Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility

NCT ID: NCT02948972

Last Updated: 2025-12-23

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-17

Study Completion Date

2026-05-31

Brief Summary

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The ENDOFERT Study is an open, multicenter, randomized, parallel-group, controlled trial. This study includes patients presenting colorectal DIE and infertility. Patients will be randomized in two parallel-groups; one group underwent complete surgery of colorectal DIE prior to ART and the other group underwent ART alone (ratio 1:1)

Detailed Description

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Conditions

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Endometriosis Infertility

Keywords

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deep infiltrating endometriosis endometriosis surgery In vitro fertilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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complete surgery

Prior surgery 3 months before IVF followup 1, 6 12 and 24 month after surgery

Group Type EXPERIMENTAL

complete surgery

Intervention Type PROCEDURE

complete surgery of colorectal deep infiltrating endometriosis

In vitro fertilization without surgery

Intervention Type PROCEDURE

IVF without endometriosis surgery

In vitro fertilization without surgery

IVF without endometriosis surgery follow up 6, 12 and 24 month after inclusion.

Group Type ACTIVE_COMPARATOR

In vitro fertilization without surgery

Intervention Type PROCEDURE

IVF without endometriosis surgery

Interventions

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complete surgery

complete surgery of colorectal deep infiltrating endometriosis

Intervention Type PROCEDURE

In vitro fertilization without surgery

IVF without endometriosis surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Primary and secondary infertility
* Indication for IVF
* Persistent pain related to endometriosis with analgesic medical treatment failure
* Persistent pain including at least one of the following digestive symptoms related to endometriosis: Dyschesia / Sub-occlusive syndrome / Rectal bleeding / Painful defecation
* Colorectal deep infiltrating endometriosis : Whatever lesion size / With at least rectal serosal involvement / Confirmed by MRI and 1 different investigation: vaginal ultrasound echography or coloscopic CT scan or rectal endoscope ultrasound
* Eligible for DIE surgery

Exclusion Criteria

* Contraindication to pregnancy or to IVF
* Viral risk
* Previous IVF cycle(s)
* Previous colorectal surgery
* Need of myomectomy during surgery
* The use of oocytes donor
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Collinet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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CHU

Clermont-Ferrand, , France

Site Status RECRUITING

Hôpital Jeanne de Flandres, CHRU

Lille, , France

Site Status RECRUITING

AP-HP, Hôpital Tenon

Paris, , France

Site Status RECRUITING

CHU

Poissy, , France

Site Status RECRUITING

CHU

Rouen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre Collinet, MD,PhD

Role: CONTACT

Phone: +33 320444676

Email: [email protected]

Other Identifiers

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2015 A01536-43

Identifier Type: OTHER

Identifier Source: secondary_id

2015_02

Identifier Type: -

Identifier Source: org_study_id