UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038032 |
|---|---|
| Receipt number | R000042916 |
| Scientific Title | Elucidation of the Influence of Female Microbiota on Fertility Outcome |
| Date of disclosure of the study information | 2019/09/18 |
| Last modified on | 2023/03/22 13:06:39 |
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Basic information
Public title
Elucidation of the Influence of Female Microbiota on Fertility Outcome
Acronym
Elucidation of the Influence of Female Microbiota on Fertility Outcome
Scientific Title
Elucidation of the Influence of Female Microbiota on Fertility Outcome
Scientific Title:Acronym
Elucidation of the Influence of Female Microbiota on Fertility Outcome
Region
| Japan |
Condition
Condition
sterility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the impact of a woman's bacterial flora on the prognosis of infertility treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bacterial flora during infertility treatment
Key secondary outcomes
Cumulative on-going rate and on-going transition (change over time) after bacterial flora testing and intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
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 |
Interventions/Control_1
Anti-biotic agent
Interventions/Control_2
probiotic preparations
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
(1) failure of implantation after at least two consecutive high-quality embryo transfers in fresh or frozen-thaw cycles, (2) possession of at least one high-quality embryo at the time of study inclusion, (3) no current smoking habit by either couple and (4) written consent for study participation.
Key exclusion criteria
(1) performing PGT-A, (2) diagnosed with antiphospholipid antibody syndrome, (3) using sperm retrieved by TESE for any reason, (4) morphological abnormalities in the myometrium or endometrium evident on transvaginal ultrasonography at the inclusion, and (5) having a chocolate cyst of 3 cm or more. (6) A history of antibiotics, steroids, immunosuppressive drugs, or vaginal suppositories within two weeks of endometrial tissue collection.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Komiya |
Organization
HORAC grand front Osaka Clinic
Division name
medical office
Zip code
530-0011
Address
Grand Front Osaka Tower B 15th Floor, 3 -1 Ofuka-cho, Kita-ku, Osaka-shi, Osaka
TEL
06-6377-8824
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
medical office
Zip code
530-0011
Address
Grand Front Osaka Tower B 15th Floor, 3 -1 Ofuka-cho, Kita-ku, Osaka-shi, Osaka
TEL
06-6377-8824
Homepage URL
komiya0703@gmail.com
Sponsor or person
Institute
Sunkeikai Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sunkaky Medical Corporation
Address
1 -1 -14, Nagata Higashi, Higashiosaka-shi, Osaka
Tel
06-4308-8824
komiya0703@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
2019-38
Org. issuing International ID_1
Sunkeikai Medical Corporation IRB
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
HORACグランフロント大阪クリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 18 | 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
499
Results
The ratio of the yield of bacterial DNA to that of human DNA was evaluated using a proprietary algorithm and classified as Normal, Abnormal, Moderate low biomass, Ultra low biomass, or Inappropriate specimens. The primary outcome was the on-going pregnancy, and the fertility outcomes of each group were compared.Results of a prospective cohort of 499 cases included in the analysis showed that Ultra low biomass was a significant coefficient preventing on-going pregnancy (OR, 0.28; 95% CI, 0.08-0.91, P=0.04).
Results date posted
| 2023 | Year | 03 | Month | 22 | Day |
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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After entry into this study, follow-up will be performed until the end of pregnancy, and perinatal and neonatal outcomes will be investigated.
Management information
Registered date
| 2019 | Year | 09 | Month | 18 | Day |
Last modified on
| 2023 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042916
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
