UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035469 |
|---|---|
| Receipt number | R000040024 |
| Scientific Title | Evaluation of treatment with progesterone in controlled ovarian stimulation for patients undergoing IVF/ICSI cycles to prevent ovulation: a randomized clinical trial |
| Date of disclosure of the study information | 2019/01/07 |
| Last modified on | 2022/01/13 16:02:14 |
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Basic information
Public title
Evaluation of treatment with progesterone in controlled ovarian stimulation for patients undergoing IVF/ICSI cycles to prevent ovulation: a randomized clinical trial
Acronym
MPA study
Scientific Title
Evaluation of treatment with progesterone in controlled ovarian stimulation for patients undergoing IVF/ICSI cycles to prevent ovulation: a randomized clinical trial
Scientific Title:Acronym
MPA study
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of medroxyprogesterone acetate (MPA) is equal to GnRH antagonist for preventing lutenizing hormone surges in controlled ovarian hyperstimulation cycles and to investigate the clinical outcomes and endocrinological characteristics during its usage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence of ovulation before oocyte retrieval
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
10mg of MPA (medroxyprogesterone) oral intake daily for 10 days
Interventions/Control_2
0.25mg of GnRHantagonist injection subcutaneously daily for 1 to 3 days
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
| 43 | years-old | > |
Gender
Female
Key inclusion criteria
Patients who will undergo IVF treatments by controlled ovarian hyperstimulation with AMH level 1 ng/ml or higher
Key exclusion criteria
1 Patients with ovulatory disturbance caused by reduced hypothalamic or pituitary activity
2 Patients who can not use GnRH-agonist nasal spray for triggering final oocyte maturation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eri Okamoto |
Organization
Hanabusa Womens' clinic
Division name
Docter
Zip code
Address
7F 1-1-2 Sannomiya-cho Chuo-ku Kobe city Hyogo
TEL
078-392-8723
okamoto@hanabusaclinic.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eri Okamoto |
Organization
Hanabusa Womens' clinic
Division name
Docter
Zip code
Address
7F 1-1-2 Sannomiya-cho Chuo-ku Kobe city Hyogo
TEL
078-392-8723
Homepage URL
okamoto@hanabusaclinic.com
Sponsor or person
Institute
Hanabusa Womens' clinic
Institute
Department
Personal name
Funding Source
Organization
Hanabusa Womens' clinic
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
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
英ウィメンズクリニック
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 07 | Day |
Last modified on
| 2022 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040024
