Clinical trial NCT02948972: Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility
Official title: Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility: Complete Surgery + IVF Versus IVF (ENDOFERT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis
Infertility
Keywords: deep infiltrating endometriosis
endometriosis surgery
In vitro fertilization
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2016-10-31
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Clinical pregnancy after 2 IVF cycles
timeFrame: At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)
Secondary outcomes:
measure: predictive factors
timeFrame: At the end of the 2nd IVF cycle
measure: Clinical pregnancy rate after 1st IVF cycle
timeFrame: At the end of the 1st IVF cycle (therefore at 6 weeks after each embryo transfer)
measure: Clinical pregnancy rate per embryo transferred
timeFrame: At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)
measure: The IVF complication
timeFrame: 24 months after surgery or inclusion in "IVF without surgery" group
measure: perioperative complications
timeFrame: 24 months after surgery
measure: The cumulative IVF cycle cancellation rate
timeFrame: At the end of the 2nd IVF cycle
measure: Endometriosis Health Profile -5 (short form / EHP5)
timeFrame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
measure: Gastrointestinal Quality of Life Index. (GIQLI)
timeFrame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
measure: Short Form (36) Health Survey _ SF 36
timeFrame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
measure: Evaluation of hemorrhagic, digestive, urinary symptoms Dysmenorrhea and pains not related to menstruation
timeFrame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
measure: Knowles Eccersley Scott Symptom (KESS) score
timeFrame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU
city: Lille
country: France
facility: Hôpital Jeanne de Flandres, CHRU
city: Paris
country: France
facility: AP-HP, Hôpital Tenon
city: Poissy
country: France
facility: CHU
city: Rouen
country: France
facility: CHU
Study officials:
affiliation: University Hospital, Lille
name: Pierre Collinet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: