The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory

NCT05677269 | Recruiting DMC

• 1 other identifier: N22.085
• Study Type: observational
• Target: 339
• Locations: 1 country
• Sites: 10

Brief Summary

To goal of this study is to determine whether laparoscopic resection of colorectal endometriosis results in an increased cumulative live birth rate (CLBR) both spontaneous and after ART (including in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), and better patient reported outcome measures (PROMs) compared to an IVF/ICSI treatment trajectory.

Conditions

Endometriosis, Rectum; Endometriosis of Colon; Subfertility, Female

Keywords

Colorectal endometriosis; Subfertility; Surgery; In vitro fertilisation; Live birth rate; Quality of life; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Cumulative live birth rate

  Live birth is defined as the complete expulsion or extraction from a women of a product of fertilization, after 20 weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut of the placenta is attached. A birth weight of 350 grams or more can be used if gestational age is unknown

  At the end of the study period (live birth or after 3 IVF/ICSI attempts and/or surgery in the follow-up period (40 months) )

Secondary Outcomes (7)

• Endometriosis specific symptoms

  At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery.

• Quality of life in general

  At baseline (T=0: when informed consent is granted), 6, 12, 18, 24, 30, 36 and 40 months and in case of surgery, before surgery.

• Bowel specific symptoms

  At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery.

• Pain scores

  At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery.

• Productivity costs

  At baseline (T=6, 12, 18, 24, 30, 36 and 40 months and in case of surgery, before surgery.

Study Arms (1)

Colorectal endometriosis patients

Subfertile women between 21 and 40 years with colorectal endometriosis facing the choice between IVF/ICSI or laparoscopic resection of (colorectal) endometriosis.

Procedure: Laparoscopic excision of endometriosis, including colorectal endometriosis; Procedure: In vitro fertilisation or intracytoplasmic sperm injection

Interventions

Laparoscopic excision of endometriosis, including colorectal endometriosis PROCEDURE

Laparoscopic resection of deep endometriosis, including colorectal endometriosis, in a (candidate) level 2 centre of expertise. Complete resection can exist of either 'shaving' of the nodule from the bowel (leaving the lumen closed), discoid excision or segmental resection, depending on the nodule size and extent of disease.

Colorectal endometriosis patients

In vitro fertilisation or intracytoplasmic sperm injection PROCEDURE

IVF/ICSI treatment trajectory (maximum of 3 cycles), according to the local protocol. Preferably preceded by 3 months downregulation with either Gonadotrophin-releasing hormone (GnRH) analogue or oral contraceptive pill. One IVF/ICSI cycle is defined as the transfer of all the embryos created after one follicle puncture until pregnancy confirmation or failure of the last embryo transfer.

Colorectal endometriosis patients

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: Endometriosis only affects women
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subfertile women between 21 and 40 years with colorectal endometriosis facing the choice (at the start of their treatment trajectory or after one or two unsuccessful IVF/ICSI cycles) between IVF/ICSI or laparoscopic excision of (colorectal) endometriosis to increase the chance to conceive (naturally)

You may qualify if:

• Colorectal endometriosis defined as endometriosis involving the (colo)rectum:
• #Enzian classification score C1,C2,C3 (C=rectum) or FI (F=far locations, I=sigmoid colon) detected with ultrasound or MRI;
• Women in a heterosexual or in a same-sex relationship;
• The patient has an active wish to conceive and experiences at least one of the following criteria:
• At least one year of non-conception (either spontaneous of after intra uterine inseminations)
• Inability to have timed intercourse because of pain (dyspareunia and/or chronic pelvic pain)
• Severe complaints (expectant management is not acceptable (anymore)
• The patients has an indication for IVF/ICSI according to Dutch guidelines (Werkgroep netwerkrichtlijn, december 2010);
• failed intra uterine insemination
• male factor subfertility (oligoasthenoteratozoospermia defined as VCM \<1 million)
• bilateral tubal pathology (e.g. bilateral hydrosalpinx, bilateral tubal occlusion)
• age \> 38 years and (unexplained) subfertility
• severe endometriosis in case of subfertility
• The patient is faces the choice between IVF/ICSI or laparoscopic (colorectal) endometriosis or is on the waiting list for a respective treatment at T=0 (at the beginning of the treatment trajectory), T=1 (after one unsuccessful IVF/ICSI cycle) or T=2 (after 2 unsuccessful IVF/ICSI cycles)

You may not qualify if:

• Patients with deep endometriosis without colorectal involvement;
• Patients who conceive spontaneously prior to intervention;
• Patients requiring surgery on short notice and therefore unable to opt for IVF/ICSI (e.g. in case of unilateral or bilateral hydronephrosis, severe bowel stenosis and suspicion of an impending ileus);
• Patients with a contra-indication for IVF/ICSI (e.g. diminished ovarian reserve (premature ovarian failure) (AMH (when available) \<p10 adjusted for age), untreated congenital uterine abnormalities, maltreated/untreated systemic or malignant disease or severe risk factors for oocyte aspiration);
• Patients diagnosed with other diseases causing infertility (e.g. recurrent miscarriages, antiphospholipid syndrome);
• Not able to read and understand Dutch or English.

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Haaglanden Medical Centre: collaborator
• University Medical Center Groningen: collaborator
• Maastricht University Medical Center: collaborator
• Radboud University Medical Center: collaborator
• Reinier de Graaf Groep: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• UMC Utrecht: collaborator

Study Sites (10)

Catharina Ziekenhuis

Eindhoven, Netherlands

RECRUITING

Medical Spectrum Twente

Enschede, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

Leiden University Medical Center

Leiden, Netherlands

RECRUITING

Maastricht University Medical Center

Maastricht, Netherlands

RECRUITING

Radboud university medical center

Nijmegen, Netherlands

RECRUITING

Erasmus Medical Centre

Rotterdam, Netherlands

RECRUITING

Haaglanden Medical Center

The Hague, Netherlands

RECRUITING

Utrecht Medical Center

Utrecht, Netherlands

RECRUITING

Nederlandse Endometriose Kliniek (Reinier de Graaf Gasthuis)

Voorburg, Netherlands

RECRUITING

Related Publications (1)

• F Barra, C Scala, S Bogliolo, N Di Donato, M Ceccaroni, S Ferrero, O-309 Surgery versus IVF/ICSI in infertile women with rectosigmoid endometriosis: the FERTILITY-RECTOSIGMOID study, Human Reproduction, Volume 37, Issue Supplement_1, July 2022

  RESULT

MeSH Terms

Conditions

Endometriosis; Infertility, Female; Infertility

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in Vitro; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Mathijs D. Blikkendaal, MD, PhD

  Nederlandse Endometriose Kliniek (NEK), Reinier de Graaf Gasthuis

  PRINCIPAL INVESTIGATOR

• Andries RH Twijnstra, MD, PhD

  Leiden University Medical Center

  STUDY CHAIR

• Astrid EP Cantineau, MD, PhD

  University Medical Center Groningen

  STUDY CHAIR

• Jacques Maas, MD, PhD

  Maastricht University Medical Center

  STUDY CHAIR

• Annemiek Nap, MD, PhD

  Radboud University Medical Center

  STUDY CHAIR

• Dana Huppelschoten

  Catharina Ziekenhuis

  STUDY CHAIR

• Simone Broer

  UMC Utrecht

  STUDY CHAIR

• Tobias Limperg

  Nederlandse Endometriose Kliniek (NEK), Reinier de Graaf Gasthuis

  STUDY CHAIR

• Yvonne Louwers

  Erasmus Medical Center

  STUDY CHAIR

• Marieke Verberg

  Medisch Spectrum Twente

  STUDY CHAIR

Central Study Contacts

Mathijs D. Blikkendaal, MD,PhD

CONTACT

088 979 44 89; M.Blikkendaal@rdgg.nl

Rozemarijn de Koning, MD

CONTACT

r.de_koning@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 40 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: January 10, 2023
• Study Start: February 17, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (10)