Clinical trial NCT03788720: Suture of the Ovary After Enucleation of Ovarian Endometrioma
Official title: Comparison Between Suture of the Ovary Versus no Suture After Enucleation of Ovarian Endometrioma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometrioma
Keywords: Endometrioma
Laparoscopy
Suture
Ovary
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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: 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);

Primary outcomes:
measure: Antral Follicle Count (AFC)
timeFrame: 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:
measure: Pulsatility index, evaluated by Doppler flowmetry, of the ovarian artery
timeFrame: 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
measure: Resistive index, evaluated by Doppler flowmetry, of the ovarian artery
timeFrame: 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
measure: Ovarian volume
timeFrame: 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:
Locations:
city: Varese
country: Italy
facility: "Filippo Del Ponte" Hospital
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Antonio Simone Laganà, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi dell'Insubria
name: Fabio Ghezzi, M.D.
role: STUDY_DIRECTOR
affiliation: Università degli Studi dell'Insubria
name: Jvan Casarin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi dell'Insubria
name: Simone Garzon
role: PRINCIPAL_INVESTIGATOR
References: