Menu
Recruiting NCT02948972

Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility

No phase Interventional Endometriosis Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: complete surgery, In vitro fertilization without surgery.
Who it may be relevant to
Registry conditions: Endometriosis, Infertility. Basic parameters: 18 years — 38 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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)

Interventions

  • Procedure complete surgery
    complete surgery of colorectal deep infiltrating endometriosis
  • Procedure In vitro fertilization without surgery
    IVF without endometriosis surgery

Primary outcome measures

  • Clinical pregnancy after 2 IVF cycles [Time frame: At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)]
Secondary outcome measures (11)
  • predictive factors [Time frame: At the end of the 2nd IVF cycle]
  • Clinical pregnancy rate after 1st IVF cycle [Time frame: At the end of the 1st IVF cycle (therefore at 6 weeks after each embryo transfer)]
  • Clinical pregnancy rate per embryo transferred [Time frame: At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)]
  • The IVF complication [Time frame: 24 months after surgery or inclusion in "IVF without surgery" group]
  • perioperative complications [Time frame: 24 months after surgery]
  • The cumulative IVF cycle cancellation rate [Time frame: At the end of the 2nd IVF cycle]
  • Endometriosis Health Profile -5 (short form / EHP5) [Time frame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group]
  • Gastrointestinal Quality of Life Index. (GIQLI) [Time frame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group]
  • Short Form (36) Health Survey _ SF 36 [Time frame: 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 [Time frame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group]
  • Knowles Eccersley Scott Symptom (KESS) score [Time frame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 5 centers
  • CHU — Clermont-Ferrand
  • Hôpital Jeanne de Flandres, CHRU — Lille
  • AP-HP, Hôpital Tenon — Paris
  • CHU — Poissy
  • CHU — Rouen

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. PMID 29097291

Identifiers

NCT: NCT02948972 · 2015_02 · 2015 A01536-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗