UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026041 |
|---|---|
| Receipt number | 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 | 2020/08/18 08:30:45 |
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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 |
| Obstetrics 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 | Nao |
| Middle name | |
| Last name | Suzuki |
Organization
St. Marianna University of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
2168511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
TEL
044-977-8111
nao@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Suzuki |
Organization
St. Marianna University of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
2168511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
TEL
044-977-8111
Homepage URL
nao@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University of Medicine
Institute
Department
Personal name
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
IRB of St. Marianna University
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki 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
| 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
| 2017 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2040 | 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
| 2017 | Year | 02 | Month | 07 | Day |
Last modified on
| 2020 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029926
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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