EndometriosisOFBOTNCT03823833
Oocyte Freezing for Fertility Preservation in Benign Ovarian Tumors
An observational study of Endometriosis and Dermoid Cyst, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Endometriosis, Dermoid Cyst, Mucinous Cyst
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2021to 4 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Young women with benign ovarian tumors and high risk of further infertility due to surgery
Who may be able to join
- 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
Who cannot join
- Borderline tumors
- Undetectable AMH levels
- Personal history of thrombo-embolic events
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Endometriosis, Dermoid Cyst, Mucinous Cyst
- Keywords
- Oocyte freezing, fertility preservation, ovarian cysts, benign ovarian tumor, endometrioma
- Medical subject headings
- Endometriosis, Dermoid Cyst, Mucocele, Ovarian Cysts
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mature oocytes eligible for cryopreservation
Measured: After 15 days of controlled ovarian hyperstimulation (COH)
Secondary outcomes (3)
Percentage of immature or morphologically abnormal oocytes
Measured: Real-time, the day of egg retrieval
Number of mature follicles (≥15 mm) and intermediary (10-14 mm) during ovarian stimulation
Measured: The day of HCG triggering at the end of ovarian stimulation
Questionnaire on tolerance and complications
A systematic telephone interview will be carried out 48 to 72 hours after the oocyte puncture to judge the tolerance of the procedure.
Measured: One week after the egg retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start28 Jul 2021
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Decanter, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823833
- Sponsor's protocol ID
- 2018_48
- Acronym
- OFBOT
- Status last verified
- Dec 2025
- First submitted
- 28 Jan 2019
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Proposal of Fertility Preservation by Oocyte Freezing in Case of Benign Ovarian Tumors With High Risk of Recurrence
- ClinicalTrials.gov ID
- NCT03823833
- Acronym / sponsor ID
- OFBOT / 2018_48
- Conditions
- Endometriosis, Dermoid Cyst, Mucinous Cyst
- Keywords
- Oocyte freezing, fertility preservation, ovarian cysts, benign ovarian tumor, endometrioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young women with benign ovarian tumors and high risk of further infertility due to surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Borderline tumors
- Undetectable AMH levels
- Personal history of thrombo-embolic events
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of mature oocytes eligible for cryopreservation
Time frame: After 15 days of controlled ovarian hyperstimulation (COH)
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Decanter, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Dermoid Cyst, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of mature oocytes eligible for cryopreservation (time frame: After 15 days of controlled ovarian hyperstimulation (COH)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.