UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of thyroid autoantibodies and ovarian reserve in infertile women
Title of the study (Brief title)	OR and thyroid autoantibodies
Region	Japan

Condition
Condition	Infertile women
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analysis for influence of thyroid autoantibodies on ovarian reserve using serum AMH levels in infertile women
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum AMH levels
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	20 years-old <=
Age-upper limit	50 years-old >
Gender	Female
Key inclusion criteria	Infertile women
Key exclusion criteria	History of ovarian surgery PCOS Endocrine diseases Others
Target sample size	150

Research contact person
Name of lead principal investigator	Akira Iwase
Organization	Nagoya University Hospital
Division name	Maternal and Perinatal Medicine
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2261
Email	akiwase@med.nagoya-u.ac.jp

Public contact
Name of contact person	Akira Iwase
Organization	Nagoya University Hospital
Division name	Maternal and Perinatal Medicine
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2261
Homepage URL
Email	akiwase@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Nagoya University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 04 Month 10 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2011 Year 11 Month 25 Day
Anticipated trial start date	2011 Year 11 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	Retrospectively registered

Management information
Registered date	2017 Year 04 Month 10 Day
Last modified on	2019 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030885