UMIN-CTR Clinical Trial

Public title

Oocyte cryopreservation for fertility preservation in girls whose fertility is expected to decline

Acronym

Oocyte cryopreservation for fertility preservation in girls whose fertility is expected to decline

Scientific Title

Oocyte cryopreservation for fertility preservation in girls whose fertility is expected to decline

Scientific Title:Acronym

Oocyte cryopreservation for fertility preservation in girls whose fertility is expected to decline

Region

Japan

Condition

Malignant disease, blood diseases, collagen diseases, Turner syndrome, ovarian tumors, and other diseases where ovarian reserve is expected to decline due to the underlying disease or treatment.

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We will perform egg freezing in pediatric patients whose fertility is reduced due to a disease or its treatment, and confirm its effectiveness and safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Evaluate the number of oocytes retrieved, the number of mature oocytes, the number of pregnancies, and the patient's long-term ovarian reserve.
The presence of ovarian hyperstimulation syndrome, infection and abnormal bleeding, and changes in mental status will also be evaluated.

Key secondary outcomes

Short-term and long-term ovarian reserve (AMH, FSH, E2, menstruation, etc.)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

18

years-old

>

Gender

Female

Key inclusion criteria

Patients undergoing treatment that reduces fertility due to malignant diseases, blood disorders, collagen diseases, etc.
In addition, patients who may have reduced fertility due to their constitution or disease, such as Turner syndrome.

Key exclusion criteria

If the attending physician deems it inappropriate
If oocyte cryopreservation is judged to be dangerous due to poor physical condition, blood, or general condition.
When the prognosis is extremely poor
If the person and his or her family do not agree

Target sample size

10

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

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

k-sienbu.mail@marianna-u.ac.jp

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name

Nao Suzuki

Organization

N/A

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

N/A

Name of secondary funder(s)

Organization

St. Marianna University Schol of Medicine

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

聖マリアンナ医科大学病院

Date of disclosure of the study information

2023

Year

11

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

11

Month

21

Day

Date of IRB

Anticipated trial start date

2023

Year

12

Month

01

Day

Last follow-up date

2043

Year

03

Month

21

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

As an evaluation of effectiveness, egg retrieval results, fertilization results, pregnancy and childbirth results will be verified. To evaluate safety, short-term complications (ovarian hyperstimulation syndrome, bleeding, infection, disease exacerbation, etc.) and long-term complications (psychological/psychological problems, disease exacerbation, etc.) will also be evaluated. The validity of this method will also be verified by continuously evaluating ovarian reserve.

Registered date

2023

Year

11

Month

21

Day

Last modified on

2023

Year

11

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060320