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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 : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Endometriosis Dermoid Cyst Mucinous Cyst

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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 : July 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer




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

Secondary Outcome Measures :
  1. Percentage of immature or morphologically abnormal oocytes [ Time Frame: Real-time, the day of egg retrieval ]
  2. 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 ]
  3. 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.



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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

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

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

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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
Genital Diseases, Female
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