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Suture of the Ovary After Enucleation of Ovarian Endometrioma

ConditionEndometrioma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorUniversità degli Studi dell'Insubria

About this trial

Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of ectopic endometrial-like tissue outside the uterine cavity.

According to the most updated guidelines of the European Society of Human Reproduction and Embryology (ESHRE), infertile women with endometriomas smaller than 3 cm should be addressed directly to Assisted Reproduction Technology (ART); conversely, for infertile women with endometriomas larger than 3 cm, enucleation of ovarian endometriomas could be considered in order to improve reproductive outcomes (both spontaneous and ART pregnancy rate).

To date, literature data do not allow to draw a firm conclusion about the best strategy to reduce ovarian damage during enucleation of ovarian endometriomas: in particular, investigators still lack robust evidence in order to choose between suturing the ovary or not after the enucleation.

In this scenario, the aim of our the study will be to compare functional outcomes of the ovary in a group of women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas (cases) and a group of women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women affected by one primary (no recurrent) monolateral ovarian endometrioma, with maximum diameter between 5 and 10 cm, undergoing laparoscopic enucleation by stripping technique;

Normal AFC at the enrollment (baseline).

Disqualifiers

Any other disease;

Bilateral endometriomas;

Deep infiltrating endometriosis;

No previous pelvic surgery (even not gynecological);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Suture of the ovarian cortex

    Procedure/Surgery

    Suture of the ovarian cortex after laparoscopic enucleation of endometriomas, using one single monofilament suture material, continuous suture technique with maximum 5 transfixion of the ovarian cortex and intracorporeal knots only (no extracorporeal knots).

  • No suture of the ovarian cortex

    Procedure/Surgery

    Laparoscopic enucleation of endometriomas without suture of the ovarian cortex

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: SutureExperimental treatment 1 intervention
Group B: No sutureSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Antral Follicle Count (AFC)

AFC will be evaluated on day 3 of the cycle by a transvaginal ultrasound. Initially the ovarian volume of both the ovaries is calculated. Further the number of small antral follicles in both the ovaries is measured. These follicles could vary in size from 2-10 mm.

Time frame
Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery

Secondary outcomes

1

Pulsatility index, evaluated by Doppler flowmetry, of the ovarian artery

Evaluation of the pulsatility index (PI; minimum: 0; maximum: 7; higher values represent a better outcome) of the ovarian artery.

Time frame
Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
2

Resistive index, evaluated by Doppler flowmetry, of the ovarian artery

Evaluation of the resistive index (RI minimum: 0; maximum: 3; higher values represent a worse outcome) of the ovarian artery.

Time frame
Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
3

Ovarian volume

Evaluation of the ovarian volume calculated using the prolate ellipsoid formula (length x height x width x 0.523)

Time frame
Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Università degli Studi dell'Insubria

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: