UMIN-CTR Clinical Trial

Basic information
Public title	Cryopreservation of oocyte as fertility preservation for girls who are expected to have decreased fertility (a case of primary ovarian insufficiency due to precocious puberty)
Acronym	Cryopreservation of oocyte as fertility preservation for girls who are expected to have decreased fertility (a case of primary ovarian insufficiency due to precocious puberty)
Scientific Title	Cryopreservation of oocyte as fertility preservation for girls who are expected to have decreased fertility (a case of primary ovarian insufficiency due to precocious puberty)
Scientific Title:Acronym	Cryopreservation of oocyte as fertility preservation for girls who are expected to have decreased fertility (a case of primary ovarian insufficiency due to precocious puberty)
Region	Japan

Condition
Condition	precocious puberty, primary ovarian insufficiency
Classification by specialty	Obsterics and gynecology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Cryopreserve the oocyte of patients who are expected to lose fertility, leaving the possibility of future pregnancy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of retrieved oocyte
Key secondary outcomes	Complication

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	14 years-old <=
Age-upper limit	14 years-old >=
Gender	Female
Key inclusion criteria	The diagnosis of precocious puberty Loss of fertility
Key exclusion criteria	If the person does not wish
Target sample size	1

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

Public contact
Name of contact person	1st name Seido Middle name Last name Takae
Organization	St. Marianna University School of Medicine
Division name	Department of Obstetrics and Gynecology
Zip code	216-8511
Address	2-16-1 Sugao, Miyamae-ku,Kawasaki city, Kanagawa JAPAN
TEL	044-977-8111
Homepage URL
Email	s2takae@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	none
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	Certified Review oard of St. Marianna University
Address	2-16-1 Sugao, Miyamae-ku,Kawasaki city, 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	聖マリアンナ医科大学病院

Other administrative information
Date of disclosure of the study information	2022 Year 07 Month 12 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	Enrolling by invitation
Date of protocol fixation	2022 Year 05 Month 17 Day
Date of IRB	2022 Year 05 Month 17 Day
Anticipated trial start date	2022 Year 05 Month 17 Day
Last follow-up date	2032 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Oocyte cryopreservation will be performed on only one target case to evaluate its efficacy and safety. The reason is that the patient is a pubertal girl and the disease is precocious puberty. In the future, we plan to consider opportunities for oocyte collection multiple times.

Management information
Registered date	2022 Year 07 Month 12 Day
Last modified on	2022 Year 07 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055105