臨床研究等提出・公開システム

Date of registration	Aug. 26, 2020
Last modified on	Jan. 05, 2022
Trial ID	jRCT1080225354

Scientific Title	Effect of biotin on blood data
Public Title	Effect of biotin on blood data

Completion Date or Terminated date	Dec. 20, 2021
Actual Enrolled Number	33
Baseline Characteristics	- getting informed consent - apparently healthy - who can take biotin supplements - who can take bloods 7-10mL and 4 times a day - who do not take the supplements and hormone treatment 1 week before the examination
Participant flow	We took the blood 0, 3, 6, 8 hours after taking biotin. We will measure the fertility assay by the assay kit used avidine-biotin system and the assay kit not used avidine-biotin system. There was the control group who did not take biotin.
Adverse events	Adverse events have not occured.
Primary Outcome Measures	At 3 hours after administration of biotin, the values of AMH were flactuated by using the Elecsys, not by using the Lumipulse.
Secondary Outcome Measures	-
Brief summary	Since the Elecys uses biotin for the measurement system, the AMH value would be fluctuated with biotin supplement.
Posting of journal publication
Date of the first journal publication of results	Sept. 27, 2021
URL hyperlink(s) related to results and publications	https://www.shizenkagakusha.co.jp/igakutoyakugaku/backnumber_7810202110.html

Plan to share IPD	No
Plan description	-
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Asada Ladies Clinic
	Address	4-6-17 Meieki Nakamura-ku Nagoya-city Aichi
	Phone Number	+81-52-551-2203
	E-mail Address	-

Contact for Public Queries	Name
	Contact Name for Public Queries	Asada Ladies Clinic
	Address	4-6-17 Meieki Nakamura-ku Nagoya-city Aichi
	Phone Number	+81-52-551-2203
	E-mail Address	-

Recruitment Status	completed

Date of First Enrolment		Dec. 07, 2020
Target Sample Size		30
Study Type		Interventional
Study Design	Study Design	We will take the blood 0, 3, 6, 8 hours after taking biotin. We will measure the fertility assay by the assay kit used avidine-biotin system and the assay kit not used avidine-biotin system. There is the control group who will not take biotin.
Study Design	Objective	diagnostic purpose
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	- getting informed consent - apparently healthy - who can take biotin supplements - who can take bloods 7-10mL and 4 times a day - who do not take the supplements and hormone treatment 1 week before the examination
	Exclusion Criteria	- pregnancy - surgery within 6 months - BMI is less than 18 or more than 30 - under hormone treatment - under IVF treatment
	Minimum Age	No limit
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		-
Intervention(s)		investigational material(s) Generic name etc : Lumipulse INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : - control material(s) Generic name etc : Elecsys INN of investigational material : Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		confirmatory Fertility assays(LH,FSH,AMH,E2,Progesterone,Prolactin,Teststerone)
Secondary Outcome		-

Primary Sponsor	Yoshimasa Asada
Secondary Sponsor	Tomoaki Sato

Name of Funding Organization	Fujirebio Inc.
Name of Research Funding	research funding

Name	IRB at Asada Ladies Clinic
Address	4-6-17 Meieki Nakamura-ku Nagoya-city Aichi
Phone Number	+81-52-551-2203
E-mail Address	-
Status of Review	Approval
Date of Approval	April. 21, 2021

Secondary ID No.	JapicCTI-205450
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
5	Jan. 05, 2022	(this page)	Changes
4	May. 26, 2021	Detail	Changes
3	April. 12, 2021	Detail	Changes
2	Mar. 02, 2021	Detail	Changes
1	Aug. 27, 2020	Detail

List of change history