UMIN-CTR Clinical Trial

Basic information
Public title	The evaluation for usefulness of dienogest to prevent decline of ovarian reserve by cystectomy for endometriomas
Acronym	The evaluation for usefulness of dienogest to prevent decline of ovarian reserve by cystectomy for endometriomas.
Scientific Title	The evaluation for usefulness of dienogest to prevent decline of ovarian reserve by cystectomy for endometriomas
Scientific Title:Acronym	The evaluation for usefulness of dienogest to prevent decline of ovarian reserve by cystectomy for endometriomas.
Region	Japan

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

Objectives
Narrative objectives1	To investigate effects of administration of dienogest before and after laparoscopic surgery for endometriomas on the ovarian reserve
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum concentrations of AMH, 2 and 1 months before operation, 1,2,6,12 months after operation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	dienogest 2mg/day, 8 weeks before operation and 8 weeks after operation
Interventions/Control_2	buserelin acetate 1.8mg/every 4 weeks, twice before operation and twice after operation
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	42 years-old >=
Gender	Female
Key inclusion criteria	unilateral or bilateral endometrioma(s) with 4-cm diameter at least
Key exclusion criteria	Hisory of ovarian surgery, History of hormonal therapy within 6 months before surgery, Complication with other endocrinological diseases
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Satoko Osuka
Organization	Nagoya University Hospital
Division name	Maternal and Perinatal Medicine
Zip code
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2261
Email	satokoosuka@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Satoko Osuka
Organization	Nagoya University Hospital
Division name	Maternal and Perinatal Medicine
Zip code
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	0527442261
Homepage URL
Email	satokoosuka@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine, Department of Obstetrics and Gynecology
Institute
Department

Funding Source
Organization	Nagoya University Hospital
Organization
Division
Category of Funding Organization	Other
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	2015 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Terminated
Date of protocol fixation	2015 Year 10 Month 01 Day
Date of IRB	2015 Year 11 Month 19 Day
Anticipated trial start date	2016 Year 03 Month 05 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

Management information
Registered date	2015 Year 08 Month 06 Day
Last modified on	2020 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021492