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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03823833
Acronym
OFBOT
Enrollment
82
Registered
2019-01-31
Start date
2021-07-28
Completion date
2025-04-04
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermoid Cyst, Endometriosis, Mucinous Cyst

Keywords

Oocyte freezing, fertility preservation, ovarian cysts, benign ovarian tumor, endometrioma

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.

Interventions

None listed

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of mature oocytes eligible for cryopreservationAfter 15 days of controlled ovarian hyperstimulation (COH)

Secondary

MeasureTime frameDescription
Percentage of immature or morphologically abnormal oocytesReal-time, the day of egg retrieval
Number of mature follicles (≥15 mm) and intermediary (10-14 mm) during ovarian stimulationThe day of HCG triggering at the end of ovarian stimulation
Questionnaire on tolerance and complicationsOne week after the egg retrievalA systematic telephone interview will be carried out 48 to 72 hours after the oocyte puncture to judge the tolerance of the procedure.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026