Female InfertilityNCT02454829
Follow-up of Ovarian Function in Young Women Who Underwent Ovarian Cortex Cryopreservation
An observational study of Female Infertility, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Evaluation of ovarian function by a questionnaire and by medical file analysis of women and girls who underwent ovarian cortex cryopreservation for fertility preservation between 1997 an 2013 in the investigators' institution in order to evaluate their residual ovarian function. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Female Infertility
- What is being tested?
- questionnaire
- How many people
- 546 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2015to Jan 2016
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All women who underwent ovarian cortex cryopreservation in our institution between 1997 and 2013
Who may be able to join
- women who underwent ovarian cortex cryopreservation in our institution between 1997 and 2013
Who cannot join
- deceased women in this cohort
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up of Ovarian Function in Young Girls and Women Who Underwent Ovarian Cortex Cryopreservation for Fertility Preservation at the Cliniques Universitaires Saint-Luc
Evaluation of ovarian function by a questionnaire and by medical file analysis of women and girls who underwent ovarian cortex cryopreservation for fertility preservation between 1997 an 2013 in the investigators' institution in order to evaluate their residual ovarian function. A second part of the questionnaire concerns these women's satisfaction regarding the procedure.
Read the detailed description
Between 1997 and december 2013, 546 girls and women underwent ovarian cortex cryopreservation in the investigators' institution for fertility preservation. The main indications were the need for a gonadotoxic treatment, repeated ovarian surgery and a genetic risk for premature ovarian failure . These women will be sent a questionnaire concerning their ovarian function since the procedure and a questionnaire about their satisfaction concerning the procedure. Six different questionnaires will be used adapted to the patient's initial indication for cryopreservation and the patient's age at the time of cryopreservation. Complementary data will be obtained by medical file analysis and by contacting the patient's family doctor or gynecologist.
Data will be correlated with received gonadotoxic treatment and surgical interventions.
The purpose of the study is to improve the indications and patient selection for ovarian cortex cryopreservation.
- Conditions
- Female Infertility
- Being tested
- questionnaire
- Keywords
- Ovarian cortex cryopreservation, ovarian function
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
A questionnaire will be send concerning the patient's ovarian function since the cryopreservation procedure i.e: progression of puberty, menstrual cycle, hormonal treatment, desire for pregnancy, occurence of pregnancy, details of pregnancy, need for ART (Artificial Reproductive Techniques), and about the patient's satisfaction concerning the cryopreservation procedure. Data collected will be correlated with treatments received.
| Study group | Role | What they receive |
|---|---|---|
| Adults, gonadotoxic treatment | Women 18 years of age or older who underwent ovarian cortex cryopreservation before gonadotoxic treatment (chemotherapy, radiotherapy) Receives: Other: questionnaire | |
| Girls, gonadotoxic treatment | Girls under 18 years of age who underwent ovarian cortex cryopreservation before gonadotoxic treatment (chemotherapy, radiotherapy) Receives: Other: questionnaire | |
| Adults, ovarian pathology | Women 18 years of age or older who underwent ovarian cortex cryopreservation for an ovarian pathology not requiring gonadotoxic treatment but surgery Receives: Other: questionnaire | |
| Girls, ovarian pathology | Girls under 18 years of age who underwent ovarian cortex cryopreservation for an ovarian pathology not requiring gonadotoxic treatment but surgery Receives: Other: questionnaire | |
| Adults, genetic disorders | Women 18 years of age or older who underwent ovarian cortex cryopreservation in the context of a genetic risk of premature ovarian failure Receives: Other: questionnaire | |
| Girls, genetic disorders | Girls under 18 years of age who underwent ovarian cortex cryopreservation in the context of a genetic risk of premature ovarian failure Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence of ovarian function
Prove of ovarian function will be the occurence of pregnancy, the presence of menstrual cycles without hormonal treatment based on the questionnaire or on biological findings compatible with ovarian function in medical file
Measured: since the cryopreservation procedure (24 up to 216 months)
Secondary outcomes (1)
Satisfaction with the undergone cryopreservation procedure
The questionnaire will evaluate the patient's satisfaction concerning the cryopreservation procedure
Measured: at the time of completion of the questionnaire (24 up to 216 months after the cryopreservation procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- 546 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascale Jadoul, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454829
- Sponsor's protocol ID
- CRYOFONOV01
- Status last verified
- Apr 2016
- First submitted
- 22 Apr 2015
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Ovarian Function in Young Girls and Women Who Underwent Ovarian Cortex Cryopreservation for Fertility Preservation at the Cliniques Universitaires Saint-Luc
- ClinicalTrials.gov ID
- NCT02454829
- Acronym / sponsor ID
- CRYOFONOV01
- Conditions
- Female Infertility
- Keywords
- Ovarian cortex cryopreservation, ovarian function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 May 2015 (estimated)
- 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.
Evaluation of ovarian function by a questionnaire and by medical file analysis of women and girls who underwent ovarian cortex cryopreservation for fertility preservation between 1997 an 2013 in the investigators' institution in order to evaluate their residual ovarian function. A second part of the questionnaire concerns these women's satisfaction regarding the procedure.
Detailed description
Between 1997 and december 2013, 546 girls and women underwent ovarian cortex cryopreservation in the investigators' institution for fertility preservation. The main indications were the need for a gonadotoxic treatment, repeated ovarian surgery and a genetic risk for premature ovarian failure . These women will be sent a questionnaire concerning their ovarian function since the procedure and a questionnaire about their satisfaction concerning the procedure. Six different questionnaires will be used adapted to the patient's initial indication for cryopreservation and the patient's age at the time of cryopreservation. Complementary data will be obtained by medical file analysis and by contacting the patient's family doctor or gynecologist.
Data will be correlated with received gonadotoxic treatment and surgical interventions.
The purpose of the study is to improve the indications and patient selection for ovarian cortex cryopreservation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Adults, gonadotoxic treatment | – | Other: questionnaireWomen 18 years of age or older who underwent ovarian cortex cryopreservation before gonadotoxic treatment (chemotherapy, radiotherapy) |
| Girls, gonadotoxic treatment | – | Other: questionnaireGirls under 18 years of age who underwent ovarian cortex cryopreservation before gonadotoxic treatment (chemotherapy, radiotherapy) |
| Adults, ovarian pathology | – | Other: questionnaireWomen 18 years of age or older who underwent ovarian cortex cryopreservation for an ovarian pathology not requiring gonadotoxic treatment but surgery |
| Girls, ovarian pathology | – | Other: questionnaireGirls under 18 years of age who underwent ovarian cortex cryopreservation for an ovarian pathology not requiring gonadotoxic treatment but surgery |
| Adults, genetic disorders | – | Other: questionnaireWomen 18 years of age or older who underwent ovarian cortex cryopreservation in the context of a genetic risk of premature ovarian failure |
| Girls, genetic disorders | – | Other: questionnaireGirls under 18 years of age who underwent ovarian cortex cryopreservation in the context of a genetic risk of premature ovarian failure |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All women who underwent ovarian cortex cryopreservation in our institution between 1997 and 2013
Key inclusion criteria (1 listed)
- women who underwent ovarian cortex cryopreservation in our institution between 1997 and 2013
Key exclusion criteria (1 listed)
- deceased women in this cohort
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireA questionnaire will be send concerning the patient's ovarian function since the cryopreservation procedure i.e: progression of puberty, menstrual cycle, hormonal treatment, desire for pregnancy, occurence of pregnancy, details of pregnancy, need for ART (Artificial Reproductive Techniques), and about the patient's satisfaction concerning the cryopreservation procedure. Data collected will be correlated with treatments received. | Other | Adults, genetic disorders, Adults, gonadotoxic treatment, Adults, ovarian pathology, Girls, genetic disorders, Girls, gonadotoxic treatment, Girls, ovarian pathology |
Primary outcome
Persistence of ovarian function
Time frame: since the cryopreservation procedure (24 up to 216 months)
Prove of ovarian function will be the occurence of pregnancy, the presence of menstrual cycles without hormonal treatment based on the questionnaire or on biological findings compatible with ovarian function in medical file
1 secondary outcome
Satisfaction with the undergone cryopreservation procedure
Time frame: at the time of completion of the questionnaire (24 up to 216 months after the cryopreservation procedure)
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 15 Apr 2016.
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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.
Pascale Jadoul principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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 Female Infertility, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 1 inclusion and 1 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 15 Apr 2016. 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 Belgium. 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?
Persistence of ovarian function (time frame: since the cryopreservation procedure (24 up to 216 months)). 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 15 Apr 2016.