An interventional study of Ovarian tissue cryopreservation in Fertility Preservation, Ovarian Tissue Cryopreservation and Turner Syndrome, sponsored by Radboud University Medical Center. Active, not recruiting at 1 site in Netherlands. Open to female participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
Among 10 studies in Turner Syndrome with a site in Netherlands — 3 open to participants now, 6 under way, 2 of them phase 3. Turner Syndrome · Netherlands.
Among the 10 studies in Turner Syndrome with a site in Netherlands, this one is one of 3 that started in 2018, is one of 2 with no phase, and was the 4th registered.
125 studies on the registry are indexed under Turner Syndrome; 33 are open to participants now.
Browse Turner Syndrome studies →3 of the 10 studies in Turner Syndrome with a site in Netherlands are open now. Recruiting first, the newest first:
dr. Laura C. G. de Graaff-Herder · Sites in Netherlands
Ages 18+
dr. Laura C. G. de Graaff-Herder · Sites in Netherlands
Ages 18+
dr. Laura C. G. de Graaff-Herder · Sites in Netherlands, Belgium, Spain and 1 more country
Ages 15–20 · Healthy volunteers
A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →
Of the 25 Turner Syndrome studies recruiting now, 8 (32%) set no upper age limit and 14 (56%) stop at 75 or younger; 15 take children under 18; 5 take healthy volunteers.
This study: 2 Years to 18 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 1989; this study’s year is marked. 3 started in 2018.
This study's enrollment of 106 is above the median of 67 across 52 interventional studies indexed under Turner Syndrome.
Median enrollment 86 across the 6 interventional studies, 485 across the 4 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
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5 of 10 have an industry lead sponsor. The 4 most frequent:
Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Radboud University Medical Center has 2 studies filed under Turner Syndrome — fewer than ten, so there is no comparison to draw.
1 of the studies in Turner Syndrome with a site in Netherlands that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04252001dr. Laura C. G. de Graaff-HerderGrowing up With the Young Endocrine Support System (YESS!) | 2026-12-01 |
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Among the 10 studies in Turner Syndrome with a site in Netherlands, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Rationale: Infertility due is a major concern for girls with Turner syndrome (TS) and their parents. Physicians are often asked about possible options to preserve their fertility. However, despite some experimental case reports, clear evidence for fertility preservation in these girls is lacking and many questions remain. Without evidence on the effectiveness of fertility preservation it cannot routinely be offered to girls with TS.
Objective: To investigate the occurrence of live birth in women with TS after ovarian tissue cryopreservation in childhood followed by auto transplantation in adulthood.
Study design: A national multicentre exploratory intervention study
Study population: Girls diagnosed with Turner Syndrome, aged 2-18 years.
Intervention: Ovarian tissue cryopreservation in childhood followed by auto transplantation in adulthood. In order to obtain the ovarian tissue for cryopreservation, all girls must undergo a laparoscopy under general anaesthesia which will be performed in academic/university clinics with paediatric surgery. During the laparoscopic intervention, a unilateral oophorectomy will be performed, thereby leaving the other ovary intact for hormone production, ovulation, spontaneous pregnancies and as an auto transplantation site for cryopreserved-thawed ovarian cortical tissue later on. Furthermore, a small sample of the ovarian cortex will be used to assess the oocyte quality and genetics (e.g. the presence of germ line mosaicism). Oocytes will be karyotyped by using Fluorescence in situ hybridization (FISH). Karyotypic and hormonal data will be collected once at the yearly clinical visit at the paediatric-endocrinologist. Therefore, a buccal swab and one extra blood sample will be taken and evaluated during the routine laboratory evaluation.
In the future, auto transplantation of frozen-thawed ovarian cortex strips will be performed.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The primary objective remains to preserve the fertility of the respective (minor) patient, facing a very high risk of premature ovarian insufficiency (POI) of 95-98%. Disadvantages of participating in this study are the potential risk of complications related to the laparoscopic unilateral oophorectomy and/or the unknown effect on future fertility of these girls. Moreover, the procedure might raise false hope in patients (and/or parents) about the chance of getting pregnant after auto transplantation of cryopreserved-thawed ovarian tissue in the future. However, we attempt to overcome this by extensive and objective information provision by both written materials and face to face counselling.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Contra-indications for cryopreservation (i.e. active , hepatitis-B or hepatitis-C infection)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Ovarian tissue cryopreservation
Laparoscopic unilateral oophorectomy followed by cryopreservation of ovarian cortex tissue
Live birth ratio (LBR) (main outcome)
• Live birth after auto transplantation of cryopreserved-thawed ovarian cortical tissue (i.e. live birth rate or LBR)
Time frame: Up to 3 years after auto transplantation of cryopreserved-thawed ovarian cortical tissue, and up to 45 years after ovarian tissue cryopreservation.
Number of primordial follicles (proximate)
The number of primordial follicles found in the ovarian tissue
Time frame: Within 1 month after ovarian tissue cryopreservation
Patient's age versus LBR
The association between patient's age at cryopreservation and LBR
Time frame: Up to 3 years after auto transplantation of cryopreserved-thawed ovarian cortical tissue, and up to 45 years after ovarian tissue cryopreservation.
Patient's genotype versus LBR
The association between patient's genotype and LBR
Time frame: Up to 3 years after auto transplantation of cryopreserved-thawed ovarian cortical tissue, and up to 45 years after ovarian tissue cryopreservation.
Patient's Anti-Müllerian hormone (AMH) level versus LBR
The association between patient's AMH level at cryopreservation and LBR
Time frame: Up to 3 years after auto transplantation of cryopreserved-thawed ovarian cortical tissue, and up to 45 years after ovarian tissue cryopreservation.
Patient's Follicle-stimulating hormone (FSH) level versus LBR
The association between patient's FSH level at cryopreservation and LBR
Time frame: Up to 3 years after auto transplantation of cryopreserved-thawed ovarian cortical tissue, and up to 45 years after ovarian tissue cryopreservation.
Study participation rate
The willingness of girls with TS to perform a unilateral oophorectomy for fertility preservation (i.e. the study participation rate)
Time frame: Up to 3 years after inclusion
Eligible participants
The number of eligible participants
Time frame: Up to 3 years after inclusion
Age
The age of the participant
Time frame: Up to 3 years after inclusion
Buccal cells versus peripheral lymphocytes
The incidence of somatic mosaicism (i.e. buccal cells versus peripheral lymphocytes)
Time frame: Up to 3 years after inclusion
Ovarian cells versus peripheral lymphocytes
The incidence of germ cell mosaicism (i.e. ovarian cells versus peripheral lymphocytes and buccal cells)
Time frame: Up to 3 years after inclusion
Serum hormone levels
Serum hormone levels (i.e. FSH, Luteinizing hormone (LH), AMH, E2, inhibin B)
Time frame: Up to 3 years after inclusion
Complication rate
The number of complications related to the laparoscopic procedure
Time frame: Up to 1 year after the laparoscopic procedure
Influence of laparoscopic oophorectomy on puberty and/or menarche
The incidence of puberty and/or menarche after laparoscopic oophorectomy
Time frame: Up to 10 years after the laparoscopic procedure
Incidence of spontaneous pregnancies
The incidence of spontaneous pregnancies after laparoscopic oophorectomy
Time frame: Up to 45 years after the laparoscopic procedure
Restoration of ovarian function after auto transplantation of ovarian tissue
The incidence of menstruation cycle recovery after auto transplantation of cryopreserved-thawed ovarian tissue in the future
Time frame: Up to 2 years after auto transplantation of cryopreserved-thawed ovarian cortical tissue
Pregnancies after auto transplantation of ovarian tissue
The incidence of pregnancies after auto transplantation of cryopreserved-thawed ovarian tissue in the future
Time frame: Up to 2 years after auto transplantation of cryopreserved-thawed ovarian cortical tissue
Ongoing pregnancies after auto transplantation of ovarian tissue
The incidence of ongoing pregnancies after auto transplantation of cryopreserved-thawed ovarian tissue in the future
Time frame: Up to 2 years and 3 months after auto transplantation of cryopreserved-thawed ovarian cortical tissue
Miscarriages after auto transplantation of ovarian tissue
The number of miscarriages after auto transplantation of cryopreserved-thawed ovarian tissue in the future
Time frame: Up to 3 years after auto transplantation of cryopreserved-thawed ovarian cortical tissue
Time to pregnancy after auto transplantation of ovarian tissue
Time to pregnancy after auto transplantation of cryopreserved-thawed ovarian tissue in the future
Time frame: Up to 2 years after auto transplantation of cryopreserved-thawed ovarian cortical tissue
Time to live birth after auto transplantation of ovarian tissue
Time to live birth after auto transplantation of cryopreserved-thawed ovarian tissue in the future
Time frame: Up to 3 years after auto transplantation of cryopreserved-thawed ovarian cortical tissue
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started Jan 2018 (actual). Primary completion is estimated for Nov 2071, 646 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center →