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RECRUITING

NCT05677269

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

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

21 Years - 40 Years

Study Type

OBSERVATIONAL

Enrollment

339

Start Date

2023-02-17

Completion Date

2029-01-01

Last Updated

2024-11-21

Healthy Volunteers

Not specified

Conditions

Endometriosis, Rectum Endometriosis of Colon Subfertility, Female

Interventions

PROCEDURE

Laparoscopic excision of endometriosis, including colorectal endometriosis

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.

PROCEDURE

In vitro fertilisation or intracytoplasmic sperm injection

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.

Inclusion Criteria: * 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) Exclusion Criteria: * 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.

Locations (10)

Catharina Ziekenhuis

Eindhoven, Netherlands

Medical Spectrum Twente

Enschede, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Leiden University Medical Center

Leiden, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Radboud university medical center

Nijmegen, Netherlands

Erasmus Medical Centre

Rotterdam, Netherlands

Haaglanden Medical Center

The Hague, Netherlands

Utrecht Medical Center

Utrecht, Netherlands

Nederlandse Endometriose Kliniek (Reinier de Graaf Gasthuis)

Voorburg, Netherlands