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Not Yet Recruiting NCT05677269

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

Conditions: Endometriosis, Rectum, Endometriosis of Colon, Subfertility, Female

Sex: Female
Ages: 18 Years – 42 Years
Enrollment: 200
Sponsor: Haaglanden Medical Centre

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 in vitro fertilization (IVF), and better patient reported outcome measures (PROMs) compared to an IVF treatment trajectory.

Eligibility Criteria

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, small bowel) detected with ultrasound, MRI or diagnostic laparoscopy.The patient an active wish to conceive and experience at least one of the following criteria:At least one year of non-conceptionInability to have timed intercourse because of pain (dyspareunia and/or chronic pelvic pain)Severe complaints (expectant management is not acceptable (anymore)The patient is at the beginning of her fertility treatment and faces the choice between IVF or laparoscopic colorectal endometriosis excision surgery or is on the waiting list for a respective treatmentPatients undergoing intracytoplasmic sperm injection (ICSI), not due to male factor infertility, but for example in case of multiple cancelled embryo transfers due to no fertilization.Exclusion Criteria:Deep endometriosis without bowel involvementUnilateral of bilateral hydronephrosisSevere bowel stenosis with high risk of problems during pregnancyContra-indication for IVF (e.g. partner with severe male infertility (<1x10^16 motility count in semen analysis, untreated uterine factor infertility, maltreated/untreated systemic or malignant disease or severe risk factors for oocyte aspiration, anti-Mullerian hormone or antral follicle count <p10 (adjusted for age))Not able to read, write and understand Dutch

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05677269). StuddyBuddy aggregates publicly available trial information.