UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040360 |
|---|---|
| Receipt number | R000045883 |
| Scientific Title | Test for the effectiveness of long term stimulation on induction of follicle growth in premature ovarian insufficiency patients |
| Date of disclosure of the study information | 2020/05/11 |
| Last modified on | 2020/05/11 11:26:13 |
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Basic information
Public title
Test for the effectiveness of long term stimulation on induction of follicle growth in premature ovarian insufficiency patients
Acronym
Study for effectiveness of long term ovarian stimulation
Scientific Title
Test for the effectiveness of long term stimulation on induction of follicle growth in premature ovarian insufficiency patients
Scientific Title:Acronym
Study for effectiveness of long term ovarian stimulation
Region
| Japan |
Condition
Condition
Patients with premature ovarian insufficiency (POI) and severe ovarian dysfunction
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The total number of ovarian follicles in women is fixed at birth and the number of available follicles decreases with age. When the number of available follicles are reached less than 1,000, arrest of activation of primordial follicles occurs, resulting in irregular menstruation, amenorrhea and menopause. Menopause is occurred around 50 years of age in most of women. Some women experience irregular menstruation and amenorrhea before the 50 years of age and suffer from ovarian insufficiency and also POI(Primary Ovarian Insufficiency) which refer to natural menopause before the 40 years of age. The patients with POI have been considered to be difficult to conceive their own genetic children. Based on the previous observational studies in patients with ovulation disorder, the suppressing gonatropins with a GnRH-a along with estrogen replacement followed by hMG stimulation may have a potential for the ovulation induction in POI patients.
Therefore, in this study, we evaluate the effectiveness of above ovulation induction method in patients with POI and severe ovarian dysfunction by conducting retrospective observational study for patients who received this ovulation induction under survey of medical chart at our clinic with comparison published data.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The oocyte retrieval rate and the pregnancy rates per patient and per cycle during study period.
Key secondary outcomes
The pregnancy rate and the live birth rate per patient and per cycle during study period.
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1. POI patients
2. Satisfy more than 2 factors among the following criteria.
1)Over 40 years of age
2)Showed poor responses to ovarian stimulation once in the past. (less than 3 oocytes retreival under proper ovarian stimulation)
3)Abnormal ovarian reserve (AFC: <5-7 or AMH:<0.5-1.1 ng/ml)
Key exclusion criteria
1. Patients over reproductive age
2. Patients who refuse to participate this program against the optout for this study
3. Patients judged to be inappropriate for the study by the physicians
Exclude the patients who meet the above any 1,2,3 criteria.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Bunpei |
| Middle name | |
| Last name | Ishizuka |
Organization
Rose Ladies Clinic
Division name
Clinical Treatment
Zip code
158-0082
Address
2-3-18 Todoroki, Setatgaya-ku, Tokyo
TEL
03-3703-0116
ishizuka@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Chikako |
| Middle name | |
| Last name | Ishii |
Organization
Rose Ladies Clinic
Division name
Information and research
Zip code
158-0082
Address
2-3-18 Todoroki, Setagaya-ku, Tokyo
TEL
03-3703-0116
Homepage URL
chikaishii@roseladiesclinic.jp
Sponsor or person
Institute
Rose Ladies Clinic
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Biomedical Ethic Committee of the Rose Ladies Clinic
Address
2-3-18 Todoroki, Setagaya-ku, Tokyo
Tel
03-3703-0116
chikaishii@roseladiesclinic.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 | 05 | Month | 11 | 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
None
Results date posted
| 2020 | Year | 04 | Month | 23 | Day |
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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 05 | Month | 11 | Day |
Last modified on
| 2020 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045883
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| Registered date | File name |
| Research case data | |
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