UMIN-CTR Clinical Trial

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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