NCT05677269|RecruitingDMC
The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory
TOSCA
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TOSCA
Sponsor study identifier
observational
339
1 country
10
Study Start
February 17, 2023
Actual (reported)Primary Completion
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 9, 2022
Actual (reported)January 10, 2023
Actual (reported)February 17, 2023
Actual (reported)July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Cumulative live birth rate
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
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) )
Endometriosis specific symptoms
At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery.
Subfertile women between 21 and 40 years with colorectal endometriosis facing the choice between IVF/ICSI or laparoscopic resection of (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.
Subfertile women between 21 and 40 years with colorectal endometriosis facing the choice (at the start of their treatment trajectory or after one or two unsuccessful IVF/ICSI cycles) between IVF/ICSI or laparoscopic excision of (colorectal) endometriosis to increase the chance to conceive (naturally)
Catharina Ziekenhuis
Eindhoven, Netherlands
Medical Spectrum Twente
Enschede, Netherlands
University Medical Center Groningen
Groningen, Netherlands
F Barra, C Scala, S Bogliolo, N Di Donato, M Ceccaroni, S Ferrero, O-309 Surgery versus IVF/ICSI in infertile women with rectosigmoid endometriosis: the FERTILITY-RECTOSIGMOID study, Human Reproduction, Volume 37, Issue Supplement_1, July 2022
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
First Submitted
December 9, 2022
First Posted
January 10, 2023
Study Start
February 17, 2023
Actual (reported)Primary Completion
July 2028
EstimatedSurgery for Lower Rectum Deep Endometriosis (Segmental/Disc) - Prospective Comparison of Digestive Symptoms and Pain
Quality of life in general
At baseline (T=0: when informed consent is granted), 6, 12, 18, 24, 30, 36 and 40 months and in case of surgery, before surgery.
Bowel specific symptoms
At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery.
Pain scores
At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery.
Productivity costs
At baseline (T=6, 12, 18, 24, 30, 36 and 40 months and in case of surgery, before surgery.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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
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
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 21, 2024
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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