Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility (ENDOFERT)

University Hospital, Lille

Status: Enrolling

Conditions: Infertility; Endometriosis

Treatments: Procedure: complete surgery; Procedure: In vitro fertilization without surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02948972

2015 A01536-43 (Other Identifier)

2015_02

Details and patient eligibility

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)

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

complete surgery

Experimental group

Description:

Prior surgery 3 months before IVF followup 1, 6 12 and 24 month after surgery

Treatment:

Procedure: In vitro fertilization without surgery

Procedure: complete surgery

In vitro fertilization without surgery

Active Comparator group

Description:

IVF without endometriosis surgery follow up 6, 12 and 24 month after inclusion.

Treatment:

Procedure: In vitro fertilization without surgery