan Uncu, Prof., Bursa Uludag University School of Medicine ART Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

January 16, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-19/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometriosis Related Infertility

Clinical Trials on Laparoscopic Endometriosis Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe