Oocyte Freezing for Fertility Preservation in Benign Ovarian Tumors (OFBOT)

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ClinicalTrials.gov Identifier: NCT03823833

Recruitment Status : Not yet recruiting

First Posted : January 31, 2019

Last Update Posted : August 26, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

University Hospital, Lille

Study Description

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.

Condition or disease
Endometriosis Dermoid Cyst Mucinous Cyst

Study Design

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Study Type :	Observational
Estimated Enrollment :	100 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Systematic Proposal of Fertility Preservation by Oocyte Freezing in Case of Benign Ovarian Tumors With High Risk of Recurrence
Estimated Study Start Date :	December 2020
Estimated Primary Completion Date :	December 2022
Estimated Study Completion Date :	December 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Ovarian cancer

MedlinePlus related topics: Ovarian Cancer

Genetic and Rare Diseases Information Center resources: Ovarian Cancer

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Number of mature oocytes eligible for cryopreservation [ Time Frame: After 15 days of controlled ovarian hyperstimulation (COH) ]

Secondary Outcome Measures :

Percentage of immature or morphologically abnormal oocytes [ Time Frame: Real-time, the day of egg retrieval ]
Number of mature follicles (≥15 mm) and intermediary (10-14 mm) during ovarian stimulation [ Time Frame: The day of HCG triggering at the end of ovarian stimulation ]
Questionnaire on tolerance and complications [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 35 Years (Adult)
Sexes Eligible for Study:	Female
Gender Based Eligibility:	Yes
Gender Eligibility Description:	young women
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Young women with benign ovarian tumors and high risk of further infertility due to surgery

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823833

Contacts

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Contact: Christine Decanter, MD	320445962 ext +33	christine.decanter@chru-lille.fr

Sponsors and Collaborators

University Hospital, Lille

Investigators

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Principal Investigator:	Christine Decanter, MD	University Hospital, Lille

More Information

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Responsible Party:	University Hospital, Lille
ClinicalTrials.gov Identifier:	NCT03823833
Other Study ID Numbers:	2018_48
First Posted:	January 31, 2019 Key Record Dates
Last Update Posted:	August 26, 2020
Last Verified:	August 2020

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University Hospital, Lille:


Oocyte freezing fertility preservation ovarian cysts benign ovarian tumor endometrioma

Additional relevant MeSH terms:

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Cysts Ovarian Neoplasms Dermoid Cyst Endometriosis Neoplasms Pathological Conditions, Anatomical Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases	Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Teratoma Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type

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