UMIN-CTR Clinical Trial

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 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
Email	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
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	IRB of St. Marianna University
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki Kanagawa JAPAN.
Tel	044-977-8111
Email	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
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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