UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062447 |
|---|---|
| Receipt number | R000071431 |
| Scientific Title | Ovarian Tissue Cryopreservation and Autologous Transplantation for Fertility Preservation in Young Patients with Cancer or Immune Diseases and in Patients with Premature Ovarian Insufficiency |
| Date of disclosure of the study information | 2026/08/03 |
| Last modified on | 2026/08/03 14:39:39 |
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Basic information
Public title
A Study of Freezing and Reimplanting a Patient's Own Ovarian Tissue to Preserve Future Fertility
Acronym
Ovarian Tissue Freezing and Reimplantation Study
Scientific Title
Ovarian Tissue Cryopreservation and Autologous Transplantation for Fertility Preservation in Young Patients with Cancer or Immune Diseases and in Patients with Premature Ovarian Insufficiency
Scientific Title:Acronym
Ovarian Tissue Cryopreservation and Autologous Transplantation Study
Region
| Japan |
Condition
Condition
Malignant neoplasms and immune diseases associated with a high risk of fertility impairment, and premature ovarian insufficiency
Classification by specialty
| Obstetrics and Gynecology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of ovarian tissue cryopreservation and autologous transplantation for fertility preservation in patients with malignant neoplasms or immune diseases whose treatment is associated with a high risk of fertility impairment, and in patients with premature ovarian insufficiency. The primary outcome is the live birth rate after autologous ovarian tissue transplantation. Clinical pregnancy, ovarian graft function, perioperative complications, neonatal outcomes, and effects on the underlying disease will also be evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of participants who deliver a live-born infant among those who undergo autologous ovarian tissue transplantation, assessed through the end of follow-up.
Key secondary outcomes
1. Clinical pregnancy rate after autologous ovarian tissue transplantation, defined by confirmation of a gestational sac.
2. Incidence and severity of perioperative complications associated with ovarian tissue harvesting and autologous transplantation, assessed within 60 days after each procedure.
3. Ovarian graft function after transplantation, assessed by ovulation, serum hormone levels, basal body temperature, and ultrasonographic findings.
4. Neonatal outcomes, including sex, birth weight, chromosomal abnormalities, and congenital anomalies.
5. Presence and severity of symptoms associated with ovarian insufficiency after transplantation.
6. Recurrence of the underlying disease during follow-up.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Within 60 days after enrollment, laparoscopic unilateral oophorectomy will, in principle, be performed under general anesthesia.
The ovarian cortex will be cut into tissue fragments approximately 10 x 10 mm in size and 1 mm in thickness and cryopreserved using the vitrification method.
If oocytes are retrieved by follicular aspiration, they will also be cryopreserved using the vitrification method.
After completion of treatment for the underlying disease, cryopreserved ovarian tissue will be thawed and transplanted laparoscopically if the physician treating the underlying disease determines that transplantation is permissible and the patient wishes to undergo the procedure.
In principle, orthotopic transplantation onto the surface of the remaining ovary will be performed.
If no residual ovary is present, heterotopic transplantation will be performed at a site such as the retroperitoneum near the ovary. Retransplantation of the remaining cryopreserved tissue may be performed as needed.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 43 | years-old | > |
Gender
Female
Key inclusion criteria
Aged under 43 years at the time of informed consent for ovarian tissue cryopreservation.
Has a malignant neoplasm, hematologic malignancy, immune disease, or other condition whose treatment is associated with a high risk of fertility impairment, or has premature ovarian insufficiency, and wishes to undergo fertility preservation.
Has no ovarian lesion associated with the underlying disease.
Is medically fit to undergo oophorectomy.
Has a reasonable prospect of cure and long-term survival from the underlying disease.
Written informed consent has been obtained from the patient or a legally acceptable representative. Assent will be obtained from minors whenever possible.
Key exclusion criteria
Oophorectomy is expected to interfere with treatment of the underlying disease.
The investigator considers the patient unsuitable for participation in the study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hidemichi |
| Middle name | |
| Last name | Watari |
Organization
Hokkaido University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
0608648
Address
North 14, West 5, Kita-Ku, Sapporo, Hokkaido
TEL
+81-117065941
watarih@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Mitamura |
Organization
Hokkaido University Hospital
Division name
Department of Gynecology
Zip code
0608648
Address
North 14, West 5, Kita-Ku, Sapporo, Hokkaido
TEL
+81-117065941
Homepage URL
takami@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital
Address
North 14, West 5, Kita-Ku, Sapporo, Hokkaido
Tel
+81-117067636
crjimu@huhp.hokudai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2046 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 03 | Day |
Last modified on
| 2026 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071431
