ENDOFERT: Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: complete surgery Prior surgery 3 months before IVF followup 1, 6 12 and 24 month after surgery |
Procedure: complete surgery
complete surgery of colorectal deep infiltrating endometriosis
Procedure: In vitro fertilization without surgery
IVF without endometriosis surgery
|
| Active Comparator: In vitro fertilization without surgery IVF without endometriosis surgery follow up 6, 12 and 24 month after inclusion. |
Procedure: In vitro fertilization without surgery
IVF without endometriosis surgery
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU | Clermont-Ferrand | France | ||
| 2 | Hôpital Jeanne de Flandres, CHRU | Lille | France | ||
| 3 | AP-HP, Hôpital Tenon | Paris | France | ||
| 4 | CHU | Poissy | France | ||
| 5 | CHU | Rouen | France |
Sponsors and Collaborators
- University Hospital, Lille
- Ministry of Health, France
Investigators
- Principal Investigator: Pierre Collinet, MD, PhD, University Hospital, Lille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015_02
- 2015 A01536-43