Impact of Salpingectomy on Ovarian Reserve (SALPOVA)
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Study type
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Identifiers
Details and patient eligibility
About
Epithelial cancer of the ovaries is the most severe form of gynecologic cancer; a significant proportion of ovarian cancers originate from the Fallopian tube. Guidelines therefore now recommend systematically associating prophylactic salpingectomy to benign hysterectomy. The principal objective of the present study is to assess the impact of salpingectomy on ovarian reserve by anti-Müllerian hormone (AMH) assay and calculating the Doppler index of vascular resistance in the ovarian vessels. The secondary objective is to compare ovarian reserve results between two coagulation techniques used in salpingectomy: bipolar electric energy versus ultrasound.
The study design is single-center, prospective, before-and-after, with open randomization between two groups defined by coagulation technique.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Female subjects aged 18
- Scheduled surgery: bilateral laparoscopic salpingectomy associated to hysterectomy for benign indication
Exclusion criteria
- Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
- Pregnancy, ongoing or planned during the study period
- History of bilateral salpingectomy
- Salpingectomy associated with pelvic cancer
- Oral hormonal contraception during the study period
- Menopause
- Inability to understand information provided
- Not covered by a national health insurance scheme, prisoner or under administrative supervision.
Trial design
Primary purpose
Allocation
Interventional model
Masking
96 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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