UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036990 |
|---|---|
| Receipt number | R000042082 |
| Scientific Title | Lactoferrin supplementation for repeated implantation failure patients with uterine/vaginal dysbiosis |
| Date of disclosure of the study information | 2019/06/07 |
| Last modified on | 2022/09/15 17:20:19 |
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Basic information
Public title
Lactoferrin supplementation for repeated implantation failure patients with uterine/vaginal dysbiosis
Acronym
Lactoferrin supplementation for repeated implantation failure patients with uterine/vaginal dysbiosis
Scientific Title
Lactoferrin supplementation for repeated implantation failure patients with uterine/vaginal dysbiosis
Scientific Title:Acronym
Lactoferrin supplementation for repeated implantation failure patients with uterine/vaginal dysbiosis
Region
| Japan |
Condition
Condition
Repeated implantation failure
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate if oral supplementation of 700mg/day lactoferrin contributes to
(i) rise its concentration in circulating blood, endometrial fluid, and vaginal secretion,
(ii) correct the dysbiosis in the uterine/vaginal cavity in patients undergoing repeated implantation failure, and
(iii) improve the pregnancy outcome in these patients.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(i) Measurement of lactoferrin concentration in circulating blood, endometrial fluid, and vaginal secretion
(ii) Microbiota analysis of endometrial fluid, and vaginal secretion
(iii) Reproductive outcome
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Maneuver | Other |
Interventions/Control_1
Oral supplementation of 700mg/day lactoferrin for 28 days or more for infertile patients with a history of repeated implantation failure and collection of circulating blood, endometrial fluid, and vaginal secretion before and after the intervention
Interventions/Control_2
Collection of circulating blood, endometrial fluid, and vaginal secretion from infertile patients undergoing first embryo transfer attempt
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Infertile women requiring artificial reproductive technology
Key exclusion criteria
Infertile women lacking anatomical uterus and/or vagina
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Kitaya |
Organization
Reproduction Clinic Osaka
Division name
IVF Center
Zip code
5300011
Address
Grand Front Osaka, Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL
0661363344
kitaya@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Kitaya |
Organization
Reproduction Clinic Osaka
Division name
IVF Center
Zip code
5300011
Address
Grand Front Osaka, Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL
0661363344
Homepage URL
kitaya@koto.kpu-m.ac.jp
Sponsor or person
Institute
Reproduction Clinic Osaka
Institute
Department
Personal name
Funding Source
Organization
Reproduction Clinic Osaka
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
Reproduction Clinic Osaka
Address
Grand Front Osaka, Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
Tel
0661363344
kitaya@koto.kpu-m.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
| 2019 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35987819/
Number of participants that the trial has enrolled
172
Results
While CE was more prevalent (OR 2.41, 95% CI 1.02-5.63, p = 0.042) in the RIF group (29.1%, n = 117) than in the non-RIF group (14.5%, n = 55), The NLDM rate was similar between the two groups Lactoferrin supplementation improved NLDM in 43.2% of RIF women (n = 37). Within the RIF group, the live birth rate in the subsequent cycles was higher (OR 10.67, 95% CI 1.03 - 110.0, p = 0.046) in women with improved microbiota (57.1%, n = 14) than in those with unimproved microbiota (11.1%, n = 9).
Results date posted
| 2022 | Year | 09 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 07 | Day |
Last modified on
| 2022 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042082
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
