UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020614
Receipt number R000023795
Scientific Title Unfertilized oocyte cryopreservation for fertility preservation of young women in cancer
Date of disclosure of the study information 2016/01/18
Last modified on 2018/01/19 13:24:20

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Basic information

Public title

Unfertilized oocyte cryopreservation for fertility preservation of young women in cancer

Acronym

Unfertilized oocyte cryopreservation of young women in cancer

Scientific Title

Unfertilized oocyte cryopreservation for fertility preservation of young women in cancer

Scientific Title:Acronym

Unfertilized oocyte cryopreservation of young women in cancer

Region

Japan


Condition

Condition

Malignant disease

Classification by specialty

Medicine in general Gastroenterology Pneumology
Endocrinology and Metabolism Hematology and clinical oncology Nephrology
Clinical immunology Surgery in general Gastrointestinal surgery
Chest surgery Endocrine surgery Breast surgery
Obstetrics and Gynecology Pediatrics Dermatology
Oto-rhino-laryngology Orthopedics Urology
Radiology Oral surgery Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Assess the safety and efficacy of unfertilized oocyte cryopreservation. Furthermore, aim at the establishment as the fertility preservation technology.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Achievement rate of unfertilized oocyte cryopreservation
Viability rate, fertilization rate and cleavage rate after thawing
Pregnancy rate and live birth rate per embryo transfer

Key secondary outcomes



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 Maneuver

Interventions/Control_1

After controlled ovarian stimulation, oocytes are retrieved by ultrasound-guided transvaginal aspiration and cryopreserved
Period: routine ovarian stimulation
Desage of medicine: different among indibidials
Number of times: 1-2 times of oocyte pick up

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

42 years-old >=

Gender

Female

Key inclusion criteria

Long-term survival is anticipated
18 years or older
42 years or younger

Key exclusion criteria

An agreement is not obtained
Patient for whom the start of therapy may be significantly delayed for this study
Patient who is judged to be inappropriate for this study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisashi Narahara

Organization

Oita Medical University

Division name

Department of Obstetrics and Gynecology

Zip code


Address

1-1 Idaigaoka, Hasama-machi, Yufu city, Oita

TEL

097-586-5922

Email

sanka@oita-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasushi Kawano

Organization

Oita Medical University

Division name

Department of Obstetrics and Gynecology

Zip code


Address

1-1 Idaigaoka, Hasama-machi, Yufu city, Oita

TEL

097-586-5922

Homepage URL


Email

kawayas@oita-u.ac.jp


Sponsor or person

Institute

Oita University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2016 Year 01 Month 18 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

2015 Year 11 Month 20 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 29 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

2016 Year 01 Month 18 Day

Last modified on

2018 Year 01 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023795


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name