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

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: Recruiting
• Conditions: Infertility; Endometriosis
• Intervention / Treatment: Procedure: complete surgery; Procedure: In vitro fertilization without surgery

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre Collinet, MD,PhD; Phone Number: +33 +33 320444676; Email: pierre.collinet@chru-lille.fr

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy after 2 IVF cycles	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

Outcome Measure	Measure Description	Time Frame
predictive factors	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	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	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	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	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	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)	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)	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	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	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	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

• Sponsor: University Hospital, Lille
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Pierre Collinet, MD, PhD, University Hospital, Lille

Publications and helpful links

General Publications

• Ledu N, Rubod C, Piessen G, Roman H, Collinet P. Management of deep infiltrating endometriosis of the rectum: Is a systematic temporary stoma relevant? J Gynecol Obstet Hum Reprod. 2018 Jan;47(1):1-7. doi: 10.1016/j.jogoh.2017.10.005. Epub 2017 Oct 31.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2016
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 4, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (Estimated): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: In vitro fertilization; endometriosis surgery; deep infiltrating endometriosis
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Infertility; Endometriosis; Investigative Techniques; Therapeutics; Reproductive Techniques, Assisted; Reproductive Techniques; Surgical Procedures, Operative; Fertilization in Vitro
• Other Study ID 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