UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028909 |
|---|---|
| Receipt number | R000033040 |
| Scientific Title | Evaluating the safety and efficacy of oocyte and embryo vitrification for fertility preservation |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2024/09/04 09:24:17 |
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Basic information
Public title
Evaluating the safety and efficacy of oocyte and embryo vitrification for fertility preservation
Acronym
Evaluating the safety and efficacy of oocyte and embryo vitrification for fertility preservation
Scientific Title
Evaluating the safety and efficacy of oocyte and embryo vitrification for fertility preservation
Scientific Title:Acronym
Evaluating the safety and efficacy of oocyte and embryo vitrification for fertility preservation
Region
| Japan |
Condition
Condition
Cancer, Hematologic disease, Immune disorders
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Clinical immunology |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Breast surgery | Obstetrics and Gynecology |
| Pediatrics | Dermatology | Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In the current study, we would conduct oocyte and/or embryo cryopreservation and improve freezing and thawing technique so that we can preserve fertility of patients suffering from cancers and immune disorders.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival rate of oocytes and embryos after freezing and thawing
Key secondary outcomes
Total dose of gonadotropins, Oocytes retrieval number, Total number of mature oocytes, Fertilization rate, Blastocyst development rate, The ratio of embryos available for transfer per oocyte pick up, Implantation rate per embryo transfer, Liver birth rate per oocyte pick-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
| Medicine |
Interventions/Control_1
Patients undergo controlled ovarian stimulation and
in vitro fertilization (IVF) for fertility preservation before or in the course of treatment for primary disease.
Combined therapy: FSH/hMG injection (150-300 IU) per day with GnRH agonist or GnRH antagonist until maturation of follicles, hCG injection (5000-10000 IU) per day when follicles mature. Freezing and thawing kit would be used for cryopreservation of oocytes/ embryos.
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
| 15 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Cancer, hematological disease, or immune disorders.
2) Physicians referral for fertility preservation.
3) The patients who are expected long-term survival.
4) The patients who have the ability to provide written informed consent.
Key exclusion criteria
1. Freezing
1) The patients who cannot realize or obtain informed consent.
2) The patients judged to be inappropriate for the study by the physicians.
3) The case to delay treatments because of fertility preservation.
2. Fertilization, Embryo Transfer
1) Unmarried patients.
2) The patients who are more than 50 years old.
3) The patients undergoing hysterectomies.
4) The patients whose cancers, hematological diseases, or immune disorders have progressed at the
time of embryo transfer.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Mamoru |
| Middle name | |
| Last name | Tanaka |
Organization
Keio University
Division name
Department of Obstetrics and Gynecology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-5363-3819
mtanaka@a6.keio.jp
Public contact
Name of contact person
| 1st name | Mitsutoshi |
| Middle name | |
| Last name | Yamada |
Organization
Keio University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81352633819
Homepage URL
mitutosi@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
Tokyo
Tel
+81352633819
mitutosi@keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://ovarianresearch.biomedcentral.com/articles/10.1186/s13048-023-01250-x
Number of participants that the trial has enrolled
69
Results
Gonadotoxic treatment resulted in fewer oocytes. Although anti-Mullerian hormone levels were lower in the post-gonadotoxic treatment group than in the pre-gonadotoxic treatment group, oocyte maturation rates were higher in the post-gonadotoxic treatment group than in the pre-gonadotoxic group.
Results date posted
| 2023 | Year | 09 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 08 | Month | 10 | Day |
Baseline Characteristics
We conducted a cohort study to evaluate data on FP treatment cycles among patients with cancer or autoimmune disease before and after gonadotoxic treatment at the reproductive unit of Keio University Hospital.
Participant flow
This study was approved by the Institutional Review Board of Keio University School of Medicine (approval number 20170019), and informed consent was obtained from all of the patients who participated in the study.
Adverse events
none in particular
Outcome measures
The primary outcome of the current study was the number of retrieved mature oocytes [metaphase II (MII) oocytes]. The secondary outcomes included the total number of oocytes retrieved, rate of oocyte maturation (number of MII oocytes/ retrieved oocytes), number of vitrified MII oocytes, rate of fertilisation (number of fertilised oocytes/MII oocytes), rate of cleavage development (number of day-3 embryos/ fertilised oocytes), rate of blastocyst development (number of blastocysts/ fertilised oocytes), and number of vitrified embryos.
Plan to share IPD
not applicable
IPD sharing Plan description
not applicable
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 23 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 23 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 23 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 23 | Day |
Other
Other related information
Ongoing.
A report summarizing progress was submitted during FY2023.
Due to the time required to prepare the paper, the research period was extended by two years.
Management information
Registered date
| 2017 | Year | 08 | Month | 30 | Day |
Last modified on
| 2024 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033040
