Ignite Creation Date:
2024-05-06 @ 6:21 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05637073
Status:
RECRUITING
Last Update Posted:
2023-05-16
First Post:
2022-10-22
Brief Title:
Effect of Management of the Endometrioma on Ovarian Reserve
Sponsor:
University of Valencia
Organization:
University of Valencia
Study Overview
Official Title:
Impact of the Type of Treatment of the Endometrioma on Ovarian Reserve
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMTERO
Brief Summary:
Investigators aimed at comparing the impact on ovarian reserve of three usual-care management options of endometrioma laparoscopic cystectomy LC hormonal treatment with daily dienogest HT or mere ultrasound control UC
Ovarian reserve will be measured by the effect on the circulating levels of anti-Mullerian hormone AMH Secondary objectives will be effect on pelvic pain other symptoms sexual function quality of life progression in size of the endometrioma impact on work productivity and activity impairment and satisfaction with treatment
Participants will be followed by up to one year
Ovarian reserve will be measured by the effect on the circulating levels of anti-Mullerian hormone AMH Secondary objectives will be effect on pelvic pain other symptoms sexual function quality of life progression in size of the endometrioma impact on work productivity and activity impairment and satisfaction with treatment
Participants will be followed by up to one year
Detailed Description:
Investigators aimed at comparing the impact on ovarian reserve of three usual-care management options of endometrioma laparoscopic cystectomy LC hormonal treatment with daily dienogest HT or mere ultrasound control UC
Secondary objectives were the comparison of the effect on i pelvic pain including dysmenorrhea non-menstrual pelvic pain deep dyspareunia or dyschezia ii other symptoms including menorrhagia gastrointestinal symptoms different to dyschezia or urinary symptoms iii quality of life as assessed by the EHP-30 questionnaire iv sexual functions as assessed the female sexual function index FSFI v progression in the size of the tumor in the case of the two non-surgical approaches vi impact on work productivity and activity impairment vii satisfaction in the patient
A prospective assessment will be performed on a cohort of women with endometrioma diagnosed by ultrasound from diagnosis for up to one year The assignment to each management option will be performed under usual care conditions so that the selected option will result from the shared clinical decision of the clinician with the patient
The target population will be composed of Caucasian premenopausal women between 18-39 years with the diagnosis of endometrioma one or more with a diameter of up to 7 cm by endovaginal ultrasound Body mass index comprised between 17-30 Kgm2
Participants will be controlled at 3 months 6 months and one year
Secondary objectives were the comparison of the effect on i pelvic pain including dysmenorrhea non-menstrual pelvic pain deep dyspareunia or dyschezia ii other symptoms including menorrhagia gastrointestinal symptoms different to dyschezia or urinary symptoms iii quality of life as assessed by the EHP-30 questionnaire iv sexual functions as assessed the female sexual function index FSFI v progression in the size of the tumor in the case of the two non-surgical approaches vi impact on work productivity and activity impairment vii satisfaction in the patient
A prospective assessment will be performed on a cohort of women with endometrioma diagnosed by ultrasound from diagnosis for up to one year The assignment to each management option will be performed under usual care conditions so that the selected option will result from the shared clinical decision of the clinician with the patient
The target population will be composed of Caucasian premenopausal women between 18-39 years with the diagnosis of endometrioma one or more with a diameter of up to 7 cm by endovaginal ultrasound Body mass index comprised between 17-30 Kgm2
Participants will be controlled at 3 months 6 months and one year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None