RecruitingNCT05677269

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


Sponsor

Leiden University Medical Center

Enrollment

339 participants

Start Date

Feb 17, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 21 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called In vitro fertilisation or intracytoplasmic sperm injection and a procedure called Laparoscopic excision of endometriosis, including colorectal endometriosis for people with endometriosis of colon, endometriosis, rectum, and other related conditions. The study is currently recruiting participants at 10 locations. People eligible for this study include women aged 21 Years to 40 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELaparoscopic 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.

PROCEDUREIn 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.


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

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NCT05677269


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