Oocyte Freezing for Fertility Preservation in Benign Ovarian Tumors

Endometriosis Clinical Trial

— OFBOT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03823833
• Other study ID #: 2018_48
• Status: Recruiting
• Start date: July 28, 2021
• Est. completion date: December 2022

Study information

• Verified date: December 2022
• Source: University Hospital, Lille
• Contact: Christine Decanter, MD
• Phone: 320445962
• Email: christine.decanter[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cysts
• Dermoid Cyst
• Endometriosis
• Mucinous Cyst
• Ovarian Neoplasms

Locations

Country	Name	City	State
France	Hop Jeanne de Flandre Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

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