NCT02948972 - Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility | Crick

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Endometriosis Infertility

Interventions

complete surgeryPROCEDURE

complete surgery of colorectal deep infiltrating endometriosis

In vitro fertilization without surgeryPROCEDURE

IVF without endometriosis surgery

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 38 Years

Medical Language ↔ Plain English

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

Locations (5)

CHU

Clermont-Ferrand, France

RECRUITING

Hôpital Jeanne de Flandres, CHRU

Lille, France

RECRUITING

AP-HP, Hôpital Tenon

Paris, France

RECRUITING

Outcomes

Primary Outcomes

Clinical pregnancy after 2 IVF cycles

Clinical pregnancy is defined as pregnancy at 6 weeks of gestation with ultrasound echographic confirmation. An IVF cycle is defined as the transfer of all the embryos created via IVF after 1 oocytes puncture until a pregnancy confirmation or until the failure of the last embryo transfer. 2 embryos are transferred for each transfer steps. The length of one cycle depend on the number of embryo transfer steps. It is usually between 2 and 9 months.

Time frame: At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)

Secondary Outcomes

predictive factors

The expected predictive factors observed according to the fecundity status after 2 IVF cycles An IVF cycle is defined as the transfer of all the embryos created via IVF after 1 oocytes puncture until a pregnancy confirmation or until the failure of the last embryo transfer. 2 embryos are transferred for each transfer steps. The length of one cycle depend on the number of embryo transfer steps. It is usually between 2 and 9 months.

Time frame: At the end of the 2nd IVF cycle

Clinical pregnancy rate after 1st IVF cycle

Clinical pregnancy is defined as pregnancy at 6 weeks of gestation with ultrasound echographic confirmation. An IVF cycle is defined as the transfer of all the embryos created via IVF after 1 oocytes puncture until a pregnancy confirmation or until the failure of the last embryo transfer. 2 embryos are transferred for each transfer steps. The length of one cycle depend on the number of embryo transfer steps. It is usually between 2 and 9 months.

Time frame: At the end of the 1st IVF cycle (therefore at 6 weeks after each embryo transfer)

Clinical pregnancy rate per embryo transferred

Clinical pregnancy is defined as pregnancy at 6 weeks of gestation with ultrasound echographic confirmation. An IVF cycle is defined as the transfer of all the embryos created via IVF after 1 oocytes puncture until a pregnancy confirmation or until the failure of the last embryo transfer. 2 embryos are transferred for each transfer steps. The length of one cycle depend on the number of embryo transfer steps. It is usually between 2 and 9 months.

Central Contacts

Pierre Collinet, MD,PhD

CONTACT

+33 320444676 pierre.collinet@chru-lille.fr