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NCT Number: NCT03788720

Suture of the Ovary After Enucleation of Ovarian Endometrioma

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.

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Key information

Conditions

Endometrioma Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

"Filippo Del Ponte" Hospital

Varese, 21100, Italy

Location contact

Antonio Simone Laganà, M.D.

CONTACT

[email protected]

+393296279579

Davide Sturla, M.D.

SUB_INVESTIGATOR

Giulia Bordi, M.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Any other disease;
  • Bilateral endometriomas;
  • Deep infiltrating endometriosis;
  • No previous pelvic surgery (even not gynecological);
  • Any other pharmacologic and non pharmacologic treatment in the previous 3 months (wash-out period);

Treatment and study plan

Suture of the ovarian cortex

Procedure

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

Laparoscopic enucleation of endometriomas without suture of the ovarian cortex

Primary outcomes

  1. Antral Follicle Count (AFC)

    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

    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.

Secondary outcomes

  1. Pulsatility index, evaluated by Doppler flowmetry, 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

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

  2. Resistive index, evaluated by Doppler flowmetry, 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

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

  3. Ovarian volume

    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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Simone Laganà, M.D.

CONTACT

[email protected]

+393296279579

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Registry information

Official study title

Comparison Between Suture of the Ovary Versus no Suture After Enucleation of Ovarian Endometrioma

Acronym: SOAVE-1

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Dec 28, 2018
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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