Oocyte Freezing for Fertility Preservation in Benign Ovarian Tumors

Recruiting

• Conditions: Dermoid Cyst; Mucinous Cyst; Endometriosis

• Registration Number: NCT03823833
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-31
• Study Start: 2021-07-28
• Status Verified: 2022-12
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of mature oocytes eligible for cryopreservation	After 15 days of controlled ovarian hyperstimulation (COH)

Secondary Outcome Measures

Name	Time	Method
Percentage of immature or morphologically abnormal oocytes	Real-time, the day of egg retrieval
Questionnaire on tolerance and complications	One week after the egg retrieval	A systematic telephone interview will be carried out 48 to 72 hours after the oocyte puncture to judge the tolerance of the procedure.
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

Trial Locations

Locations (1)

Hop Jeanne de Flandre Chu Lille; 🇫🇷 Lille, France