UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for infertility due to female reproductive organs
Title of the study (Brief title)	A study for infertility due to female reproductive organs
Region	Japan

Condition
Condition	hydrosalpinx endometriosis uterine fibroid
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate machanism of infertility related to fallopian tube
Basic objectives2	Others
Basic objectives -Others	To elucidate machanism of infertility related to fallopian tube and the impact of intrauterine environment on pregnancy
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Quantitative analysis of inflammatory cytokines in ascites and hydrosalpinx fluid
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Patients who need to undergo operation due to uterine or ovarian disease and have at least one fallopian tube.
Key exclusion criteria	After bilateral salpingectomy
Target sample size	100

Research contact person
Name of lead principal investigator	Hiroshi Uchida
Organization	Keio University
Division name	Obstetrics and Gynecology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	uchida@a5.keio.jp

Public contact
Name of contact person	Kenji Sato
Organization	Keio University
Division name	Obstetrics and Gynecology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	ksato@keio.jp

Sponsor
Institute	Department of Obstetrics and Gynecology, School of Medicine, Keio University
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)

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	2016 Year 01 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 15 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date	2019 Year 01 Month 24 Day
Date of closure to data entry	2019 Year 01 Month 24 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	none

Management information
Registered date	2016 Year 01 Month 22 Day
Last modified on	2019 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023868