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NCT Number: NCT02948972

Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility

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)

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

complete surgery

Procedure

complete surgery of colorectal deep infiltrating endometriosis

In vitro fertilization without surgery

Procedure

IVF without endometriosis surgery

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre Collinet, MD,PhD

CONTACT

[email protected]

+33 320444676 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: ENDOFERT

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Oct 31, 2016
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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