Endometriosis Clinical Trial
— OFBOTOfficial title:
Systematic Proposal of Fertility Preservation by Oocyte Freezing in Case of Benign Ovarian Tumors With High Risk of Recurrence
NCT number | NCT03823833 |
Other study ID # | 2018_48 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 28, 2021 |
Est. completion date | December 2022 |
Benign ovarian cysts are frequent during women's life. They are diagnosed with pelvic pain or fortuitously during an ultra-sonographic exam. In case of persistence,a surgery will be necessary to identify the nature of the cyst and assess its benignity. In some case, cysts are recurrent and multiple surgeries are needed leading to a significant risk of ovarian damage by follicular depletion. Oocyte cryopreservation is no longer considered as an experimental technique of Fertility Preservation since 2013 as it has been recognized to be efficient and safe. According to reproductive medicine scientific committees and the French ethic law, fertility preservation has to be proposed in every situation of infertility risk. To date, there is no cohort study dedicated to fertility preservation by oocyte freezing in this specific subgroup of patients. The purpose of the study is to prospectively evaluate the oocyte number and quality after controlled ovarian hyperstimulation in patients with recurrent ovarian cysts.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - women with benign ovarian tumor with high risk of recurrence, i-e, endometrioma, dermoid cysts or mucinous cysts. - women with previous surgery and/or high risk of ovarian damage: bilateral cysts, cyst diameter higher than 5 cms - Having a social insurance - Able to give an informed consent Exclusion Criteria: - Borderline tumors - Undetectable AMH levels - Personal history of thrombo-embolic events - pregnancy |
Country | Name | City | State |
---|---|---|---|
France | Hop Jeanne de Flandre Chu Lille | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of mature oocytes eligible for cryopreservation | After 15 days of controlled ovarian hyperstimulation (COH) | ||
Secondary | Percentage of immature or morphologically abnormal oocytes | Real-time, the day of egg retrieval | ||
Secondary | Number of mature follicles (=15 mm) and intermediary (10-14 mm) during ovarian stimulation | The day of HCG triggering at the end of ovarian stimulation | ||
Secondary | Questionnaire on tolerance and complications | A systematic telephone interview will be carried out 48 to 72 hours after the oocyte puncture to judge the tolerance of the procedure. | One week after the egg retrieval |
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