UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050193 |
|---|---|
| Receipt number | R000056814 |
| Scientific Title | Prospective cohort study of the bio-psycho-social health for the women undergoing IVF-ET |
| Date of disclosure of the study information | 2023/01/31 |
| Last modified on | 2024/04/06 09:19:52 |
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Basic information
Public title
Prospective cohort study of the bio-psycho-social health for the women undergoing IVF-ET
Acronym
Cohort study for women undergoing IVF-ET
Scientific Title
Prospective cohort study of the bio-psycho-social health for the women undergoing IVF-ET
Scientific Title:Acronym
Cohort study for women undergoing IVF-ET
Region
| Japan |
Condition
Condition
Women who undergo IVF-ET
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This prospective cohort study is aimed to explore the impact of IVF-ET on bio-psycho-social health among the Japanese women in the period of 7 months.
Basic objectives2
Others
Basic objectives -Others
Exploratory study
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Biological health: the dysmenorrhea, Psychological health: the SCREENIVF, Social health: the decision-making of life course.
Key secondary outcomes
Biological health: the sexual concerns, Psychological health: the marital relationships scale, Social health: the balancing fertility treatment and work.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Those who meet all four criteria below are eligible;
1) A woman who is to start the transfer cycle of in vitro fertilization-embryo transfer.
2) In this transfer cycle, the embryos created from the patient's own egg and partner's sperm will be used.
3) Prior to this transplant cycle, a woman had experienced unsuccessful pregnancies or abortions twice or more as the results of IVF-ET.
4) A woman can receive web-survey information by e-mail, log in, and answer in Japanese.
Key exclusion criteria
Those who do not meet all four criteria.
Target sample size
538
Research contact person
Name of lead principal investigator
| 1st name | Kouhei |
| Middle name | |
| Last name | Sugimoto |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
International Center for Reproductive Medicine
Zip code
343-8555
Address
2-1-50 Minamikoshigaya, Koshigaya, Saitama, 343-8555 Japan
TEL
048-965-2028
reprostudy@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Tomoe |
| Middle name | |
| Last name | Koizumi |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
International Center for Reproductive Medicine
Zip code
343-8555
Address
2-1-50 Minamikoshigaya, Koshigaya, Saitama, 343-8555 Japan
TEL
048-965-2028
Homepage URL
reprostudy@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Saitama Medical Center
Institute
Department
Personal name
Kouhei Sugimoto
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
KEIAI Reproductive & Endosurgical Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University Saitama Medical Center IRB
Address
2-1-50 Minamikoshigaya, Koshigaya, Saitama, 343-8555 Japan
Tel
048-965-1111
k-shien@dokkyomed.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
| 2023 | Year | 01 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants will login the web-questionnaire-site at the beginning of embryo-transfer cycle, the pregnancy test, three months and six months after the pregnancy test.
Management information
Registered date
| 2023 | Year | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056814
