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

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

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.

Sponsors & Collaborators

• Haaglanden Medical Centre

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Reinier de Graaf Groep

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Leiden University Medical Center

  lead OTHER

Principal Investigators

• Mathijs D. Blikkendaal, MD, PhD · Nederlandse Endometriose Kliniek (NEK), Reinier de Graaf Gasthuis

• Andries RH Twijnstra, MD, PhD · Leiden University Medical Center

• Astrid EP Cantineau, MD, PhD · University Medical Center Groningen

• Jacques Maas, MD, PhD · Maastricht University Medical Center

• Annemiek Nap, MD, PhD · Radboud University Medical Center

• Dana Huppelschoten · Catharina Ziekenhuis

• Simone Broer · UMC Utrecht

• Tobias Limperg · Nederlandse Endometriose Kliniek (NEK), Reinier de Graaf Gasthuis

• Yvonne Louwers · Erasmus Medical Center

• Marieke Verberg · Medisch Spectrum Twente

Eligibility

Min Age

21 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-17

Primary Completion

2028-07-31

Completion

2029-01-01

Countries

• Netherlands

Study Locations