EndometriosisENDOFERTNCT02948972
Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility
A study testing complete surgery and In vitro fertilization without surgery in people with Endometriosis and Infertility, run by University Hospital, Lille at 5 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Endometriosis, Infertility
- What is being tested?
- complete surgery and In vitro fertilization without surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesFrance
- Study dates
- 17 Nov 2016to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU
Clermont-Ferrand
Michel CANIS, MD
- Recruiting
Hôpital Jeanne de Flandres, CHRU
Lille
Pierre Collinet, MD,PhD
- Recruiting
AP-HP, Hôpital Tenon
Paris
Marcos BALLESTER, MD
- Recruiting
CHU
Poissy
Arnaud FAUCONNIER, MD
- Recruiting
CHU
Rouen
Horace ROMAN, MD
About this study
Official 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)
- Conditions
- Endometriosis, Infertility
- Being tested
- complete surgery, In vitro fertilization without surgery
- Keywords
- deep infiltrating endometriosis, endometriosis surgery, In vitro fertilization
- Medical subject headings
- Endometriosis, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete surgeryProcedure or surgery
complete surgery of colorectal deep infiltrating endometriosis
In vitro fertilization without surgeryProcedure or surgery
IVF without endometriosis surgery
| Study group | Role | What they receive |
|---|---|---|
| complete surgery | Experimental | Prior surgery 3 months before IVF followup 1, 6 12 and 24 month after surgery Receives: Procedure: complete surgery; Procedure: In vitro fertilization without surgery |
| In vitro fertilization without surgery | Active comparator | IVF without endometriosis surgery follow up 6, 12 and 24 month after inclusion. Receives: Procedure: In vitro fertilization without surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)
Secondary outcomes (11)
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.
Measured: At the end of the 2nd IVF cycle
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.
Measured: At the end of the 1st IVF cycle (therefore at 6 weeks after each embryo transfer)
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.
Measured: At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)
The IVF complication
rate of hyperstimulation, superinfection, worsening of pain and hospitalization related to IVF procedures in each group.
Measured: 24 months after surgery or inclusion in "IVF without surgery" group
perioperative complications
Complications rate of perioperative surgical excision according to the CLAVIEN-DINDO grading system and to the Comprehensive Complication Index
Measured: 24 months after surgery
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.
Measured: At the end of the 2nd IVF cycle
Endometriosis Health Profile -5 (short form / EHP5)
Evolution of quality life scores in each group
Measured: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Gastrointestinal Quality of Life Index. (GIQLI)
Evolution of quality life scores in each group
Measured: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Short Form (36) Health Survey _ SF 36
Evolution of quality life scores in each group
Measured: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" 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
Measured: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Knowles Eccersley Scott Symptom (KESS) score
Evolution of the bowel function score KESS
Measured: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start17 Nov 2016
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Pierre Collinet, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948972
- Sponsor's protocol ID
- 2015_02
- Other IDs
- 2015 A01536-43
- Acronym
- ENDOFERT
- Status last verified
- Apr 2026
- First submitted
- 4 Oct 2016
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ledu N, Rubod C, Piessen G, Roman H, Collinet P. Management of deep infiltrating endometriosis of the rectum: Is a systematic temporary stoma relevant? J Gynecol Obstet Hum Reprod. 2018 Jan;47(1):1-7. doi: 10.1016/j.jogoh.2017.10.005. Epub 2017 Oct 31.
PubMed 29097291
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility: Complete Surgery + IVF Versus IVF (ENDOFERT)
- ClinicalTrials.gov ID
- NCT02948972
- Acronym / sponsor ID
- ENDOFERT / 2015_02
- Conditions
- Endometriosis, Infertility
- Keywords
- deep infiltrating endometriosis, endometriosis surgery, In vitro fertilization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 17 Nov 2016 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete surgery | Experimental | Procedure: complete surgery, Procedure: In vitro fertilization without surgeryPrior surgery 3 months before IVF followup 1, 6 12 and 24 month after surgery |
| In vitro fertilization without surgery | Active comparator | Procedure: In vitro fertilization without surgeryIVF without endometriosis surgery follow up 6, 12 and 24 month after inclusion. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Contraindication to pregnancy or to IVF
- Viral risk
- Previous IVF cycle(s)
- Previous colorectal surgery
- Need of myomectomy during surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| complete surgerycomplete surgery of colorectal deep infiltrating endometriosis | Procedure or surgery | complete surgery |
| In vitro fertilization without surgeryIVF without endometriosis surgery | Procedure or surgery | In vitro fertilization without surgery, complete surgery |
Primary outcome
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.
11 secondary outcomes
predictive factors
Time frame: At the end of the 2nd IVF cycle
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 rate per embryo transferred
Time frame: At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)
The IVF complication
Time frame: 24 months after surgery or inclusion in "IVF without surgery" group
perioperative complications
Time frame: 24 months after surgery
The cumulative IVF cycle cancellation rate
Time frame: At the end of the 2nd IVF cycle
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
Gastrointestinal Quality of Life Index. (GIQLI)
Time frame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
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
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
Knowles Eccersley Scott Symptom (KESS) score
Time frame: during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 29097291Ledu N, Rubod C, Piessen G, Roman H, Collinet P. Management of deep infiltrating endometriosis of the rectum: Is a systematic temporary stoma relevant? J Gynecol Obstet Hum Reprod. 2018 Jan;47(1):1-7. doi: 10.1016/j.jogoh.2017.10.005. Epub 2017 Oct 31.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre Collinet, MD, PhD principal investigator
University Hospital, Lille
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing complete surgery and In vitro fertilization without surgery in people with Endometriosis and Infertility, run by University Hospital, Lille at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Collinet, MD,PhD (+33 320444676 ext. +33, pierre.collinet@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy after 2 IVF cycles (time frame: At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02948972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.