UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015669 |
|---|---|
| Receipt number | R000018194 |
| Scientific Title | Study to Determine the Optimal Starting Dose of FSH in a Low- Dose-Stepup Regimen |
| Date of disclosure of the study information | 2014/11/17 |
| Last modified on | 2018/12/06 16:20:00 |
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Basic information
Public title
Study to Determine the Optimal Starting Dose of FSH in a Low- Dose-Stepup Regimen
Acronym
Study to Determine the Optimal Starting Dose of FSH in a Low- Dose-Stepup Regimen
Scientific Title
Study to Determine the Optimal Starting Dose of FSH in a Low- Dose-Stepup Regimen
Scientific Title:Acronym
Study to Determine the Optimal Starting Dose of FSH in a Low- Dose-Stepup Regimen
Region
| Japan |
Condition
Condition
WHO group II ovarian failure (first-grade amenorrhea, oligomenorrhea, or anovulatory cycle), luteal phase insufficiency, or unexplained infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is designed to evaluate the efficacy and safety of a low-dose-stepup regimen of recombinant human FSH (Gonalef Pen) with BMI-based starting dose levels.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of subjects whose dominant follicles grow to a mean diameter of 18 mm within 10 days after starting FSH administration and the cumulative FSH dose needed to reach this endpoint
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
At 50 IU if BMI is less than 20 kg/m2,Follicular growth will be monitored by transvaginal ultrasonography (US) on the 7th day of administration and every 2-4 days thereafter. In the absence of sufficient follicular growth, the FSH dose may be increased every 7 days in steps of 12.5 IU. A total of 4 dose escalations will be permitted.
When the mean diameter of dominant follicle has reached 18 mm as confirmed by transvaginal US, a single dose of 5,000 IU of hCG will be administered to induce ovulation.
Interventions/Control_2
At 62.5 IU if BMI is not less than 20 kg/m2,Follicular growth will be monitored by transvaginal ultrasonography (US) on the 7th day of administration and every 2-4 days thereafter. In the absence of sufficient follicular growth, the FSH dose may be increased every 7 days in steps of 12.5 IU. A total of 4 dose escalations will be permitted.
When the mean diameter of dominant follicle has reached 18 mm as confirmed by transvaginal US, a single dose of 5,000 IU of hCG will be administered to induce ovulation.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) WHO group II ovarian failure (first-grade amenorrhea, oligomenorrhea, or anovulatory cycle), luteal phase insufficiency, or unexplained infertility
2) Written informed consent to the study given before enrollment
Key exclusion criteria
1) WHO group I ovarian failure (second-grade [central] amenorrhea)
2) WHO group III ovarian failure (ovarian amenorrhea)
3) Hyperprolactinemia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MInoru Irahara |
Organization
Tokushima University Hospital
Division name
Head of the Department of Obstetrics and Gynecology
Zip code
Address
2-50-1, Kuramoto, Tokushima 770-8503, Japan
TEL
0886313111
irahara@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiya Matsuzaki |
Organization
Tokushima University Hospital
Division name
Sub-Head of the Department of Obstetrics and Gynecology
Zip code
Address
2-50-1, Kuramoto, Tokushima 770-8503, Japan
TEL
0886313111
Homepage URL
matsuzaki.toshiya@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology,Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Merck Serono Co.,Ltd
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
Address
Tel
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
| 2014 | Year | 11 | Month | 17 | 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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 12 | Day |
Last modified on
| 2018 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018194
