RecruitingNot ApplicableNCT02948972

Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility

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


Sponsor

University Hospital, Lille

Enrollment

120 participants

Start Date

Nov 17, 2016

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 38 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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

Interventions

PROCEDUREcomplete surgery

complete surgery of colorectal deep infiltrating endometriosis

PROCEDUREIn vitro fertilization without surgery

IVF without endometriosis surgery


Locations(5)

CHU

Clermont-Ferrand, France

Hôpital Jeanne de Flandres, CHRU

Lille, France

AP-HP, Hôpital Tenon

Paris, France

CHU

Poissy, France

CHU

Rouen, France

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NCT02948972


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