Impact of Operation on Fertility for Women with Severe Endometriosis

NCT ID: NCT04610710

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2035-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Deep Endometriosis Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Clinical Trail (RCT)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Operation

Operation for severe endometriosis

Group Type ACTIVE_COMPARATOR

Operation

Intervention Type PROCEDURE

Operation for deep infiltrating endometriosis

Fertility treatment

Fertility treatment for women with severe endometriosis.

Group Type ACTIVE_COMPARATOR

Fertility treatment

Intervention Type PROCEDURE

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

Interventions

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Operation

Operation for deep infiltrating endometriosis

Intervention Type PROCEDURE

Fertility treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Clinique Tivoli Ducos

OTHER

Sponsor Role collaborator

Horsens Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ulla Breth Knudsen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aarhus University Hospital

Aarhus N, Central Region, Denmark

Site Status RECRUITING

Horsens Regional Hospital

Horsens, Central Region, Denmark

Site Status RECRUITING

The Endometriosis Center, Clinique Tivoli-Ducos

Bordeaux, , France

Site Status RECRUITING

Countries

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Denmark France

Central Contacts

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Ulla B Knudsen, Professor

Role: CONTACT

+45 78426592

Maja Raos

Role: CONTACT

Facility Contacts

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Mikkel Seyer-Hansen, MD

Role: primary

Ulla B Knudsen, Professor

Role: primary

+45 7842 6592

Horace Roman, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35410921 (View on PubMed)

Other Identifiers

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Horsens MR

Identifier Type: -

Identifier Source: org_study_id

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