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

August 24, 2020 updated by: University Hospital, Lille

Systematic Proposal of Fertility Preservation by Oocyte Freezing in Case of Benign Ovarian Tumors With High Risk of Recurrence

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of immature or morphologically abnormal oocytes
Time Frame: Real-time, the day of egg retrieval
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
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.
One week after the egg retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Christine Decanter, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

August 26, 2020

Last Update Submitted That Met QC Criteria

August 24, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018_48

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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