Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility
Recruiting · NCT02948972 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Lille
View the official record on ClinicalTrials.gov →Interventions studied
In vitro fertilization without surgerycomplete surgery
What this trial is about
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)
Who can take part
Age range
18 Years to 38 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
5 locations listed.
- CHU - Clermont-Ferrand, France
- Hôpital Jeanne de Flandres, CHRU - Lille, France
- AP-HP, Hôpital Tenon - Paris, France
- CHU - Poissy, France
- CHU - Rouen, France