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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004559
Receipt No. R000005447
Scientific Title Study for the adverse effects of infertility treatments on ovarian function in Japan
Date of disclosure of the study information 2010/11/15
Last modified on 2010/11/15

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Basic information
Public title Study for the adverse effects of infertility treatments on ovarian function in Japan
Acronym Study for the adverse effects of infertility treatments on ovarian function in Japan
Scientific Title Study for the adverse effects of infertility treatments on ovarian function in Japan
Scientific Title:Acronym Study for the adverse effects of infertility treatments on ovarian function in Japan
Region
Japan

Condition
Condition Infertility, endometriosis
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To compare the differnce in the unmber of ovum retrieval in IVF (in vitro fertilization) with and without endometriosis
2) To compare the difference in the number of ovum retrieval in the various treatments for endmetriosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of ovum retrieval in IVF
Key secondary outcomes

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
25 years-old <=
Age-upper limit
40 years-old >=
Gender Female
Key inclusion criteria 1) Infertile patients undergoing in vitro fertilization for the first time
2) Patients with menstrual cycle
3) Patients understanding the purpose of the study and with their imformed consent
Key exclusion criteria 1) Patients who have received surgery related to ovarian issues
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Minegishi
Organization Gunma University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 3-39-22 Showa-machi maebashi-shi, gunma 371-8511
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Gunma University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 3-39-22 Showa-machi maebashi-shi, gunma 371-8511
TEL
Homepage URL
Email

Sponsor
Institute Gunma University Graduate School of Medicine
Department of Obstetrics and Gynecology
Institute
Department

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
2010 Year 11 Month 15 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
2010 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design:
prospective cohort study and ambispective cohort study

Statistics analysis:
Wilcoxon test, multivariable regression analysis

Management information
Registered date
2010 Year 11 Month 15 Day
Last modified on
2010 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005447

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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