EFFORT: Impact of Operation on Fertility for Women With Severe Endometriosis

• Sponsor: Horsens Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04610710
• Collaborator: Aarhus University Hospital (Other), Clinique Tivoli Ducos (Other)
• Enrollment: 352
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site: 117.3
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

The EFFORT study compares the impact on fertility of operation or fertility treatment (IVF, in vitro fertilization) in a multicenter randomized controlled trial. The study population consists of women with colorectal deep infiltrating endometriosis and a pregnancy intention. These women will be randomized to either of the two treatment groups: Group A = Operation or Group B = fertility treatment (IVF). Group A will be further divided postoperatively into spontaneous conception or IVF depending on the Endometriosis Fertility Index score.

Condition or Disease	Intervention/Treatment	Phase
Deep Endometriosis; Infertility, Female	Procedure: Operation; Procedure: Fertility treatment	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 352 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Clinical Trail (RCT)Randomized Clinical Trail (RCT)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparing Impact of Operation and Fertility Treatment on Fertility for Women With Deep Infiltrating Endometriosis: A Multicenter Randomized Controlled Trial
• Actual Study Start Date: Aug 1, 2020
• Anticipated Primary Completion Date: Jan 31, 2024
• Anticipated Study Completion Date: Jul 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Operation Operation for severe endometriosis	Procedure: Operation; Operation for deep infiltrating endometriosis
Active Comparator: Fertility treatment Fertility treatment for women with severe endometriosis.	Procedure: Fertility treatment; In vitro fertilisation (IVF) and IVF-intracytoplasmic injection (ICSI)

Outcome Measures

Primary Outcome Measures

1. Cumulative pregnancy rate (CPR) [18 months]

   Rate of cumulative pregnancies defined as a fetal heartbeat by ultrasound at gestational week 6 to 8

2. Live birth rate (LBR) [18 months]

   Rate of live births

Secondary Outcome Measures

1. Non-viable pregnancies [18 months]

   Number of biochemical pregnancies, miscarriages, missed abortions, extrauterine pregnancies and pregnancies of unknown location (PUL)

2. Ovarian potential [Baseline and 9-18 months]

   Concentration of Anti-Müllerian hormone (AMH)

3. Time to pregnancy [18 months]

   Shortest time from intervention date to date of visualisation of the first ongoing pregnancy

4. Postoperative complications [18 months]

   Rate of complications in accordance to Clavien-Dindo Classification, including anastomotic leakage or stenosis, ureteral lesion or obstruction, pelvic abscess, fistula, bladder or bowel perforation and urinary retention

5. Fertility treatment complications [18 months]

   Rate of hospital admissions, bleeding, superinfection, worsening of pain or having ovarian hyperstimulation syndrome (OHSS)

6. Pain score [Baseline, 9 and 18 months]

   Numeric Rating Scale (NRS) score from 0 to 10, where 10 implies the worst pain

7. Quality of Life (QoL) [Baseline, 9 and 18 months]

   Development in Endometriosis Health Profile (EHP-30+23), including section C (sexual function QoL questions) and section F (fertility QoL questions)

8. Delayed bowel function [Baseline, 9 and 18 months]

   Development in bowel function rated by Low Anterior Resection Syndrome (LARS) score

9. Delayed bladder function [Baseline, 9 and 18 months]

   Development in urinary tract function rated by International Consultation on Incontinence Questionnaire (ICIQ- FLUTS)

10. Endometriosis hormonal and inflammatory status [Baseline and 9-18 months]

    Concentrations of hormonal and inflammatory markers in blood samples

11. Follicles, oocytes, fertilized oocytes, blastocysts, and frozen embryos [18 months]

    Number of follicles as measured at last scan prior to oocyte pick-up (OPU), number of oocytes at OPU, fertilized oocytes, blastocysts and frozen embryos

12. Blastocyst morphology score [18 months]

    Gardner scoring system, Steer grading system, Veecks criteria, or other scoring systems of blastocyst morphology

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 38 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Rectosigmoid endometriosis and wish for surgery

• Pregnancy intention for at least 6 months

• AMH above 5 pmol/ml

• Maximum of 2 previous IVF treatments

• Male partner

Exclusion Criteria:

• Endometriosis involving the ureter unilaterally or bilaterally (randomization unethical)

• BMI above 32

• Contraindication for IVF (untreated uterine factor infertility, untreated/maltreated systemic or malignant disease, oocyte aspiration severely riskful (e.g. severe abdominal adhesions)

• No wish for randomization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus N	Central Region	Denmark	8200
2	Horsens Regional Hospital	Horsens	Central Region	Denmark	8700
3	The Endometriosis Center, Clinique Tivoli-Ducos	Bordeaux		France

Sponsors and Collaborators

• Horsens Hospital
• Aarhus University Hospital
• Clinique Tivoli Ducos

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maja Raos, MD, Horsens Hospital
• ClinicalTrials.gov Identifier: NCT04610710
• Other Study ID Numbers: Horsens MR
• First Posted: Oct 30, 2020
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility; Endometriosis; Infertility, Female

Study Results

No Results Posted as of Feb 9, 2022