UMIN-ICDS Clinical Trial

Public title

Prospective Cohort study of Female Oncofertility in Osaka

Acronym

PCOF-Osaka

Scientific Title

Prospective Cohort study of Female Oncofertility in Osaka

Scientific Title:Acronym

PCOF-Osaka

Region

Japan

Condition

Adolescent and young adult women with newly diagnosed cancer, requiring anticancer treatment

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Female patients undergoing anticancer treatment are at elevated risk of adverse ovarian outcomes including infertility.
Objectives of this research is to develop new Japanese evidences about correlation between anticancer treatment and diminished ovarian reserve.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Primary outcomes are serum antimullerian hormone at fertility preservation (baseline), 1 and 2 years later.
Odds ratio, 95% CI and p value are calculated using multivariate multiple regression analysis.

Key secondary outcomes

Secondary outcomes are serum FSH level, antral follicle counts, and amenorrhea at fertility preservation (baseline), 1 and 2 years later.
Odds ratio, 95% CI and p value are calculated about serum FSH level and antral follicle counts using multivariate multiple regression analysis.
Odds ratio, 95% CI and p value are calculated about amenorrhea using logistic regression analysis.

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

18

years-old

<=

Age-upper limit

43

years-old

>

Gender

Female

Key inclusion criteria

1. Female cancer patients undergoing fertility preservation before or during anticancer treatment.
2. Ages at fertility preservation are over 18 and under 43.
3. Patients who can agree with this research.

Key exclusion criteria

1. Patients undergoing ovarian cryopreservation.
2. Patients who are judged by the investigator to be ineligible to participate in this research.

Target sample size

300

Name of lead principal investigator

1st name	Ken-Ichirou
Middle name
Last name	Morishige

Organization

Osaka General Medical Center

Division name

Reproductive medicine center

Zip code

558-8558

Address

3-1-56, Mandaihigashi, Sumiyoshi-ku, Osaka-shi, Osaka-fu

TEL

06-6692-1201

Email

moriken@gh.opho.jp

Name of contact person

1st name	Satoshi
Middle name
Last name	Kubota

Organization

Osaka General Medical Center

Division name

Reproductive medicine center

Zip code

558-8558

Address

3-1-56, Mandaihigashi, Sumiyoshi-ku, Osaka-shi, Osaka-fu

TEL

06-6692-1201

Homepage URL

Email

satosikubota1982@gh.opho.jp

Institute

Osaka General Medical Center

Institute

Department

Personal name

Ken-Ichirou Morishige

Organization

During funding application

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Review Board Osaka University Hospital

Address

Kenkyushien-kakari, kyoikukenkyushien-ka, Osaka University Hospital, Saisentaniryo-innovation center-to 4F, 2-2, Yamadaoka, Suita-shi, Osaka-hu

Tel

06-6210-8296

Email

rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs

YES

Study ID_1

G23218(33)

Org. issuing International ID_1

Ethical Review Board Osaka University Hospital

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

妊孕性温存療法実施機関：全て大阪府
1. 大阪大学医学部附属病院
2. 大阪医科薬科大学病院
3. 関西医科大学附属病院
4. HORACグランフロント大阪クリニック
5. IVF大阪クリニック
6. IVFなんばクリニック
7. 大阪急性期・総合医療センター
8. 谷口病院
9. なかむらレディースクリニック
10. 近畿大学病院
11. 府中のぞみクリニック
12. 越田クリニック

がん治療病院：全て大阪府
1. 大阪国際がんセンター
2. 大阪大学医学部附属病院
3. 市立豊中病院
4. 大阪医科薬科大学病院
5. 関西医科大学附属病院
6. 市立東大阪医療センター
7. 八尾市立病院
8. 近畿大学病院
9. 国立病院機構大阪南医療センター
10. 大阪労災病院
11. 堺市立総合医療センター
12. 市立岸和田市民病院
13. 和泉市立総合医療センター
14. 大阪公立大学医学部附属病院
15. 大阪市立総合医療センター
16. 大阪赤十字病院
17. 国立病院機構大阪医療センター
18. 大阪急性期・総合医療センター
19. 市立池田病院
20. 愛仁会高槻病院
21. 松下記念病院
22. りんくう総合医療センター
23. 淀川キリスト教病院
24. 北野病院
25. 住友病院
26. 大阪警察病院
27. 大阪母子医療センター
28. ベルランド総合病院
29. 大阪ブレストクリニック

Date of disclosure of the study information

2024

Year

02

Month

05

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

Enrolling by invitation

Date of protocol fixation

2023

Year

11

Month

28

Day

Date of IRB

2023

Year

11

Month

28

Day

Anticipated trial start date

2024

Year

02

Month

05

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

None

Registered date

2024

Year

01

Month

26

Day

Last modified on

2024

Year

01

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060754