Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility

Study Overview
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Brief Summary
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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)

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

Conditions
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Endometriosis, Infertility

Intervention / Treatment
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* Procedure: complete surgery
* Procedure: In vitro fertilization without surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: complete surgery<br>Prior surgery 3 months before IVF followup 1, 6 12 and 24 month after surgery | Procedure: complete surgery<br>* complete surgery of colorectal deep infiltrating endometriosis<br>Procedure: In vitro fertilization without surgery<br>* IVF without endometriosis surgery<br>|
| Active Comparator: In vitro fertilization without surgery<br>IVF without endometriosis surgery follow up 6, 12 and 24 month after inclusion. | Procedure: In vitro fertilization without surgery<br>* IVF without endometriosis surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer) | 
| The IVF complication | rate of hyperstimulation, superinfection, worsening of pain and hospitalization related to IVF procedures in each group. | 24 months after surgery or inclusion in IVF without surgery group | 
| perioperative complications | Complications rate of perioperative surgical excision according to the CLAVIEN-DINDO grading system and to the Comprehensive Complication Index | 24 months after surgery | 
| The cumulative IVF cycle cancellation rate | 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. | At the end of the 2nd IVF cycle | 
| Endometriosis Health Profile -5 (short form / EHP5) | Evolution of quality life scores in each group | during inclusion, 6, 12 and 24 months after surgery or inclusion in IVF without surgery group | 
| Gastrointestinal Quality of Life Index. (GIQLI) | Evolution of quality life scores in each group | during inclusion, 6, 12 and 24 months after surgery or inclusion in IVF without surgery group | 
| Short Form (36) Health Survey _ SF 36 | Evolution of quality life scores in each group | 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 | 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 | during inclusion, 6, 12 and 24 months after surgery or inclusion in IVF without surgery group | 
| Knowles Eccersley Scott Symptom (KESS) score | Evolution of the bowel function score KESS | during inclusion, 6, 12 and 24 months after surgery or inclusion in IVF without surgery group | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep infiltrating endometriosis, endometriosis surgery, In vitro fertilization