Complete colorectal deep infiltrating endometriosis surgery before IVF to improve fertility
Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility: Complete Surgery + IVF Versus IVF (ENDOFERT)
This trial tests whether having complete surgery for colorectal deep infiltrating endometriosis before in vitro fertilization (IVF) helps women with endometriosis and infertility get pregnant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 38 Years |
| Sex | Female |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 5 sites (Clermont-Ferrand and 4 other locations) |
| Trial ID | NCT02948972 on ClinicalTrials.gov |
What this trial studies
ENDO FERT is an open, multicenter, randomized parallel-group trial enrolling people with colorectal deep infiltrating endometriosis (DIE) who have infertility and an indication for IVF. Participants are randomized 1:1 to either undergo complete colorectal DIE surgery before assisted reproductive technology (ART) or to proceed with ART alone. Eligibility requires MRI-confirmed colorectal DIE with at least rectal serosal involvement and persistent pain or digestive symptoms, and excludes those with prior colorectal surgery or previous IVF cycles. The main outcomes focus on fertility results after the assigned approach, comparing pregnancy and related reproductive endpoints between groups.
Who should consider this trial
Good fit: Ideal candidates are women with primary or secondary infertility, MRI-confirmed colorectal deep infiltrating endometriosis with rectal serosal involvement, persistent pain or digestive symptoms, and who are eligible for DIE surgery and have an indication for IVF.
Not a fit: Patients with contraindications to pregnancy or IVF, prior colorectal surgery, previous IVF cycles, a need for myomectomy during surgery, viral risk, or who require oocyte donation are not expected to benefit from this trial.
Why it matters
Potential benefit: If successful, doing complete colorectal DIE surgery before IVF could increase the chances of pregnancy and live birth for people with this form of endometriosis.
How similar studies have performed: Evidence is limited and mixed: observational studies suggest surgery can improve spontaneous fertility in some endometriosis patients, but randomized data specifically addressing colorectal DIE before IVF are scarce.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Clermont-Ferrand and 4 other locations
- Chu — Clermont-Ferrand, France (Recruiting)
- Hôpital Jeanne de Flandres, CHRU — Lille, France (Recruiting)
- AP-HP, Hôpital Tenon — Paris, France (Recruiting)
- Chu — Poissy, France (Recruiting)
- Chu — Rouen, France (Recruiting)
Study contacts
- Principal investigator: Pierre Collinet, MD, PhD — University Hospital, Lille
- Study coordinator: Pierre Collinet, MD,PhD
- Email: pierre.collinet@chru-lille.fr
- Phone: +33 320444676
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.