Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Operation on Fertility for Women With Severe Endometriosis (EFFORT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04610710
Recruitment Status : Recruiting
First Posted : October 30, 2020
Last Update Posted : October 30, 2020
Sponsor:
Collaborators:
Aarhus University Hospital
Clinique Tivoli Ducos
Information provided by (Responsible Party):
Ulla Breth Knudsen, Horsens Hospital

Brief Summary:
The EFFORT study compares the impact on fertility of operation or fertility treatment (IVF, in vitro fertilization) in a multicenter randomized controlled trial. The study population consists of women with colorectal deep infiltrating endometriosis and a pregnancy intention. These women will be randomized to either of the two treatment groups: Group A = Operation or Group B = fertility treatment (IVF). Group A will be further divided postoperatively into spontaneous conception or IVF depending on the Endometriosis Fertility Index score.

Condition or disease Intervention/treatment Phase
Deep Endometriosis Infertility, Female Procedure: Operation Procedure: Fertility treatment Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Clinical Trail (RCT)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Impact of Operation and Fertility Treatment on Fertility for Women With Deep Infiltrating Endometriosis: A Multicenter Randomized Controlled Trial
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Active Comparator: Operation
Operation for severe endometriosis
Procedure: Operation
Operation for deep infiltrating endometriosis

Active Comparator: Fertility treatment
Fertility treatment for women with severe endometriosis.
Procedure: Fertility treatment
In vitro fertilisation (IVF) and IVF-intracytoplasmic injection (ICSI)




Primary Outcome Measures :
  1. Cumulative pregnancy rate [ Time Frame: 18 months ]
    Rate of cumulative pregnancies defined as viable pregnancies at gestational age 6-8 within the 18 months´ follow-up period

  2. Live birth rate (LBR) [ Time Frame: 18 months ]
    Rate live births


Secondary Outcome Measures :
  1. Non-viable pregnancies [ Time Frame: 18 months ]
    Number biochemical pregnancies, pregnancies of unknown location (PUL), extrauterine pregnancies, miscarriages

  2. Ovarian potential [ Time Frame: Baseline, 9 -18 month ]
    Concentration of Anti-Müllerian hormone (AMH)

  3. Time to pregnancy [ Time Frame: 18 months ]
    Shortest time from intervention to the first ongoing pregnancy

  4. Perioperative complications [ Time Frame: 18 months ]
    Rate of complications in accordance to Clavien-Dindo Classification

  5. Fertility treatment complications [ Time Frame: 18 months ]
    Rate of hospital admissions, superinfection, worsening of pain or having ovarian hyperstimulation syndrome (OHSS)

  6. Pain score [ Time Frame: Baseline, 9 and 18 months ]
    Visual analog score (VAS) from 1 to 10, where 10 implies the worst pain

  7. Quality of life [ Time Frame: Baseline, 9 and 18 months ]
    Development in Endometriosis health profile (EHP-30+23)

  8. Bowel function [ Time Frame: Baseline, 9 and 18 months ]
    Development in bowel function rated by Low anterior resection syndrome (LARS) score

  9. Urinary tract function [ Time Frame: Baseline, 9 and 18 months ]
    Development in urinary tract function rated by International Consultation on Incontinence Questionnaire (ICIQ- FLUTS)

  10. Endometriosis inflammatory status [ Time Frame: Baseline and 18 months ]
    Concentrations of inflammatory markers in blood samples



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rectosigmoid endometriosis and wish for surgery
  • Pregnancy intention for at least 6 months
  • AMH above 5 pmol/ml
  • Maximum of 2 previous IVF treatments
  • Male partner

Exclusion Criteria:

  • Endometriosis involving the ureter unilaterally or bilaterally (randomization unethical)
  • BMI above 32
  • Contraindication for IVF (untreated uterine factor infertility, untreated/maltreated systemic or malignant disease, oocyte aspiration severely riskful (e.g. severe abdominal adhesions)
  • No wish for randomization

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): NCT04610710


Contacts
Layout table for location contacts
Contact: Ulla B Knudsen, Professor +45 78426592 ubk@dadlnet.dk
Contact: Maja Raos majaraos@clin.au.dk

Locations
Layout table for location information
Denmark
Aarhus University Hospital Recruiting
Aarhus N, Central Region, Denmark, 8200
Contact: Mikkel Seyer-Hansen, MD         
Horsens Regional Hospital Recruiting
Horsens, Central Region, Denmark, 8700
Contact: Ulla B Knudsen, Professor    +45 7842 6592    ubk@dadlnet.dk   
France
The Endometriosis Center, Clinique Tivoli-Ducos Recruiting
Bordeaux, France
Contact: Horace Roman, MD         
Sponsors and Collaborators
Horsens Hospital
Aarhus University Hospital
Clinique Tivoli Ducos
Layout table for additonal information
Responsible Party: Ulla Breth Knudsen, Professor, Horsens Hospital
ClinicalTrials.gov Identifier: NCT04610710    
Other Study ID Numbers: Horsens MR
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Endometriosis
Infertility, Female