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Effect of Total Salpingectomy During Conservative Hysterectomy for Benign Disease on Ovarian Function: Non Inferiority Randomized Controlled Trial

18 Years
52 Years
Open (Enrolling)
Genital Diseases, Female, Hysterotomy; Affecting Fetus, Leiomyomata Uteri, Adenomyosis, Endometriosis, Dysfunctional Uterine Bleeding, Cervical Dysplasia, Uterine Prolapse

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Trial Information

Effect of Total Salpingectomy During Conservative Hysterectomy for Benign Disease on Ovarian Function: Non Inferiority Randomized Controlled Trial

Hysterectomy is one of the most common gynecologic procedures performed in clinical
practice. In this study we focused on non menopausal patients under 52 years having
hysterectomies for benign disease : uterine leiomyomas, adenomyosis, endometriosis,
dysfunctional uterine bleeding, genital prolapse, cervical dysplasia... with failure of
conservative treatment.

the standard procedure during hysterectomy with conservation of the ovaries has been the
preservation of fallopian tubes with the clamps placed as close to the uterine corpus as
possible. this is suggested to decrease interference with the vascular structures in the
mesosalpinx and mesovarium. however it is unclear whether tubal conservation at the time of
hysterectomy has any influence on ovarian blood flow or ovarian reserve. another point to be
considered is the occurrence of post-hysterectomy carcinoma in the preserved fallopian tube,
theoretically, these cases could be prevented if tubal excision is performed during
hysterectomy The study compares the effect of bilateral salpingectomy associated with
conservative hysterectomy on ovarian function to the standard hysterectomy with conservation
of both ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation,
complications, quality of life.

impact of treatments on ovarian reserve are tested by measuring AMH at baseline and 3 days,
6 weeks and 6, 12 months after surgeries.

quality of life is also assessed at these time points, with a questionnaire (Women Health
Questionnaire WHQ).

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months)

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:



France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:




Start Date:

July 2012

Completion Date:

November 2016

Related Keywords:

  • Genital Diseases, Female
  • Hysterotomy; Affecting Fetus
  • Leiomyomata Uteri
  • Adenomyosis, Endometriosis
  • Dysfunctional Uterine Bleeding
  • Cervical Dysplasia
  • Uterine Prolapse
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia
  • Endometriosis
  • Genital Diseases, Female
  • Hemorrhage
  • Leiomyoma
  • Myofibroma
  • Metrorrhagia
  • Prolapse
  • Uterine Hemorrhage
  • Uterine Prolapse