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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02948972
Recruitment Status : Recruiting
First Posted : October 31, 2016
Last Update Posted : June 26, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

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
Endometriosis Infertility Procedure: complete surgery Procedure: In vitro fertilization without surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility: Complete Surgery + IVF Versus IVF (ENDOFERT)
Actual Study Start Date : November 17, 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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




Primary Outcome Measures :
  1. Clinical pregnancy after 2 IVF cycles [ Time Frame: 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 :
  1. predictive factors [ Time Frame: 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.


  2. Clinical pregnancy rate after 1st IVF cycle [ Time Frame: 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.


  3. Clinical pregnancy rate per embryo transferred [ Time Frame: 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.


  4. The IVF complication [ Time Frame: 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.

  5. perioperative complications [ Time Frame: 24 months after surgery ]
    Complications rate of perioperative surgical excision according to the CLAVIEN-DINDO grading system and to the Comprehensive Complication Index

  6. The cumulative IVF cycle cancellation rate [ Time Frame: 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.


  7. Endometriosis Health Profile -5 (short form / EHP5) [ Time Frame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group ]
    Evolution of quality life scores in each group

  8. Gastrointestinal Quality of Life Index. (GIQLI) [ Time Frame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group ]
    Evolution of quality life scores in each group

  9. Short Form (36) Health Survey _ SF 36 [ Time Frame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group ]
    Evolution of quality life scores in each group

  10. Evaluation of hemorrhagic, digestive, urinary symptoms Dysmenorrhea and pains not related to menstruation [ Time Frame: 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

  11. Knowles Eccersley Scott Symptom (KESS) score [ Time Frame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group ]
    Evolution of the bowel function score KESS



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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948972


Contacts
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Contact: Pierre Collinet, MD,PhD +33 320444676 ext +33 pierre.collinet@chru-lille.fr

Locations
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France
CHU Recruiting
Clermont-Ferrand, France
Principal Investigator: Michel CANIS, MD         
Hôpital Jeanne de Flandres, CHRU Recruiting
Lille, France
Principal Investigator: Pierre Collinet, MD,PhD         
AP-HP, Hôpital Tenon Recruiting
Paris, France
Principal Investigator: Marcos BALLESTER, MD         
CHU Recruiting
Poissy, France
Principal Investigator: Arnaud FAUCONNIER, MD         
CHU Recruiting
Rouen, France
Principal Investigator: Horace ROMAN, MD         
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
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Principal Investigator: Pierre Collinet, MD, PhD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02948972    
Other Study ID Numbers: 2015_02
2015 A01536-43 ( Other Identifier: ID-RCB number, ANSM )
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
deep infiltrating endometriosis
endometriosis surgery
In vitro fertilization
Additional relevant MeSH terms:
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Infertility
Endometriosis
Genital Diseases, Male
Genital Diseases, Female