Q3146315 (Q3146315): Difference between revisions
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(Created claim: summary (P836): 40 % of patients with endometriomas have sterility. However, the treatment of choice is laparoscopic cystectomy that is associated with a decrease in ovarian reserve. Main objective: Compare ovarian reserve after puncture and sclerosis with alcohol of endometriomas versus conventional surgery (antimüllerian hormone (AMH), FSH and anthral follicle count (RFA)). Secondary objectives: Compare the variation in tumor markers (HE4 and Ca125), complic...) |
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40 % of patients with endometriomas have sterility. However, the treatment of choice is laparoscopic cystectomy that is associated with a decrease in ovarian reserve. Main objective: Compare ovarian reserve after puncture and sclerosis with alcohol of endometriomas versus conventional surgery (antimüllerian hormone (AMH), FSH and anthral follicle count (RFA)). Secondary objectives: Compare the variation in tumor markers (HE4 and Ca125), complications, recurrences and costs between the two procedures. Methodology: Phase I (pilot study) Prospective observation of cohorts, multicenter, includes 40 patients. Phase II (Clinical trial) randomised, parallel groups, not masked. Inclusion criteria: Female sex, age =18 and =40 years, ultrasound suspicion of 35 to 100 mm diameter unilocular endometrioma when symptomatic, and 50 to 100 mm in asymptomatics, Ca125 <200 IU/mL, HE4 <70pM, and AMH between 1.2 and 4ng/mL. Exclusion criteria: Age <18 or > 40 years, previous oophorectomy, size <35 or >100 mm, suspected high risk of malignancy or extraovarian endometriosis, hormonal treatment during the previous 3 months, pregnant and patients who do not wish to participate in the study or with mental disability. Randomisation in 2 groups: (a) Study Group: Puncture and sclerosis with alcohol; (B) Control group: Laparoscopic cystectomy. The main variables (AMH and RFA) will be quantified before treatment, at month, 3 and 6 months. The complications, recurrences and costs of each treatment shall be collected. (English) | |||||||||||||||
| Property / summary: 40 % of patients with endometriomas have sterility. However, the treatment of choice is laparoscopic cystectomy that is associated with a decrease in ovarian reserve. Main objective: Compare ovarian reserve after puncture and sclerosis with alcohol of endometriomas versus conventional surgery (antimüllerian hormone (AMH), FSH and anthral follicle count (RFA)). Secondary objectives: Compare the variation in tumor markers (HE4 and Ca125), complications, recurrences and costs between the two procedures. Methodology: Phase I (pilot study) Prospective observation of cohorts, multicenter, includes 40 patients. Phase II (Clinical trial) randomised, parallel groups, not masked. Inclusion criteria: Female sex, age =18 and =40 years, ultrasound suspicion of 35 to 100 mm diameter unilocular endometrioma when symptomatic, and 50 to 100 mm in asymptomatics, Ca125 <200 IU/mL, HE4 <70pM, and AMH between 1.2 and 4ng/mL. Exclusion criteria: Age <18 or > 40 years, previous oophorectomy, size <35 or >100 mm, suspected high risk of malignancy or extraovarian endometriosis, hormonal treatment during the previous 3 months, pregnant and patients who do not wish to participate in the study or with mental disability. Randomisation in 2 groups: (a) Study Group: Puncture and sclerosis with alcohol; (B) Control group: Laparoscopic cystectomy. The main variables (AMH and RFA) will be quantified before treatment, at month, 3 and 6 months. The complications, recurrences and costs of each treatment shall be collected. (English) / rank | |||||||||||||||
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| Property / summary: 40 % of patients with endometriomas have sterility. However, the treatment of choice is laparoscopic cystectomy that is associated with a decrease in ovarian reserve. Main objective: Compare ovarian reserve after puncture and sclerosis with alcohol of endometriomas versus conventional surgery (antimüllerian hormone (AMH), FSH and anthral follicle count (RFA)). Secondary objectives: Compare the variation in tumor markers (HE4 and Ca125), complications, recurrences and costs between the two procedures. Methodology: Phase I (pilot study) Prospective observation of cohorts, multicenter, includes 40 patients. Phase II (Clinical trial) randomised, parallel groups, not masked. Inclusion criteria: Female sex, age =18 and =40 years, ultrasound suspicion of 35 to 100 mm diameter unilocular endometrioma when symptomatic, and 50 to 100 mm in asymptomatics, Ca125 <200 IU/mL, HE4 <70pM, and AMH between 1.2 and 4ng/mL. Exclusion criteria: Age <18 or > 40 years, previous oophorectomy, size <35 or >100 mm, suspected high risk of malignancy or extraovarian endometriosis, hormonal treatment during the previous 3 months, pregnant and patients who do not wish to participate in the study or with mental disability. Randomisation in 2 groups: (a) Study Group: Puncture and sclerosis with alcohol; (B) Control group: Laparoscopic cystectomy. The main variables (AMH and RFA) will be quantified before treatment, at month, 3 and 6 months. The complications, recurrences and costs of each treatment shall be collected. (English) / qualifier | |||||||||||||||
point in time: 12 October 2021
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Revision as of 14:42, 12 October 2021
Project Q3146315 in Spain
| Language | Label | Description | Also known as |
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| English | No label defined |
Project Q3146315 in Spain |
Statements
33,250.0 Euro
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66,500.0 Euro
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50.0 percent
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1 January 2017
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31 March 2020
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INSTITUTO DE INVESTIGACION BIOMEDICA DE BELLVITGE
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41°21'35.50"N, 2°5'59.24"E
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08101
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El 40% de las pacientes con endometriomas presentan esterilidad. Sin embargo, el tratamiento de elección es la quistectomía laparoscópica que se asocia con una disminución de la reserva ovárica. Objetivo principal: Comparar la reserva ovárica tras la punción y esclerosis con alcohol de los endometriomas frente a la cirugía convencional (hormona antimülleriana (AMH), FSH y recuento folículos antrales (RFA)). Objetivos secundarios: Comparar la variación de los marcadores tumorales (HE4 y Ca125), de complicaciones, recidivas y de costes entre ambos procedimientos. Metodología: Fase I (estudio piloto) Observacional prospectivo de cohortes, multicéntrico, incluye 40 pacientes. Fase II (Ensayo clínico) randomizado, grupos paralelos, no enmascarado. Criterios de inclusión: Sexo femenino, edad =18 y =40 años, sospecha ecográfica de endometrioma unilocular de 35 a 100 mm de diámetro cuando son sintomáticos, y de 50 a 100 mm en asintomaticos, Ca125 <200 UI/mL, HE4 <70pM, y AMH entre 1.2 y 4ng/mL. Criterios de exclusión: Edad <18 o > 40 años, ooforectomia previa, tamaño <35 ó >100 mm, sospecha de alto riesgo de malignidad o endometriosis extraovárica, tratamiento hormonal durante los 3 meses previos, embarazadas y pacientes que no deseen participar en el estudio o con incapacidad mental. Randomización en 2 grupos: (a) Grupo estudio: Punción y esclerosis con alcohol; (b) Grupo control: Quistectomía laparoscópica. Las variables principales (AMH y RFA) se cuantificarán antes del tratamiento, al mes, 3 y 6 meses. Se recogerán las complicaciones, recidivas y los costes derivados de de cada uno de los tratamientos. (Spanish)
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40 % of patients with endometriomas have sterility. However, the treatment of choice is laparoscopic cystectomy that is associated with a decrease in ovarian reserve. Main objective: Compare ovarian reserve after puncture and sclerosis with alcohol of endometriomas versus conventional surgery (antimüllerian hormone (AMH), FSH and anthral follicle count (RFA)). Secondary objectives: Compare the variation in tumor markers (HE4 and Ca125), complications, recurrences and costs between the two procedures. Methodology: Phase I (pilot study) Prospective observation of cohorts, multicenter, includes 40 patients. Phase II (Clinical trial) randomised, parallel groups, not masked. Inclusion criteria: Female sex, age =18 and =40 years, ultrasound suspicion of 35 to 100 mm diameter unilocular endometrioma when symptomatic, and 50 to 100 mm in asymptomatics, Ca125 <200 IU/mL, HE4 <70pM, and AMH between 1.2 and 4ng/mL. Exclusion criteria: Age <18 or > 40 years, previous oophorectomy, size <35 or >100 mm, suspected high risk of malignancy or extraovarian endometriosis, hormonal treatment during the previous 3 months, pregnant and patients who do not wish to participate in the study or with mental disability. Randomisation in 2 groups: (a) Study Group: Puncture and sclerosis with alcohol; (B) Control group: Laparoscopic cystectomy. The main variables (AMH and RFA) will be quantified before treatment, at month, 3 and 6 months. The complications, recurrences and costs of each treatment shall be collected. (English)
12 October 2021
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Hospitalet de Llobregat, L'
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Identifiers
PI16_00801
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