Turner SyndromeCRYO-X0NCT01410045
Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome
A study testing Ovariectomy in people with Turner Syndrome and Ovarian Insufficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Ovarian insufficiency is common in Turner syndrome related to premature and rapid follicular apoptosis and spontaneous pregnancies are rare in this population. Ovarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian… Read more about this study
- Who is it for?
- Ages 1 year to 25 years, women only
- Conditions the study is for
- Turner Syndrome, Ovarian Insufficiency
- What is being tested?
- Ovariectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- girls aged from 1 to 25 years included,
- with Turner syndrome or mosaic
- patients aged more than 18 will only have ovarian insufficiency dated less than 5 years
- without any severe disease, particularly of cardiovascular type
- whose agreement to participate to the study has been signed by the parents
- whose agreement to participate to the study has been signed by majority age patient
Who cannot join
- girls aged less than one year and over 25 years old
- if any surgery would be contra-indicated
- ovary alone presence
- Well-known infection by HIV, and/or HBV, and/or HCV and/or syphilis TPHA VDRL
- No social coverage affiliate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome : Karyotypic, Clinical and Hormonal Criteria to Screen Patients
Ovarian insufficiency is common in Turner syndrome related to premature and rapid follicular apoptosis and spontaneous pregnancies are rare in this population. Ovarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian insufficiency. This study aims to assess the relevance of ovarian tissue cryopreservation in girls with Turner syndrome. Based on ovarian follicular density as primary outcome and karyotypic, clinical and hormonal markers as secondary outcomes, analysis of the study will allow to select the patients to whom the procedure would benefit the most.
Read the detailed description
Turner syndrome (TS) is characterized by the absence of all or part of a normal second X chromosome and occurs in about 1/2,500 live-born girls. Spontaneous fertility is rare among patients with TS related to premature apoptosis of ovarian follicles. Spontaneous puberty and fertility has been reported mostly in patients with mosaic karyotype or small X deletions.
There is robust evidence that follicles can be observed in ovaries in girls with TS. However, follicular density and quality seems to be largely influenced by karyotype, ovarian morphology and endocrine competence. There are no clear-cut clinical or hormonal markers to assess the ovarian reserve in girls with TS but markers of ovarian function used in women with premature ovarian insufficiency are measured. In TS, it is now fundamental to be able to evaluate the prognosis of the ovarian function and the degree of fertility to provide the relevant information to girls and their parents and to discuss possibilities of motherhood if any.
Ovarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian insufficiency. This study aims to assess the relevance of ovarian tissue cryopreservation in girls with Turner syndrome. Based on ovarian follicular density as primary outcome and karyotypic, clinical and hormonal markers as secondary outcomes, analysis of the study will allow to screen the patients to whom the procedure would benefit the most.
Girls who will be operated will accept to come for a follow-up visit at one and 12 months after the surgery. It is expected to have clinical and hormonal information through a long follow up performed by the referred paediatrician.
Results of the study will allow us to select patients with TS who will benefit the most of this fertility preservation procedure based on karyotypic, clinical and hormonal profile.
- Conditions
- Turner Syndrome, Ovarian Insufficiency
- Being tested
- Ovariectomy
- Keywords
- Turner syndrome, infertility, ovarian insufficiency, ovarian cryopreservation
- Medical subject headings
- Turner Syndrome, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OvariectomyProcedure or surgery
Ovarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian insufficiency.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Ovariectomy Receives: Procedure: Ovariectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the ovarian follicular density
the specific measure is the ovarian follicular density which will allow to Identify criteria, to predict existence or absence of ovarian follicles at the time of the surgery
Measured: at the time of the ovariectomy
Secondary outcomes (1)
measure hormonal markers
measure hormonal markers as FSH, AMH, Inhibine B and estradiol before, at one month and one year after the ovariectomy
Measured: Before the ovariectomy, 1 month and 12 months after the ovariectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startJan 2011
- Primary completion16 Jan 2014
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Turner SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Lise Duranteau, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410045
- Sponsor's protocol ID
- P081204
- Acronym
- CRYO-X0
- Status last verified
- Mar 2026
- First submitted
- 28 Jun 2011
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome : Karyotypic, Clinical and Hormonal Criteria to Screen Patients
- ClinicalTrials.gov ID
- NCT01410045
- Acronym / sponsor ID
- CRYO-X0 / P081204
- Conditions
- Turner Syndrome, Ovarian Insufficiency
- Keywords
- Turner syndrome, infertility, ovarian insufficiency, ovarian cryopreservation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere, URC-CIC Paris Descartes Necker Cochin
- Study start
- Jan 2011
- Primary completion
- 16 Jan 2014 (actual)
- Study completion
- Feb 2031 (estimated)
- First posted
- 4 Aug 2011 (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.
Ovarian insufficiency is common in Turner syndrome related to premature and rapid follicular apoptosis and spontaneous pregnancies are rare in this population. Ovarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian insufficiency. This study aims to assess the relevance of ovarian tissue cryopreservation in girls with Turner syndrome. Based on ovarian follicular density as primary outcome and karyotypic, clinical and hormonal markers as secondary outcomes, analysis of the study will allow to select the patients to whom the procedure would benefit the most.
Detailed description
Turner syndrome (TS) is characterized by the absence of all or part of a normal second X chromosome and occurs in about 1/2,500 live-born girls. Spontaneous fertility is rare among patients with TS related to premature apoptosis of ovarian follicles. Spontaneous puberty and fertility has been reported mostly in patients with mosaic karyotype or small X deletions.
There is robust evidence that follicles can be observed in ovaries in girls with TS. However, follicular density and quality seems to be largely influenced by karyotype, ovarian morphology and endocrine competence. There are no clear-cut clinical or hormonal markers to assess the ovarian reserve in girls with TS but markers of ovarian function used in women with premature ovarian insufficiency are measured. In TS, it is now fundamental to be able to evaluate the prognosis of the ovarian function and the degree of fertility to provide the relevant information to girls and their parents and to discuss possibilities of motherhood if any.
Ovarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian insufficiency. This study aims to assess the relevance of ovarian tissue cryopreservation in girls with Turner syndrome. Based on ovarian follicular density as primary outcome and karyotypic, clinical and hormonal markers as secondary outcomes, analysis of the study will allow to screen the patients to whom the procedure would benefit the most.
Girls who will be operated will accept to come for a follow-up visit at one and 12 months after the surgery. It is expected to have clinical and hormonal information through a long follow up performed by the referred paediatrician.
Results of the study will allow us to select patients with TS who will benefit the most of this fertility preservation procedure based on karyotypic, clinical and hormonal profile.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: OvariectomyOvariectomy |
Who may qualify
- Ages
- 1 year to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- girls aged from 1 to 25 years included,
- with Turner syndrome or mosaic
- patients aged more than 18 will only have ovarian insufficiency dated less than 5 years
- without any severe disease, particularly of cardiovascular type
- whose agreement to participate to the study has been signed by the parents
Key exclusion criteria (5 listed)
- girls aged less than one year and over 25 years old
- if any surgery would be contra-indicated
- ovary alone presence
- Well-known infection by HIV, and/or HBV, and/or HCV and/or syphilis TPHA VDRL
- No social coverage affiliate
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 |
|---|---|---|
| OvariectomyOvarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian insufficiency. | Procedure or surgery | Surgery |
Primary outcome
the ovarian follicular density
Time frame: at the time of the ovariectomy
the specific measure is the ovarian follicular density which will allow to Identify criteria, to predict existence or absence of ovarian follicles at the time of the surgery
1 secondary outcome
measure hormonal markers
Time frame: Before the ovariectomy, 1 month and 12 months after the ovariectomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Lise Duranteau, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovariectomy in people with Turner Syndrome and Ovarian Insufficiency, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
the ovarian follicular density (time frame: at the time of the ovariectomy). 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 30 Mar 2026.