Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility (ENDOFERT)

April 17, 2026 updated by: University Hospital, Lille

Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility: Complete Surgery + IVF Versus IVF (ENDOFERT)

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Clermont-Ferrand, France
        • Recruiting
        • CHU
        • Principal Investigator:
          • Michel CANIS, MD
      • Lille, France
        • Recruiting
        • Hôpital Jeanne de Flandres, CHRU
        • Principal Investigator:
          • Pierre Collinet, MD,PhD
      • Paris, France
        • Recruiting
        • AP-HP, Hôpital Tenon
        • Principal Investigator:
          • Marcos BALLESTER, MD
      • Poissy, France
        • Recruiting
        • CHU
        • Principal Investigator:
          • Arnaud FAUCONNIER, MD
      • Rouen, France
        • Recruiting
        • CHU
        • Principal Investigator:
          • Horace ROMAN, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: complete surgery
Prior surgery 3 months before IVF followup 1, 6 12 and 24 month after surgery
Procedure: complete surgery
complete surgery of colorectal deep infiltrating endometriosis
Procedure: In vitro fertilization without surgery
IVF without endometriosis surgery
Active Comparator: In vitro fertilization without surgery
IVF without endometriosis surgery follow up 6, 12 and 24 month after inclusion.
Procedure: In vitro fertilization without surgery
IVF without endometriosis surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical pregnancy after 2 IVF cycles
Time Frame: At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)

Clinical pregnancy is defined as pregnancy at 6 weeks of gestation with ultrasound echographic confirmation.

An IVF cycle is defined as the transfer of all the embryos created via IVF after 1 oocytes puncture until a pregnancy confirmation or until the failure of the last embryo transfer. 2 embryos are transferred for each transfer steps.

The length of one cycle depend on the number of embryo transfer steps. It is usually between 2 and 9 months.
At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
predictive factors
Time Frame: At the end of the 2nd IVF cycle

The expected predictive factors observed according to the fecundity status after 2 IVF cycles

An IVF cycle is defined as the transfer of all the embryos created via IVF after 1 oocytes puncture until a pregnancy confirmation or until the failure of the last embryo transfer. 2 embryos are transferred for each transfer steps.

The length of one cycle depend on the number of embryo transfer steps. It is usually between 2 and 9 months.
At the end of the 2nd IVF cycle
Clinical pregnancy rate after 1st IVF cycle
Time Frame: At the end of the 1st IVF cycle (therefore at 6 weeks after each embryo transfer)

Clinical pregnancy is defined as pregnancy at 6 weeks of gestation with ultrasound echographic confirmation.

An IVF cycle is defined as the transfer of all the embryos created via IVF after 1 oocytes puncture until a pregnancy confirmation or until the failure of the last embryo transfer. 2 embryos are transferred for each transfer steps.

The length of one cycle depend on the number of embryo transfer steps. It is usually between 2 and 9 months.
At the end of the 1st IVF cycle (therefore at 6 weeks after each embryo transfer)
Clinical pregnancy rate per embryo transferred
Time Frame: At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)

Clinical pregnancy is defined as pregnancy at 6 weeks of gestation with ultrasound echographic confirmation.

An IVF cycle is defined as the transfer of all the embryos created via IVF after 1 oocytes puncture until a pregnancy confirmation or until the failure of the last embryo transfer. 2 embryos are transferred for each transfer steps.

The length of one cycle depend on the number of embryo transfer steps. It is usually between 2 and 9 months.
At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)
The IVF complication
Time Frame: 24 months after surgery or inclusion in "IVF without surgery" group
rate of hyperstimulation, superinfection, worsening of pain and hospitalization related to IVF procedures in each group.
24 months after surgery or inclusion in "IVF without surgery" group
perioperative complications
Time Frame: 24 months after surgery
Complications rate of perioperative surgical excision according to the CLAVIEN-DINDO grading system and to the Comprehensive Complication Index
24 months after surgery
The cumulative IVF cycle cancellation rate
Time Frame: At the end of the 2nd IVF cycle

The cumulative IVF cycle cancellation rate in each group.

An IVF cycle is defined as the transfer of all the embryos created via IVF after 1 oocytes puncture until a pregnancy confirmation or until the failure of the last embryo transfer. 2 embryos are transferred for each transfer steps.

The length of one cycle depend on the number of embryo transfer steps. It is usually between 2 and 9 months.
At the end of the 2nd IVF cycle
Endometriosis Health Profile -5 (short form / EHP5)
Time Frame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Evolution of quality life scores in each group
during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Gastrointestinal Quality of Life Index. (GIQLI)
Time Frame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Evolution of quality life scores in each group
during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Short Form (36) Health Survey _ SF 36
Time Frame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Evolution of quality life scores in each group
during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Evaluation of hemorrhagic, digestive, urinary symptoms Dysmenorrhea and pains not related to menstruation
Time Frame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
  • Dysmenorrhea and pains not related to menstruation will be evaluated by Visual Analog Scale (VAS)
  • Evolution of the hemorrhagic, digestive and urinary symptoms at 6, 12 and 24 months
during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Knowles Eccersley Scott Symptom (KESS) score
Time Frame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Evolution of the bowel function score KESS
during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre Collinet, MD, PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015_02
  • 2015 A01536-43 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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