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

Primary Purpose

Endometriosis Related Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Laparoscopic Endometriosis Surgery
Sponsored by
Uludag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis Related Infertility focused on measuring Endometriosis, Laparoscopy, Infertility, Ovarian Reserve, Endometrioma

Eligibility Criteria

23 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Uludag University ART Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Study Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Positive b-hCG Rate
Postoperative 6. months positive b-hCG rates will be compared with control group.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2020
Last Updated
January 16, 2020
Sponsor
Uludag University
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1. Study Identification

Unique Protocol Identification Number
NCT04233983
Brief Title
Surgery Before Embryo Transfer in ERROR (Endometrioma Related Reduction in Ovarian Reserve)
Official Title
Surgery Before Embryo Transfer in Endometrioma Related Reduction in Ovarian Reserve
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uludag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis Related Infertility
Keywords
Endometriosis, Laparoscopy, Infertility, Ovarian Reserve, Endometrioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomised Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Endometriosis Surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Positive b-hCG Rate
Description
Postoperative 6. months positive b-hCG rates will be compared with control group.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kiper Aslan, M.D
Phone
+902242952541
Email
kiperaslan@yahoo.com.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Isil Kasapoglu, Asc. Prof.
Phone
+902242952541
Email
kasapogluisil@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gurkan Uncu, Prof.
Organizational Affiliation
Bursa Uludag University School of Medicine ART Center
Official's Role
Study Director
Facility Information:
Facility Name
Uludag University ART Center
City
Bursa
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25085800
Citation
Muzii L, Di Tucci C, Di Feliciantonio M, Marchetti C, Perniola G, Panici PB. The effect of surgery for endometrioma on ovarian reserve evaluated by antral follicle count: a systematic review and meta-analysis. Hum Reprod. 2014 Oct 10;29(10):2190-8. doi: 10.1093/humrep/deu199. Epub 2014 Aug 1.
Results Reference
background
PubMed Identifier
29935810
Citation
Kasapoglu I, Ata B, Uyaniklar O, Seyhan A, Orhan A, Yildiz Oguz S, Uncu G. Endometrioma-related reduction in ovarian reserve (ERROR): a prospective longitudinal study. Fertil Steril. 2018 Jul 1;110(1):122-127. doi: 10.1016/j.fertnstert.2018.03.015. Epub 2018 Jun 20.
Results Reference
result

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

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