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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03823833
Recruitment Status : Not yet recruiting
First Posted : January 31, 2019
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date January 28, 2019
First Posted Date January 31, 2019
Last Update Posted Date August 26, 2020
Estimated Study Start Date December 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 28, 2019)
Number of mature oocytes eligible for cryopreservation [ Time Frame: After 15 days of controlled ovarian hyperstimulation (COH) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 28, 2019)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oocyte Freezing for Fertility Preservation in Benign Ovarian Tumors
Official Title Systematic Proposal of Fertility Preservation by Oocyte Freezing in Case of Benign Ovarian Tumors With High Risk of Recurrence
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Young women with benign ovarian tumors and high risk of further infertility due to surgery
Condition
  • Endometriosis
  • Dermoid Cyst
  • Mucinous Cyst
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 28, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: young women
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Christine Decanter, MD 320445962 ext +33 christine.decanter@chru-lille.fr
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03823833
Other Study ID Numbers 2018_48
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Not Provided
Investigators
Principal Investigator: Christine Decanter, MD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date August 2020