UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039122 |
|---|---|
| Receipt number | R000044619 |
| Scientific Title | The effect of ovarian tumor surgery on ovarian reserve and construction of treatment strategy for preserving fertility |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2020/01/10 18:37:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Obstetrics 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
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
mio_bobochan@yahoo.co.jp
Sponsor or person
Institute
Gunma university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044619
