Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility
ENDOFERT
2 other identifiers
interventional
120
1 country
5
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2016
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2016
CompletedFirst Posted
Study publicly available on registry
October 31, 2016
CompletedStudy Start
First participant enrolled
November 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedApril 22, 2026
April 1, 2026
9.5 years
October 4, 2016
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
predictive factors
At the end of the 2nd IVF cycle
Clinical pregnancy rate after 1st IVF cycle
At the end of the 1st IVF cycle (therefore at 6 weeks after each embryo transfer)
Clinical pregnancy rate per embryo transferred
At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)
The IVF complication
24 months after surgery or inclusion in "IVF without surgery" group
perioperative complications
24 months after surgery
- +6 more secondary outcomes
Study Arms (2)
complete surgery
EXPERIMENTALPrior surgery 3 months before IVF followup 1, 6 12 and 24 month after surgery
In vitro fertilization without surgery
ACTIVE COMPARATORIVF without endometriosis surgery follow up 6, 12 and 24 month after inclusion.
Interventions
complete surgery of colorectal deep infiltrating endometriosis
IVF without endometriosis surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Lillelead
- Ministry of Health, Francecollaborator
Study Sites (5)
CHU
Clermont-Ferrand, France
Hôpital Jeanne de Flandres, CHRU
Lille, France
AP-HP, Hôpital Tenon
Paris, France
CHU
Poissy, France
CHU
Rouen, France
Related Publications (1)
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.
PMID: 29097291RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Collinet, MD, PhD
University Hospital, Lille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2016
First Posted
October 31, 2016
Study Start
November 17, 2016
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share