UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028909
Receipt number R000033040
Scientific Title Evaluating the safety and efficacy of oocyte and embryo vitrification for fertility preservation
Date of disclosure of the study information 2017/09/01
Last modified on 2024/03/05 13:24:53

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Basic information

Public title

Evaluating the safety and efficacy of oocyte and embryo vitrification for fertility preservation

Acronym

Evaluating the safety and efficacy of oocyte and embryo vitrification for fertility preservation

Scientific Title

Evaluating the safety and efficacy of oocyte and embryo vitrification for fertility preservation

Scientific Title:Acronym

Evaluating the safety and efficacy of oocyte and embryo vitrification for fertility preservation

Region

Japan


Condition

Condition

Cancer, Hematologic disease, Immune disorders

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Clinical immunology
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery Breast surgery Obstetrics and Gynecology
Pediatrics Dermatology Orthopedics

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

In the current study, we would conduct oocyte and/or embryo cryopreservation and improve freezing and thawing technique so that we can preserve fertility of patients suffering from cancers and immune disorders.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Survival rate of oocytes and embryos after freezing and thawing

Key secondary outcomes

Total dose of gonadotropins, Oocytes retrieval number, Total number of mature oocytes, Fertilization rate, Blastocyst development rate, The ratio of embryos available for transfer per oocyte pick up, Implantation rate per embryo transfer, Liver birth rate per oocyte pick-up


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 controlled ovarian stimulation and
in vitro fertilization (IVF) for fertility preservation before or in the course of treatment for primary disease.

Combined therapy: FSH/hMG injection (150-300 IU) per day with GnRH agonist or GnRH antagonist until maturation of follicles, hCG injection (5000-10000 IU) per day when follicles mature. Freezing and thawing kit would be used for cryopreservation of oocytes/ embryos.

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

15 years-old <=

Age-upper limit

45 years-old >=

Gender

Female

Key inclusion criteria

1) Cancer, hematological disease, or immune disorders.
2) Physicians referral 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. Freezing
1) The patients who cannot realize or obtain informed consent.
2) The patients judged to be inappropriate for the study by the physicians.
3) The case to delay treatments because of fertility preservation.

2. Fertilization, Embryo Transfer
1) Unmarried patients.
2) The patients who are more than 50 years old.
3) The patients undergoing hysterectomies.
4) The patients whose cancers, hematological diseases, or immune disorders have progressed at the
time of embryo transfer.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Mamoru
Middle name
Last name Tanaka

Organization

Keio University

Division name

Department of Obstetrics and Gynecology

Zip code

160-8582

Address

35 Shinanomachi Shinjuku-ku, Tokyo 160-8582, Japan

TEL

03-5363-3819

Email

mtanaka@a6.keio.jp


Public contact

Name of contact person

1st name Mitsutoshi
Middle name
Last name Yamada

Organization

Keio University School of Medicine

Division name

Department of Obstetrics and Gynecology

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

+81352633819

Homepage URL


Email

mitutosi@keio.jp


Sponsor or person

Institute

Keio University

Institute

Department

Personal name



Funding Source

Organization

Keio University

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

Keio University School of Medicine

Address

Tokyo

Tel

+81352633819

Email

mitutosi@keio.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

慶應義塾大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

https://ovarianresearch.biomedcentral.com/articles/10.1186/s13048-023-01250-x

Number of participants that the trial has enrolled

64

Results

Gonadotoxic treatment resulted in fewer oocytes. Although anti-Mullerian hormone levels were lower in the post-gonadotoxic treatment group than in the pre-gonadotoxic treatment group, oocyte maturation rates were higher in the post-gonadotoxic treatment group than in the pre-gonadotoxic group.

Results date posted

2023 Year 09 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2023 Year 08 Month 10 Day

Baseline Characteristics

We conducted a cohort study to evaluate data on FP treatment cycles among patients with cancer or autoimmune disease before and after gonadotoxic treatment at the reproductive unit of Keio University Hospital.

Participant flow

This study was approved by the Institutional Review Board of Keio University School of Medicine (approval number 20170019), and informed consent was obtained from all of the patients who participated in the study.

Adverse events

none in particular

Outcome measures

The primary outcome of the current study was the number of retrieved mature oocytes [metaphase II (MII) oocytes]. The secondary outcomes included the total number of oocytes retrieved, rate of oocyte maturation (number of MII oocytes/ retrieved oocytes), number of vitrified MII oocytes, rate of fertilisation (number of fertilised oocytes/MII oocytes), rate of cleavage development (number of day-3 embryos/ fertilised oocytes), rate of blastocyst development (number of blastocysts/ fertilised oocytes), and number of vitrified embryos.

Plan to share IPD

not applicable

IPD sharing Plan description

not applicable


Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2017 Year 08 Month 24 Day

Date of IRB

2017 Year 09 Month 01 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2024 Year 10 Month 23 Day

Date of closure to data entry

2024 Year 10 Month 23 Day

Date trial data considered complete

2024 Year 10 Month 23 Day

Date analysis concluded

2024 Year 10 Month 23 Day


Other

Other related information

Ongoing.
A report summarizing progress was submitted during FY2023.
Due to the time required to prepare the paper, the research period was extended by two years.


Management information

Registered date

2017 Year 08 Month 30 Day

Last modified on

2024 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033040


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name