![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | ||
Condition | Patients with premature ovarian insufficiency (POI) and severe ovarian dysfunction | |
Classification by specialty |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 |
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 |
|
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 |
|
||||||
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete |
|
||||||
Date analysis concluded |
|
Other | |
Other related information | None |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |