UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043664 |
|---|---|
| Receipt number | R000049862 |
| Scientific Title | The outcome of Embryo and oocyte and ovarian tissue in JAPAN (2021) |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2025/03/21 11:00:57 |
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Basic information
Public title
The outcome of fertility preservation treatment in JAPAN (2021)
Acronym
The outcome of fertility preservation treatment in JAPAN (2021)
Scientific Title
The outcome of Embryo and oocyte and ovarian tissue in JAPAN (2021)
Scientific Title:Acronym
The outcome of Embryo and oocyte and ovarian tissue in JAPAN (2021)
Region
| Japan |
Condition
Condition
Breast cancer, hematological cancer, and so on
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of the efficacy of fertility preservation treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Live birth rate
Key secondary outcomes
pregnancy rate, the numbers of extracted oocyte, and so on.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 1 | days-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
The patient who underwent embryo, oocyte, or ovarian tissue cryopreservation as fertility preservation treatment.
Key exclusion criteria
The patients who decline to contribute the present study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | NAO |
| Middle name | |
| Last name | SUZUKI |
Organization
St. Marianna University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, JAPAN
TEL
044-977-8111
nao@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | SEIDO |
| Middle name | |
| Last name | TAKAE |
Organization
St. Marianna University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, JAPAN
TEL
044-977-8111
Homepage URL
s2takae@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Health and Welfare Ministry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board of St. Marianna University
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, JAPAN
Tel
044-977-8111
k-sienbu.mail@marianna-u.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/38899000/, https://pubmed.ncbi.nlm.nih.gov/38263596/
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38899000/, https://pubmed.ncbi.nlm.nih.gov/38263596/
Number of participants that the trial has enrolled
1852
Results
During the study period, ET was performed in 417 patients, resulting in a total of 199 babies. 1.7 ECs and 2.2 ETs were performed per patient, resulting in a live birth rate of 21.4% per ET.
In OC, 1237 OCs and 198 OTCs were performed during the study period. In addition, 57 embryo transfers (ETs) using frozen eggs and 12 ovarian tissue transfers (OTTs) were performed. The pregnancy rate per ET using frozen eggs was 26.3%, and the live birth rate (LBR) was 17.5%.
Results date posted
| 2025 | Year | 03 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We conducted a mailed-in questionnaire survey at institutions certified by the Japan Society of Obstetrics and Gynecology to investigate the number of oocyte cryopreservations (OC) and ovarian tissue cryopreservations (OTC) performed from December 2016 to the end of 2020. And, we conducted a detailed investigation of cases in which frozen specimens were used during the investigation period, and made historical comparisons with previous nationwide studies.
This study was a questionnaire survey. The total number of embryo cryopreservation (EC) was investigated between 2014 and 2020. And for patients who underwent ET among study period, details of EC, outcome of ET, number of live births, and mortality were investigated.
Participant flow
We conducted a mailed-in questionnaire survey at institutions certified by the Japan Society of Obstetrics and Gynecology to investigate the number of oocyte cryopreservations (OC) and ovarian tissue cryopreservations (OTC) performed from December 2016 to the end of 2020. And, we conducted a detailed investigation of cases in which frozen specimens were used during the investigation period, and made historical comparisons with previous nationwide studies.
This study was a questionnaire survey. The total number of embryo cryopreservation (EC) was investigated between 2014 and 2020. And for patients who underwent ET among study period, details of EC, outcome of ET, number of live births, and mortality were investigated.
Adverse events
N/A
Outcome measures
We conducted a mailed-in questionnaire survey at institutions certified by the Japan Society of Obstetrics and Gynecology to investigate the number of oocyte cryopreservations (OC) and ovarian tissue cryopreservations (OTC) performed from December 2016 to the end of 2020. And, we conducted a detailed investigation of cases in which frozen specimens were used during the investigation period, and made historical comparisons with previous nationwide studies.
This study was a questionnaire survey. The total number of embryo cryopreservation (EC) was investigated between 2014 and 2020. And for patients who underwent ET among study period, details of EC, outcome of ET, number of live births, and mortality were investigated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2021 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questionnaire sheet will be sent to the institution and hospital which are registered Japan society of Obstetrics and Gynecology, for investigating the numbers of case, and outcome of treatment. Also, the outcome which are already investigated will be include to present study (already we got the permission).
Management information
Registered date
| 2021 | Year | 03 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049862
