Oocyte Freezing for Fertility Preservation in Benign Ovarian Tumors

Systematic Proposal of Fertility Preservation by Oocyte Freezing in Case of Benign Ovarian Tumors With High Risk of Recurrence

Sponsors

Lead Sponsor: University Hospital, Lille

Source University Hospital, Lille
Brief Summary

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.

Overall Status Not yet recruiting
Start Date 2020-12-01
Completion Date 2022-12-01
Primary Completion Date 2022-12-01
Study Type Observational
Primary Outcome
Measure Time Frame
Number of mature oocytes eligible for cryopreservation After 15 days of controlled ovarian hyperstimulation (COH)
Secondary Outcome
Measure Time Frame
Percentage of immature or morphologically abnormal oocytes Real-time, the day of egg retrieval
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
Questionnaire on tolerance and complications One week after the egg retrieval
Enrollment 100
Condition
Eligibility

Sampling Method:

Probability Sample

Criteria:

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

Gender:

Female

Gender Based:

Yes

Gender Description:

young women

Minimum Age:

18 Years

Maximum Age:

35 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Christine Decanter, MD Principal Investigator University Hospital, Lille
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Verification Date

2020-08-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym OFBOT
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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