UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049268 |
|---|---|
| Receipt number | R000056085 |
| Scientific Title | Clinical effect of a weight loss program for female infertility patients |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2024/04/26 16:53:44 |
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Basic information
Public title
Clinical effect of a weight loss program for female infertility patients
Acronym
Clinical effect of a weight loss program for female infertility patients
Scientific Title
Clinical effect of a weight loss program for female infertility patients
Scientific Title:Acronym
Clinical effect of a weight loss program for female infertility patients
Region
| Japan |
Condition
Condition
Female infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of a weight loss program on ovarian function and clinical outcomes in assisted reproductive technology among female infertility patients with a body mass index of 23 or higher.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
anti-Mullerian hormone (AMH) after a weight loss program
Key secondary outcomes
HOMA-R, HbA1c, triglyceride, HDL cholesterol, LDL cholesteroll, FSH, maturation rate of retrieved oocytes, fertilization rate, good blastocyst rate, euploid blastocyst rate, clinical pregnancy rate, miscarriage rate, live birth rate before and after the program
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Weight loss program including exercise therapy and diet therapy for 3 months
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
| Not applicable |
Gender
Female
Key inclusion criteria
Female patients with a BMI of 23 or higher who visited fertility clinic
Key exclusion criteria
Those who cannot obtain consent, or those who are deemed unsuitable by the research director/co-investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomomoto |
| Middle name | |
| Last name | Ishikawa |
Organization
Reproduction Clinic Osaka
Division name
Reproduction Clinic Osaka
Zip code
530-0011
Address
15F, Grand Front Osaka Tower A, 4-20 Ofuka-cho, Kita-ku, Osaka 530-0011 Japan
TEL
06-6136-3344
tishikawa@reposaka.jp
Public contact
Name of contact person
| 1st name | Tomomoto |
| Middle name | |
| Last name | Ishikawa |
Organization
Reproduction Clinic Osaka
Division name
Reproduction Clinic Osaka
Zip code
530-0011
Address
15F, Grand Front Osaka Tower A, 4-20 Ofuka-cho, Kita-ku, Osaka 530-0011 Japan
TEL
06-6136-3344
Homepage URL
tishikawa@reposaka.jp
Sponsor or person
Institute
Reproduction Clinic Osaka
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
Reproduction Clinic Tokyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Reproduction Clinic Osaka
Address
15F, Grand Front Osaka Tower A, 4-20 Ofuka-cho, Kita-ku, Osaka 530-0011 Japan
Tel
06-6136-3344
tishikawa@reposaka.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
リプロダクションクリニック大阪（大阪府）/ Reproduction Clinic Osaka (Osaka)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The effect of a weight loss program for infertile women in Japan is still unclear. In this study, we conducted a weight loss program including exercise and diet therapy for 3 months for female infertile patients with a BMI of 23 or higher, and compared the ovarian function and reproductive outcomes before and after the program to investigate the efficacy of a weight loss program.
Management information
Registered date
| 2022 | Year | 10 | Month | 19 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056085
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
