UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049677 |
|---|---|
| Receipt number | R000056563 |
| Scientific Title | Investigation of infertility treatment outcomes in patients with premature ovarian insufficiency |
| Date of disclosure of the study information | 2022/12/05 |
| Last modified on | 2022/12/02 19:47:17 |
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Basic information
Public title
Investigation of infertility treatment outcomes in patients with premature ovarian insufficiency
Acronym
Investigation of infertility treatment outcomes in patients with premature ovarian insufficiency
Scientific Title
Investigation of infertility treatment outcomes in patients with premature ovarian insufficiency
Scientific Title:Acronym
Investigation of infertility treatment outcomes in patients with premature ovarian insufficiency
Region
| Japan |
Condition
Condition
Premature ovarian insufficiency
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In assisted reproductive medicine, anti-mullerian hormone (AMH) is widely used as an indicator of ovarian reserve. Although a woman's age is the most important factor affecting fertility outcomes, there have been reports suggesting a correlation with AMH levels in cases of premature ovarian insufficiency(POI). The purpose of this study is to estimate the factors that contribute to the failure to achieve pregnancy in patients with POI by accumulating cases of POI and comparing the results of infertility treatment according to the cause of the POI.
Basic objectives2
Others
Basic objectives -Others
The study design is a retrospective multi-institutional, observational study, in which data will be collected on patients who underwent their first IVF/ICSI procedure between January 1, 2021 and December 31, 2021, and who had AMH less than 1.1 ng/mL.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical pregnancy rate per IVF/ICSI treatment cycle by cause of POI
Key secondary outcomes
Type of fertility drugs, dosage, number of eggs retrieved, number of fertilized eggs, number of embryos transferred, embryo grade, production rate
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Patients who started their first IVF/ICSI treatment cycle between January 1, 2021 and December 31, 2021.(The start date of the treatment cycle is the start date of regulated ovarian stimulation, or the start date of menstruation in the case of natural cycles.)
2) Patients whose AMH concentration is less than 1.1 ng/mL within 6 months prior to IVF/ICSI treatment.
Key exclusion criteria
Patients who are deemed inappropriate for inclusion in the program by a physician's judgment
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Iwase |
Organization
Gunma university hospital
Division name
Department of Obstetrics & Gynecology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8429
akiwase@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Iwase |
Organization
Department of Gunma university hospital
Division name
Obstetrics & Gynecology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8429
Homepage URL
akiwase@gunma-u.ac.jp
Sponsor or person
Institute
Gunma university hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Akita University Graduate School of Medicine ,Department of Obstetrics and Gynecology
Asada Ladies Clinic
Kansai Medical University Hospital, Department of Obstetrics and Gynecology
Keio University School of Medicine ,Department of Obstetrics and Gynecology
Saitama Medical School Hospital ,Department of Obstetrics and Gynecology
Saitama Medical School General Medical Center ,Department of Obstetrics and Gynecology
Jichi Medical University ,Department of Obstetrics and Gynecology
Shimane University School of Medicine Center for Comprehensive Perinatal Maternal and Child Health Care
Sugiyama Obstetrics and Gynecology Clinic
St. Marianna University School of Medicine ,Department of Obstetrics and Gynecology
Tokyo Medical University ,Department of Obstetrics and Gynecology
The University of Tokyo Hospital ,Department of Women's Medicine and Surgery
Toho University Medical Center Omori Hospital ,Department of Obstetrics and Gynecology
Tokushima University Hospital ,Department of Obstetrics and Gynecology
Nagasaki University Hospital ,Department of Obstetrics and Gynecology
Hyogo University of Medical Science ,Department of Obstetrics and Gynecology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma university
Address
3-39-15 Showa-machi, Maebashi, Gunma
Tel
027-220-8763
hitotaisho-ciru@ml.gunma-u.ac.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
| 2022 | Year | 12 | Month | 05 | Day |
Related information
URL releasing protocol
https://ciru.dept.showa.gunma-u.ac.jp/guidance/storage-sample/pdf/IRB2022-034.pdf
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
https://ciru.dept.showa.gunma-u.ac.jp/guidance/storage-sample/pdf/IRB2022-034.pdf
Management information
Registered date
| 2022 | Year | 12 | Month | 02 | Day |
Last modified on
| 2022 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056563
