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| Name | Class |
|---|---|
| Haaglanden Medical Centre | OTHER |
| University Medical Center Groningen | OTHER |
| Maastricht University Medical Center | OTHER |
| Radboud University Medical Center |
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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.
Endometriosis is characterized by extra-uterine endometrium like tissue and affects 10-15% of the women in their reproductive years and in 5-12% of these women colorectal endometriosis is present. The quality of life is lowered due to severe pain symptoms (dysmenorrhea, dyschezia, dysuria, chronic pelvic pain) and subfertility.The management of colorectal endometriosis-related subfertility is challenging. While the impact of colorectal endometriosis per se remains inconclusive as other intraperitoneal endometriosis lesions are frequently present, fertility is most likely affected by multiple mechanisms including inflammatory alterations in peritoneal fluid, alterations in estrogen and progesterone hormone levels, lowered endometrium receptivity, associated adenomyosis, a lower ovarian reserve (in case endometriomas are present) and adhesion formation that disrupts adnexal anatomy and function. Usually, surgery is preferred in case of dominant pain complaints, while IVF/ICSI is started when the wish to conceive is dominant. Recent evidence suggests a CLBR of 44.9% in patients with rectosigmoid endometriosis treated by surgery compared to 55.9% after 4 cycles of IVF/ICSI treatment without surgery. In the Netherlands, the number of reimbursed IV/ICSI attempts in limited to three. In addition, a combined strategy may result in even higher cumulative live birth rates. However, the place and optimal timing of surgery in patients with colorectal endometriosis and a desire to have children is unknown.
To provide robust evidence that can be extrapolated to the Dutch healthcare system, this study aims to determine whether surgical excision of colorectal endometriosis results in increased CLBR both spontaneous and after IVF/ICSI, and better PROMs compared to an IVF/ICSI treatment trajectory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colorectal endometriosis patients | Subfertile women between 21 and 40 years with colorectal endometriosis facing the choice between IVF/ICSI or laparoscopic resection of (colorectal) endometriosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic excision of endometriosis, including colorectal endometriosis | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) ) |
| Measure | Description | Time Frame |
|---|---|---|
| Endometriosis specific symptoms | Endometriosis Health Profile-30 (EHP-30). The overall EHP-30 score ranges from 0 to 100, with a high score indicating poorer health-related quality of life. | At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery. |
| Quality of life in general |
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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) detected with ultrasound or MRI;
Women in a heterosexual or in a same-sex relationship;
The patient has an active wish to conceive and experiences at least one of the following criteria:
The patients has an indication for IVF/ICSI according to Dutch guidelines (Werkgroep netwerkrichtlijn, december 2010);
The patient is faces the choice between IVF/ICSI or laparoscopic (colorectal) endometriosis or is on the waiting list for a respective treatment at T=0 (at the beginning of the treatment trajectory), T=1 (after one unsuccessful IVF/ICSI cycle) or T=2 (after 2 unsuccessful IVF/ICSI cycles)
Exclusion Criteria:
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Endometriosis only affects women
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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathijs D. Blikkendaal, MD,PhD | Contact | 088 979 44 89 | M.Blikkendaal@rdgg.nl | |
| Rozemarijn de Koning, MD | Contact | r.de_koning@lumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Mathijs D. Blikkendaal, MD, PhD | Nederlandse Endometriose Kliniek (NEK), Reinier de Graaf Gasthuis | Principal Investigator |
| Andries RH Twijnstra, MD, PhD | Leiden University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catharina Ziekenhuis | Recruiting | Eindhoven | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
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| OTHER |
| Reinier de Graaf Groep | OTHER |
| Catharina Ziekenhuis Eindhoven | OTHER |
| UMC Utrecht | OTHER |
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|
| In vitro fertilisation or intracytoplasmic sperm injection | Procedure | 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. |
|
EuroQql five-dimensional 5 levels (EQ-5D-5L) and EuroQql Visual Analog Scale (EQ-VAS). According to the Dutch scoring algorithm, the EQ-5D-5L score index value ranges from -0.446 (55555 worst health state) to 1 (11111, best health state). Overall health will be represented by the EQ-VAS, ranging from 0 to 100, with higher scores indicating better health. |
| 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 | Lower Anterior Resection Syndrome score (LARS score). The total LARS score ranges from 0, indicating no LARS to 42 points, indicating major LARS. | At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery. |
| Pain scores | NRS score for dysmenorrhea, dysuria, dyschezia, dyspareunia and chronic pelvic pain. The NRS scale ranges from 0 (no pain) to 10 (worst pain imaginable). | At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery. |
| Productivity costs | Productivity costs questionnaire: institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ). Productivity costs will be measured by calculating absence from paid work (absenteeism), reduced productivity at paid work (presenteeism), and productivity loss in unpaid work. Hours of productivity loss will be translated by a standard cost price of productivity per hour. | At baseline (T=6, 12, 18, 24, 30, 36 and 40 months and in case of surgery, before surgery. |
| Medical costs per group | Costs surgery, costs IVF/ICSI treatment, costs extra hospital admissions / emergency room visits / visits outpatient care | 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) ) |
| Complications | Intraoperative and postoperative complications, IVF/ICSI associated complications, pregnancy complications | 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) ) |
| Astrid EP Cantineau, MD, PhD | University Medical Center Groningen | Study Chair |
| Jacques Maas, MD, PhD | Maastricht University Medical Center | Study Chair |
| Annemiek Nap, MD, PhD | Radboud University Medical Center | Study Chair |
| Dana Huppelschoten | Catharina Ziekenhuis | Study Chair |
| Simone Broer | UMC Utrecht | Study Chair |
| Tobias Limperg | Nederlandse Endometriose Kliniek (NEK), Reinier de Graaf Gasthuis | Study Chair |
| Yvonne Louwers | Erasmus Medical Center | Study Chair |
| Marieke Verberg | Medisch Spectrum Twente | Study Chair |
| Medical Spectrum Twente | Recruiting | Enschede | Netherlands |
|
| University Medical Center Groningen | Recruiting | Groningen | Netherlands |
|
| Leiden University Medical Center | Recruiting | Leiden | Netherlands |
|
| Maastricht University Medical Center | Recruiting | Maastricht | Netherlands |
|
| Radboud university medical center | Recruiting | Nijmegen | Netherlands |
|
| Erasmus Medical Centre | Recruiting | Rotterdam | Netherlands |
|
| Haaglanden Medical Center | Recruiting | The Hague | Netherlands |
|
| Utrecht Medical Center | Recruiting | Utrecht | Netherlands |
|
| Nederlandse Endometriose Kliniek (Reinier de Graaf Gasthuis) | Recruiting | Voorburg | Netherlands |
|
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D007247 | Infertility, Female |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D020554 | Sperm Injections, Intracytoplasmic |
| ID | Term |
|---|---|
| D005307 | Fertilization in Vitro |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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