Back to results

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

Primary Purpose

Deep Endometriosis, Infertility, Female

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Operation

Fertility treatment

About this trial

This is an interventional treatment trial for Deep Endometriosis

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Aarhus University HospitalRecruiting
Horsens Regional HospitalRecruiting
The Endometriosis Center, Clinique Tivoli-DucosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Operation

Fertility treatment

Arm Description

Operation for severe endometriosis

Fertility treatment for women with severe endometriosis.

Outcomes

Primary Outcome Measures

Cumulative pregnancy rate (CPR)

Rate of cumulative pregnancies defined as a fetal heartbeat by ultrasound at gestational week 6 to 8

Live birth rate (LBR)

Rate of live births

Secondary Outcome Measures

Non-viable pregnancies

Number of biochemical pregnancies, miscarriages, missed abortions, extrauterine pregnancies and pregnancies of unknown location (PUL)

Ovarian potential

Concentration of Anti-Müllerian hormone (AMH)

Time to pregnancy

Shortest time from intervention date to date of visualisation of the first ongoing pregnancy

Postoperative complications

Rate of complications in accordance to Clavien-Dindo Classification, including anastomotic leakage or stenosis, ureteral lesion or obstruction, pelvic abscess, fistula, bladder or bowel perforation and urinary retention

Fertility treatment complications

Rate of hospital admissions, bleeding, superinfection, worsening of pain or having ovarian hyperstimulation syndrome (OHSS)

Pain score

Numeric Rating Scale (NRS) score from 0 to 10, where 10 implies the worst pain

Quality of Life (QoL)

Development in Endometriosis Health Profile (EHP-30+23), including section C (sexual function QoL questions) and section F (fertility QoL questions)

Delayed bowel function

Development in bowel function rated by Low Anterior Resection Syndrome (LARS) score

Delayed bladder function

Development in urinary tract function rated by International Consultation on Incontinence Questionnaire (ICIQ- FLUTS)

Endometriosis hormonal and inflammatory status

Concentrations of hormonal and inflammatory markers in blood samples

Follicles, oocytes, fertilized oocytes, blastocysts, and frozen embryos

Number of follicles as measured at last scan prior to oocyte pick-up (OPU), number of oocytes at OPU, fertilized oocytes, blastocysts and frozen embryos

Blastocyst morphology score

Gardner scoring system, Steer grading system, Veecks criteria, or other scoring systems of blastocyst morphology

Full Information

NCT ID

NCT04610710

First Posted

October 22, 2020

Last Updated

March 2, 2023

Sponsor

Horsens Hospital

Collaborators

Aarhus University Hospital, Clinique Tivoli Ducos

1. Study Identification

Unique Protocol Identification Number

NCT04610710

Brief Title

Impact of Operation on Fertility for Women With Severe Endometriosis

Acronym

EFFORT

Official Title

Comparing Impact of Operation and Fertility Treatment on Fertility for Women With Deep Infiltrating Endometriosis: A Multicenter Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

January 31, 2025 (Anticipated)

Study Completion Date

July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Horsens Hospital

Collaborators

Aarhus University Hospital, Clinique Tivoli Ducos

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deep Endometriosis, Infertility, Female

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized Clinical Trail (RCT)

Masking

None (Open Label)

Allocation

Randomized

Enrollment

352 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Operation

Arm Type

Active Comparator

Arm Description

Operation for severe endometriosis

Arm Title

Fertility treatment

Arm Type

Active Comparator

Arm Description

Fertility treatment for women with severe endometriosis.

Intervention Type

Procedure

Intervention Name(s)

Operation

Intervention Description

Operation for deep infiltrating endometriosis

Intervention Type

Procedure

Intervention Name(s)

Fertility treatment

Intervention Description

In vitro fertilisation (IVF) and IVF-intracytoplasmic injection (ICSI)

Primary Outcome Measure Information:

Title

Cumulative pregnancy rate (CPR)

Description

Rate of cumulative pregnancies defined as a fetal heartbeat by ultrasound at gestational week 6 to 8

Time Frame

18 months

Title

Live birth rate (LBR)

Description

Rate of live births

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Non-viable pregnancies

Description

Number of biochemical pregnancies, miscarriages, missed abortions, extrauterine pregnancies and pregnancies of unknown location (PUL)

Time Frame

18 months

Title

Ovarian potential

Description

Concentration of Anti-Müllerian hormone (AMH)

Time Frame

Baseline and 9-18 months

Title

Time to pregnancy

Description

Shortest time from intervention date to date of visualisation of the first ongoing pregnancy

Time Frame

18 months

Title

Postoperative complications

Description

Time Frame

18 months

Title

Fertility treatment complications

Description

Rate of hospital admissions, bleeding, superinfection, worsening of pain or having ovarian hyperstimulation syndrome (OHSS)

Time Frame

18 months

Title

Pain score

Description

Numeric Rating Scale (NRS) score from 0 to 10, where 10 implies the worst pain

Time Frame

Baseline, 9 and 18 months

Title

Quality of Life (QoL)

Description

Development in Endometriosis Health Profile (EHP-30+23), including section C (sexual function QoL questions) and section F (fertility QoL questions)

Time Frame

Baseline, 9 and 18 months

Title

Delayed bowel function

Description

Development in bowel function rated by Low Anterior Resection Syndrome (LARS) score

Time Frame

Baseline, 9 and 18 months

Title

Delayed bladder function

Description

Development in urinary tract function rated by International Consultation on Incontinence Questionnaire (ICIQ- FLUTS)

Time Frame

Baseline, 9 and 18 months

Title

Endometriosis hormonal and inflammatory status

Description

Concentrations of hormonal and inflammatory markers in blood samples

Time Frame

Baseline and 9-18 months

Title

Follicles, oocytes, fertilized oocytes, blastocysts, and frozen embryos

Description

Number of follicles as measured at last scan prior to oocyte pick-up (OPU), number of oocytes at OPU, fertilized oocytes, blastocysts and frozen embryos

Time Frame

18 months

Title

Blastocyst morphology score

Description

Gardner scoring system, Steer grading system, Veecks criteria, or other scoring systems of blastocyst morphology

Time Frame

18 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ulla B Knudsen, Professor

Phone

+45 78426592

ubk@dadlnet.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Maja Raos

majaraos@clin.au.dk

Facility Information:

Facility Name

Aarhus University Hospital

City

Aarhus N

State/Province

Central Region

ZIP/Postal Code

8200

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mikkel Seyer-Hansen, MD

Facility Name

Horsens Regional Hospital

City

Horsens

State/Province

Central Region

ZIP/Postal Code

8700

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ulla B Knudsen, Professor

Phone

+45 7842 6592

ubk@dadlnet.dk

Facility Name

The Endometriosis Center, Clinique Tivoli-Ducos

City

Bordeaux

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Horace Roman, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35410921

Citation

Raos M, Roman H, Seyer-Hansen M, Kesmodel US, Knudsen UB. EFFORT study: Comparing impact of operation and assisted reproductive technologies on fertility for women with deep infiltrating endometriosis - study protocol for a multicentre randomised trial. BMJ Open. 2022 Apr 11;12(4):e052877. doi: 10.1136/bmjopen-2021-052877.

Results Reference

derived

Learn more about this trial

Impact of Operation on Fertility for Women With Severe Endometriosis

We'll reach out to this number within 24 hrs