UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028966
Receipt number R000033147
Scientific Title Factors associated with ovarian reserve following cesarean section
Date of disclosure of the study information 2017/09/01
Last modified on 2020/05/17 12:02:17

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Basic information

Public title

Factors associated with ovarian reserve following cesarean section

Acronym

Factors associated with ovarian reserve following cesarean section

Scientific Title

Factors associated with ovarian reserve following cesarean section

Scientific Title:Acronym

Factors associated with ovarian reserve following cesarean section

Region

Japan


Condition

Condition

Repeat cesarean section

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify the factors associated with ovarian reserve following cesarean section

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Antimullerian hormone at three month after cesarean section

Key secondary outcomes

antral follicle count


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Patient who undergo cesarean section due to previous cesarean section

Key exclusion criteria

Some conditions not suitable for this study

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Kohyama

Organization

Tokyo Metropolitan Tama Medical Center

Division name

Department of Obstetrics and Gynecology

Zip code


Address

2-8-29 Musashidai Fuchushi Tokyo, Japan

TEL

042-323-5111

Email

Akira_kouyama@tmhp.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tsutomu Ida

Organization

Tokyo Metropolitan Tama Medical Center

Division name

Department of Obstetrics and Gynecology

Zip code


Address

2-8-29 Musashidai Fuchushi Tokyo, Japan

TEL

042-323-5111

Homepage URL


Email

t-ida@umin.ac.jp


Sponsor or person

Institute

Tokyo Metropolitan Tama Medical Center

Institute

Department

Personal name



Funding Source

Organization

Office of metropolitan hospital management

Organization

Division

Category of Funding Organization

Local Government

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

2017 Year 09 Month 01 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

Completed

Date of protocol fixation

2017 Year 09 Month 01 Day

Date of IRB

2017 Year 03 Month 06 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is a prospective observational study to evaluate ovarian reserve following cesarean section at three month after the surgery. We especially focus on the association with salpingectomy.


Management information

Registered date

2017 Year 09 Month 01 Day

Last modified on

2020 Year 05 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033147


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name