NCT04233983

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

January 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

11 months

First QC Date

January 13, 2020

Last Update Submit

January 16, 2020

Conditions

Endometriosis Related Infertility

Keywords

EndometriosisLaparoscopyInfertilityOvarian ReserveEndometrioma

Outcome Measures

Primary Outcomes (1)

  • Positive b-hCG Rate

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

    6 months

Study Arms (2)

Study Group

ACTIVE COMPARATOR

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

Control Group

NO INTERVENTION

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.

Interventions

Laparoscopic Endometriosis SurgeryPROCEDURE

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.

Study Group

Eligibility Criteria

Age23 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uludag University ART Center

Bursa, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 25085800BACKGROUND

  • 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.

    PMID: 29935810RESULT

MeSH Terms

Conditions

EndometriosisInfertility

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gurkan Uncu, Prof.

    Bursa Uludag University School of Medicine ART Center

    STUDY DIRECTOR

Central Study Contacts

Kiper Aslan, M.D

CONTACT

+902242952541kiperaslan@yahoo.com.tr

Isil Kasapoglu, Asc. Prof.

CONTACT

+902242952541kasapogluisil@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective Randomised Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 18, 2020

Study Start

February 1, 2020

Primary Completion

January 1, 2021

Study Completion

March 1, 2021

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)