NCT04610710

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.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
terminated

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

October 22, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
26 days until next milestone

Study Start

First participant enrolled

November 25, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2025

Enrollment Period

5.3 years

First QC Date

October 22, 2020

Last Update Submit

March 7, 2026

Conditions

Deep EndometriosisInfertility, Female

Outcome Measures

Primary Outcomes (2)

  • Cumulative pregnancy rate (CPR)

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

    18 months

  • Live birth rate (LBR)

    Rate of live births

    18 months

Secondary Outcomes (12)

  • Non-viable pregnancies

    18 months

  • Ovarian potential

    Baseline and 9-18 months

  • Time to pregnancy

    18 months

  • Postoperative complications

    18 months

  • Fertility treatment complications

    18 months

  • +7 more secondary outcomes

Study Arms (2)

Operation

ACTIVE COMPARATOR

Operation for severe endometriosis

Procedure: Operation

Fertility treatment

ACTIVE COMPARATOR

Fertility treatment for women with severe endometriosis.

Procedure: Fertility treatment

Interventions

OperationPROCEDURE

Operation for deep infiltrating endometriosis

Operation
Fertility treatmentPROCEDURE

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

Fertility treatment

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aarhus University Hospital

Aarhus N, Central Region, 8200, Denmark

Location

Horsens Regional Hospital

Horsens, Central Region, 8700, Denmark

Location

The Endometriosis Center, Clinique Tivoli-Ducos

Bordeaux, France

Location

Related Publications (1)

  • 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.

    PMID: 35410921DERIVED

MeSH Terms

Conditions

Infertility, Female

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trail (RCT)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 30, 2020

Study Start

November 25, 2020

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

March 10, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)FR(1)