Endometriosis, Infertility
Conditions
Keywords
deep infiltrating endometriosis, endometriosis surgery, In vitro fertilization
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)
Interventions
PROCEDUREcomplete surgery
complete surgery of colorectal deep infiltrating endometriosis
PROCEDUREIn vitro fertilization without surgery
IVF without endometriosis surgery
Sponsors
University Hospital, Lille
Ministry of Health, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy after 2 IVF cycles | At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| predictive factors | At the end of the 2nd IVF cycle | 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. |
| Clinical pregnancy rate after 1st IVF cycle | At the end of the 1st IVF cycle (therefore at 6 weeks after each embryo transfer) | 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. |
| Clinical pregnancy rate per embryo transferred | At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer) | 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. |
| The IVF complication | 24 months after surgery or inclusion in "IVF without surgery" group | rate of hyperstimulation, superinfection, worsening of pain and hospitalization related to IVF procedures in each group. |
| perioperative complications | 24 months after surgery | Complications rate of perioperative surgical excision according to the CLAVIEN-DINDO grading system and to the Comprehensive Complication Index |
| The cumulative IVF cycle cancellation rate | At the end of the 2nd IVF cycle | The cumulative IVF cycle cancellation rate in each group. 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. |
| Endometriosis Health Profile -5 (short form / EHP5) | during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group | Evolution of quality life scores in each group |
| Gastrointestinal Quality of Life Index. (GIQLI) | during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group | Evolution of quality life scores in each group |
| Short Form (36) Health Survey _ SF 36 | during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group | Evolution of quality life scores in each group |
| Evaluation of hemorrhagic, digestive, urinary symptoms Dysmenorrhea and pains not related to menstruation | during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group | * Dysmenorrhea and pains not related to menstruation will be evaluated by Visual Analog Scale (VAS) * Evolution of the hemorrhagic, digestive and urinary symptoms at 6, 12 and 24 months |
| Knowles Eccersley Scott Symptom (KESS) score | during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group | Evolution of the bowel function score KESS |
Countries
France
Contacts
CONTACTPierre Collinet, MD,PhD
PRINCIPAL_INVESTIGATORPierre Collinet, MD, PhD
University Hospital, Lille
Outcome results
None listed