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Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility (ENDOFERT)

Primary Purpose

Endometriosis, Infertility

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
complete surgery
In vitro fertilization without surgery
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring deep infiltrating endometriosis, endometriosis surgery, In vitro fertilization

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHURecruiting
  • Hôpital Jeanne de Flandres, CHRURecruiting
  • AP-HP, Hôpital TenonRecruiting
  • CHURecruiting
  • CHURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

complete surgery

In vitro fertilization without surgery

Arm Description

Prior surgery 3 months before IVF followup 1, 6 12 and 24 month after surgery

IVF without endometriosis surgery follow up 6, 12 and 24 month after inclusion.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
The IVF complication
rate of hyperstimulation, superinfection, worsening of pain and hospitalization related to IVF procedures in each group.
perioperative complications
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
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)
Evolution of quality life scores in each group
Gastrointestinal Quality of Life Index. (GIQLI)
Evolution of quality life scores in each group
Short Form (36) Health Survey _ SF 36
Evolution of quality life scores in each 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
Knowles Eccersley Scott Symptom (KESS) score
Evolution of the bowel function score KESS

Full Information

First Posted
October 4, 2016
Last Updated
September 8, 2020
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT02948972
Brief Title
Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility
Acronym
ENDOFERT
Official Title
Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility: Complete Surgery + IVF Versus IVF (ENDOFERT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2016 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Infertility
Keywords
deep infiltrating endometriosis, endometriosis surgery, In vitro fertilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
complete surgery
Arm Type
Experimental
Arm Description
Prior surgery 3 months before IVF followup 1, 6 12 and 24 month after surgery
Arm Title
In vitro fertilization without surgery
Arm Type
Active Comparator
Arm Description
IVF without endometriosis surgery follow up 6, 12 and 24 month after inclusion.
Intervention Type
Procedure
Intervention Name(s)
complete surgery
Intervention Description
complete surgery of colorectal deep infiltrating endometriosis
Intervention Type
Procedure
Intervention Name(s)
In vitro fertilization without surgery
Intervention Description
IVF without endometriosis surgery
Primary Outcome Measure Information:
Title
Clinical pregnancy after 2 IVF cycles
Description
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.
Time Frame
At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)
Secondary Outcome Measure Information:
Title
predictive factors
Description
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.
Time Frame
At the end of the 2nd IVF cycle
Title
Clinical pregnancy rate after 1st IVF cycle
Description
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.
Time Frame
At the end of the 1st IVF cycle (therefore at 6 weeks after each embryo transfer)
Title
Clinical pregnancy rate per embryo transferred
Description
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.
Time Frame
At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)
Title
The IVF complication
Description
rate of hyperstimulation, superinfection, worsening of pain and hospitalization related to IVF procedures in each group.
Time Frame
24 months after surgery or inclusion in "IVF without surgery" group
Title
perioperative complications
Description
Complications rate of perioperative surgical excision according to the CLAVIEN-DINDO grading system and to the Comprehensive Complication Index
Time Frame
24 months after surgery
Title
The cumulative IVF cycle cancellation rate
Description
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.
Time Frame
At the end of the 2nd IVF cycle
Title
Endometriosis Health Profile -5 (short form / EHP5)
Description
Evolution of quality life scores in each group
Time Frame
during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Title
Gastrointestinal Quality of Life Index. (GIQLI)
Description
Evolution of quality life scores in each group
Time Frame
during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Title
Short Form (36) Health Survey _ SF 36
Description
Evolution of quality life scores in each group
Time Frame
during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Title
Evaluation of hemorrhagic, digestive, urinary symptoms Dysmenorrhea and pains not related to menstruation
Description
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
Time Frame
during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Title
Knowles Eccersley Scott Symptom (KESS) score
Description
Evolution of the bowel function score KESS
Time Frame
during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Collinet, MD,PhD
Phone
+33 320444676
Ext
+33
Email
pierre.collinet@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Collinet, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel CANIS, MD
Facility Name
Hôpital Jeanne de Flandres, CHRU
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Collinet, MD,PhD
Facility Name
AP-HP, Hôpital Tenon
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcos BALLESTER, MD
Facility Name
CHU
City
Poissy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud FAUCONNIER, MD
Facility Name
CHU
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Horace ROMAN, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility

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