Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015 A01536-43 | Other Identifier | ID-RCB number, ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| complete surgery | Experimental | Prior surgery 3 months before IVF followup 1, 6 12 and 24 month after surgery |
|
| In vitro fertilization without surgery | Active Comparator | IVF without endometriosis surgery follow up 6, 12 and 24 month after inclusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| complete surgery | Procedure | complete surgery of colorectal deep infiltrating endometriosis |
|
| 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) |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre Collinet, MD,PhD | Contact | +33 320444676 | +33 | pierre.collinet@chru-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre Collinet, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Recruiting | Clermont-Ferrand | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29097291 | Result | Ledu N, Rubod C, Piessen G, Roman H, Collinet P. Management of deep infiltrating endometriosis of the rectum: Is a systematic temporary stoma relevant? J Gynecol Obstet Hum Reprod. 2018 Jan;47(1):1-7. doi: 10.1016/j.jogoh.2017.10.005. Epub 2017 Oct 31. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005307 | Fertilization in Vitro |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| In vitro fertilization without surgery | Procedure | IVF without endometriosis surgery |
|
| 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 |
| 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 |
| Hôpital Jeanne de Flandres, CHRU | Recruiting | Lille | France |
|
| AP-HP, Hôpital Tenon | Recruiting | Paris | France |
|
| CHU | Recruiting | Poissy | France |
|
| CHU | Recruiting | Rouen | France |
|
| D000091662 | Genital Diseases |