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

NCT05677269 RECRUITING

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.

Details

Lead sponsor	Leiden University Medical Center
Status	RECRUITING
Enrolment	339
Start date	2023-02-17
Completion	2029-01-01

Conditions

• Endometriosis, Rectum
• Endometriosis of Colon
• Subfertility, Female

Interventions

• Laparoscopic excision of endometriosis, including colorectal endometriosis
• In vitro fertilisation or intracytoplasmic sperm injection

Primary outcomes

• Cumulative live birth rate — 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) )
  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

Countries

Netherlands