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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040360
Receipt No. 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

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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
Obsterics 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
Email 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
Email chikaishii@roseladiesclinic.jp

Sponsor
Institute Rose Ladies Clinic
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)

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045883

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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