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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01628432 |
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Date of registration:
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22/06/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Salpingectomy During Conservative Hysterectomy
SALPINGOVA |
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Scientific title:
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Effect of Total Salpingectomy During Conservative Hysterectomy for Benign Disease on Ovarian Function: Non Inferiority Randomized Controlled Trial |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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350 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01628432 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Lobna OULDAMER, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHRU de TOURS |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age = 18 years and less than 52 years
- indication of a conservative hysterectomy for benign disease
- signed informed consent
- non menopausal women (AMH >0,21 ng/ml)
Exclusion Criteria:
- pregnancy
- desire of future pregnancy
- menopausal status
- patient unable to give informed consent
- any physical or psychiatric condition that could impair with patient's ability to
cooperate with post operative data collection
- previous salpingo and /or oophorectomy (unilateral or bilateral)
- genital cancer disease or atypical endometrial hyperplasia
- hyperandrogenia
- any ovarian mass that needs surgical exploration
- any immunotherapy that could interfere with immunological tests
Age minimum:
18 Years
Age maximum:
52 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Leiomyomata Uteri
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Genital Diseases, Female
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Uterine Prolapse
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Hysterotomy; Affecting Fetus
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Adenomyosis, Endometriosis
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Cervical Dysplasia
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Dysfunctional Uterine Bleeding
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Intervention(s)
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Procedure: conservative hysterectomy I
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Procedure: Conservative hysterectomy II
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Primary Outcome(s)
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percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months)
[Time Frame: one year]
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Secondary Outcome(s)
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AMH measurement at 3 days, 6 weeks, and 6, 12 months after hysterectomy endovaginal ultrasound evaluation of the ovarian volume and vascularisation quality of life (WHQ questionnaire) reintervention procedures complications
[Time Frame: day3, week 6, month 6 and month 12]
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Secondary ID(s)
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PHRN11/LO/SALPINGOVA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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