UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052361 |
|---|---|
| Receipt number | R000058358 |
| Scientific Title | A Comparative Study of Pregnancy Rates Before and After Insurance Coverage of Assisted Reproductive Treatment (ART) in Japan |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2025/04/01 14:09:09 |
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Basic information
Public title
A Comparative Study of Pregnancy Rates Before and After Insurance Coverage of Assisted Reproductive Treatment (ART) in Japan
Acronym
A Comparative Study of Pregnancy Rates Before and After Insurance Coverage of Assisted Reproductive Treatment (ART) in Japan
Scientific Title
A Comparative Study of Pregnancy Rates Before and After Insurance Coverage of Assisted Reproductive Treatment (ART) in Japan
Scientific Title:Acronym
A Comparative Study of Pregnancy Rates Before and After Insurance Coverage of Assisted Reproductive Treatment (ART) in Japan
Region
| Japan |
Condition
Condition
infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this retrospective case-control study is to compare the pregnancy outcomes of first-time embryo transfers performed before insurance coverage with those performed after insurance coverage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Continuing pregnancy rate at 9 weeks gestation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
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 | Maneuver |
Interventions/Control_1
Privately funded embryo transfers, which have been performed prior to insurance coverage (drugs used vary from institution to institution). In this study, Proginova was used for estrogen replacement and Duphaston for progesterone replacement.
Interventions/Control_2
Embryo transfers using insurance-approved drugs performed after insurance coverage. In this study, Estrana Tape, Estrogel, or Jurina was used for estrogen replacement, and Utrogestan, Lutinas, or Wankrinon for progesterone replacement.
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
| 43 | years-old | > |
Gender
Female
Key inclusion criteria
(1) under 43 years of age (based on the conditions for ART insurance coverage in Japan), (2) first embryo transfer cycle, (3) frozen-thawed embryo transfer performed with endometrial adjustment using hormone replacement therapy, (3) no previous pregnancy, (4) no uterine malformation (endometrial polyp, bicornuate uterus, uterine myoma/hysterosalpingomyosis > 5 cm, endometrial thinning (5) No known chromosomal abnormality; (6) Written consent for participation in clinical research confirmed.
Key exclusion criteria
(1) cases who requested PGT-A, and (2) cases who withdrew their consent to participate in clinical research through procedures after participation in the study.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Komiya |
Organization
HORAC Grand Front Osaka Clinic
Division name
Gynecology
Zip code
530-0011
Address
Grand Frront Osaka Tower B 15F, 3-1, Ofuka-cho, Kita-ku, Osaka city, Osaka, Japan
TEL
0636778824
komiya0703@gmail.com
Public contact
Name of contact person
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Komiya |
Organization
HORAC Grand Front Osaka Clinic
Division name
Gynecology
Zip code
530-0011
Address
Grand Frront Osaka Tower B 15F, 3-1, Ofuka-cho, Kita-ku, Osaka city, Osaka, Japan
TEL
0636778824
Homepage URL
komiya0703@gmail.com
Sponsor or person
Institute
HORAC Grand Front Osaka Clinic
Institute
Department
Personal name
Funding Source
Organization
None
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
HORAC Grand Front Osaka Clinic
Address
Grand Frront Osaka Tower B 15F, 3-1, Ofuka-cho, Kita-ku, Osaka city, Osaka, Japan
Tel
0636778824
komiya0703@gmail.com
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 | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1182
Results
No significant difference was observed in the rates of clinical pregnancy between the insurance-covered treatment group and the self-pay treatment group (OR=0.95, [95% CI: 0.66-1.36], p=0.76).
Results date posted
| 2023 | Year | 09 | Month | 30 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The release of results will be delayed due to ongoing manuscript preparation.
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
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058358
