UMIN-CTR Clinical Trial

Basic information
Public title	The effect of ovarian tumor surgery on ovarian reserve and construction of treatment strategy for preserving fertility
Acronym	The effect of ovarian tumor surgery on ovarian reserve and construction of treatment strategy for preserving fertility
Scientific Title	The effect of ovarian tumor surgery on ovarian reserve and construction of treatment strategy for preserving fertility
Scientific Title:Acronym	The effect of ovarian tumor surgery on ovarian reserve and construction of treatment strategy for preserving fertility
Region	Japan

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

Objectives
Narrative objectives1	A comparison of changes in serum AMH levels before and after surgery for endometriotic ovarian cysts and benign ovarian tumors by surgery, and whether this could be a predictor of success or failure of spontaneous pregnancy after surgery The purpose of the study is to establish a treatment method that can preserve ovarian function.
Basic objectives2	Others
Basic objectives -Others	Late birth has increased the number of infertile patients and the number of patients undergoing ovarian surgery before pregnancy. The aim is to build a future child-raising strategy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum AMH before operation, 1 month, 6 months and 12 months after operation
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	Patients who visited our hospital for surgery
Key exclusion criteria	Postmenopausal women and women under 20
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Iwase
Organization	Gunma university hospital
Division name	Obstetrics and gynecology
Zip code	3718511
Address	3-39-15, Showa,Maebasi,Gunma
TEL	027-220-8429
Email	akiwase@gunma-u.ac.jp

Public contact
Name of contact person	1st name Mio Middle name Last name Kobayashi
Organization	Gunma university hospital
Division name	Obstetrics and gynecology
Zip code	3718511
Address	3-39-15, Showa,Maebasi,Gunma
TEL	027-220-8429
Homepage URL
Email	mio_bobochan@yahoo.co.jp

Sponsor
Institute	Gunma university
Institute
Department

Funding Source
Organization	BECKMAN COULTER
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Medical Research Ethics Review Committee for Gunma University
Address	3-39-15,Showa,Maebashi,Gunma
Tel	027-220-7111
Email	hitotaisho-ciru@ml.gunma-u.ac.jp

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	2020 Year 02 Month 01 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	Preinitiation
Date of protocol fixation	2019 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date	2020 Year 02 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Serum AMH is measured before surgery, 1 month, 6 months, and 12 months after surgery in patients who visited our outpatient clinic for ovarian surgery. To compare the decrease of serum AMH by the operation method and to evaluate the prognosis prognosis.

Management information
Registered date	2020 Year 01 Month 10 Day
Last modified on	2020 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044619