Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility

Infertility Clinical Trial

— ENDOFERT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02948972
• Other study ID #: 2015_02
• Secondary ID: 2015 A01536-43
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2016
• Est. completion date: May 2025

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: Pierre Collinet, MD,PhD
• Phone: +33 320444676
• Email: pierre.collinet[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Endometriosis
• Infertility

Intervention

Procedure:
• complete surgery
complete surgery of colorectal deep infiltrating endometriosis
• In vitro fertilization without surgery
IVF without endometriosis surgery

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

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