An interventional study of Suture of the ovarian cortex and No suture of the ovarian cortex in Endometrioma, sponsored by Università degli Studi dell'Insubria. Not yet recruiting at 1 site in Italy. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2021-04-29.
Sponsored by Università degli Studi dell'Insubria · Not applicable, Interventional, and Treatment
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Among 104 studies in Endometriosis with a site in Italy — 27 open to participants now, 32 under way, none of them phase 3. Endometriosis · Italy.
Among the 104 studies in Endometriosis with a site in Italy, this one is the 20th largest by planned enrollment of the 45 interventional ones that give a count, is one of 7 that started in 2023, is one of 26 with no phase, reaches primary completion later than 10 of the 31 other live ones, and was the 30th registered.
921 studies on the registry are indexed under Endometriosis; 267 are open to participants now.
Browse Endometriosis studies →27 of the 104 studies in Endometriosis with a site in Italy are open now. Recruiting first, the newest first:
Casa di Cura Dott. Pederzoli · Sites in Italy
Ages 18+ · Women only
IRCCS Azienda Ospedaliero-Universitaria di Bologna · Sites in Italy
Ages 18–40 · Women only
Casa di Cura Dott. Pederzoli · Sites in Italy
Ages 18–50 · Women only
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Sites in Italy
Ages 18–39 · Women only
IRCCS San Raffaele · Sites in Italy
Ages 18–40 · Women only · Healthy volunteers
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 178 Endometriosis studies recruiting now, 52 (29%) set no upper age limit and 124 (70%) stop at 75 or younger; 18 take children under 18; 39 take healthy volunteers.
This study: 18 Years to 35 Years · female · no healthy volunteers.
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104 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 7 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 67 across 541 interventional studies indexed under Endometriosis.
Median enrollment 84 across the 45 interventional studies, 200 across the 59 observational. Of the 51 that completed or were terminated, 5 (10%) have results posted.
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13 of 104 have an industry lead sponsor. The 10 most frequent:
Università degli Studi dell'Insubria is the lead sponsor of 68 studies on the registry; 8 are open to participants now.
Università degli Studi dell'Insubria has 4 studies filed under Endometriosis — fewer than ten, so there is no comparison to draw.
3 of the studies in Endometriosis with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07590895Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoEffect of FODMAP Diet on Pain, Quality of Life, and Sexual Function in Women With Pelvic Endometriosis and Gastrointestinal Symptoms | 2026-11-15 |
| NCT07260669Gesynta Pharma ABA Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis | 2027-06 |
| NCT06781398IRCCS Azienda Ospedaliero-Universitaria di BolognaRobotic Surgery in the Treatment of Deep Endometriosis: Da Vinci Vs HUGO RAS Comparison | 2027-07 |
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Among the 104 studies in Endometriosis with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas.
Procedure: Suture of the ovarian cortex
Women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.
Procedure: No suture of the ovarian cortex
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).
Laparoscopic enucleation of endometriomas without suture of the ovarian cortex
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
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
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
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
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for May 2023; primary completion for May 2025, 24 months later.
Of 198 non-industry interventional studies with no phase under Endometriosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 44. This study's planned 24 months is close to that.
Counting every sponsor, half of 213 studies reached it within 25 months; a quarter within 13 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Università degli Studi dell'Insubria