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Oocyte Freezing for Fertility Preservation in Benign Ovarian Tumors

NCT ID: NCT03823833

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-28

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Endometriosis Dermoid Cyst Mucinous Cyst

Keywords

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Oocyte freezing fertility preservation ovarian cysts benign ovarian tumor endometrioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Decanter, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Jeanne de Flandre Chu Lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christine Decanter, MD

Role: CONTACT

Phone: 320445962

Email: [email protected]

Other Identifiers

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2018_48

Identifier Type: -

Identifier Source: org_study_id