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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026041
Receipt No. R000029926
Scientific Title The safety and effect of embryo cryopreservation for fertility preservation
Date of disclosure of the study information 2017/02/09
Last modified on 2018/08/14

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Basic information
Public title The safety and effect of embryo cryopreservation for fertility preservation
Acronym The safety and effect of embryo cryopreservation for fertility preservation
Scientific Title The safety and effect of embryo cryopreservation for fertility preservation
Scientific Title:Acronym The safety and effect of embryo cryopreservation for fertility preservation
Region
Japan

Condition
Condition Cancer, Hematologic disease,Collagen disease,
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Clinical immunology Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Endocrine surgery Breast surgery
Obsterics and gynecology Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In this study, we conduct embryo cryopreservation for fertility preservation and investigate the influence on primary disease, pregnancy rare of frozen embryo transfer, and safety in pregnancy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The recurrence of primary disease, Newborn anomalies and malformations
Key secondary outcomes Oocytes retrieved, Fertilization rate, Ovarian reserve after treatment of primary disease

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 stimulation and in vitro fertilization(IVF) for fertility preservation before or in the course of treatment for primary disease.
Combined therapy: one FSH/hMG injection(150-450 IU)per day with GnRH agonist or GnRH antagonist until maturation of follicles, one hCG injection (5000-15000 IU)per day when follicles mature.
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
18 years-old <=
Age-upper limit
45 years-old >=
Gender Female
Key inclusion criteria 1)Cancer, hematological disease, or collagen disease patients.
2)The physicians of primary disease make a written request 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)The patients who are not expected long-term survival.
2)The patients who have the previous history of gynecologic malignant diseases (ovarian cancer, cervical adenocarcinoma)
3)The patients who are during the period of pregnancy or the possibility of pregnancy.
4)The patients judged to be inappropriate for the study by the physicians.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nao Suzuki
Organization St. Marianna University of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
TEL 044-977-8111
Email nao@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nao Suzuki
Organization St. Marianna University of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
TEL 044-977-8111
Homepage URL
Email nao@marianna-u.ac.jp

Sponsor
Institute St. Marianna University of Medicine
Institute
Department

Funding Source
Organization St. Marianna University of Medicine
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
Address
Tel
Email

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
2017 Year 02 Month 09 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 
Totally 30 contributors received oocyte pick up before cancer treatment as fertility preservation. Until now, they don't have any side effect. We will follo up them to assess the ling term efficathy and safety.
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
2017 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 07 Day
Last modified on
2018 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029926

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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