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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028909
Receipt No. 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 2019/09/03

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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
Breast surgery Obsterics 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
16 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
Email 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
Email mitutosi@keio.jp

Sponsor
Institute Keio University
Institute
Department

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
Email 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 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 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
2022 Year 10 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 30 Day
Last modified on
2019 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033040

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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