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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suture | Experimental | Women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas. |
|
| No suture | Sham Comparator | Women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Simone Laganà, M.D. | Contact | +393296279579 | antoniosimone.lagana@asst-settelaghi.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Simone Laganà, M.D. | Università degli Studi dell'Insubria | Principal Investigator |
| Fabio Ghezzi, M.D. | Università degli Studi dell'Insubria | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Filippo Del Ponte" Hospital | Varese | 21100 | Italy |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Randomized Controlled Trial
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Surgeons who perform the surgery will be not masked for the treatment allocation.
Evaluators (sonographers, data analyzers) will be blind for the treatment allocation.
|
| No suture of the ovarian cortex | Procedure | Laparoscopic enucleation of endometriomas without suture of the ovarian cortex |
|
| 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. | 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 |
| Ovarian volume | Evaluation of the ovarian volume calculated using the prolate ellipsoid formula (length x height x width x 0.523) | 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 |
| Jvan Casarin, M.D. |
| Università degli Studi dell'Insubria |
| Principal Investigator |
| Simone Garzon | Università degli Studi dell'Insubria | Principal Investigator |
| D000091662 | Genital Diseases |