Infertility Clinical Trial
— ENDOFERTOfficial title:
Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility: Complete Surgery + IVF Versus IVF (ENDOFERT)
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)
Status | Recruiting |
Enrollment | 120 |
Est. completion date | May 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 38 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU | Clermont-Ferrand | |
France | Hôpital Jeanne de Flandres, CHRU | Lille | |
France | AP-HP, Hôpital Tenon | Paris | |
France | CHU | Poissy | |
France | CHU | Rouen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille | Ministry of Health, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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