UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041906 |
|---|---|
| Receipt number | R000047748 |
| Scientific Title | Influence of hyaluronan and prolactin supplementation into the recovery/transfer medium on pregnancy outcomes after single frozen blastocyst transfers |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2023/11/29 10:18:31 |
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Basic information
Public title
Influence of hyaluronan and prolactin supplementation into the recovery/transfer medium on pregnancy outcomes after single frozen blastocyst transfers
Acronym
Influence of hyaluronan and prolactin supplementation into the recovery/transfer medium on pregnancy outcomes
Scientific Title
Influence of hyaluronan and prolactin supplementation into the recovery/transfer medium on pregnancy outcomes after single frozen blastocyst transfers
Scientific Title:Acronym
Influence of hyaluronan and prolactin supplementation into the recovery/transfer medium on pregnancy outcomes
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, it has been reported that the blastocyst transfers using a high hyaluronan-containing culture medium (EmbryoGlue: EG) improves pregnancy outcomes. On the other hand, there are reports that the use of EG does not improve pregnancy outcomes; therefore, the effectiveness of EG is still controversial. Our recent studies have shown that recovery culture using EG after the blastocyst thawing improved the outgrowth. The outgrowth ability was further improved by adding prolactin (PRL) to EG. From these results, we hypothesized that the use of EG or PRL-supplemented EG (EGP) for recovery culture and embryo transfer promotes embryo implantation. The purpose of this study is to examine the pregnancy outcomes when EG and EGP are used for recovery culture and embryo transfer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Live birth rate after frozen blastocyst transfers
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Recovery culture and embryo transfers using the embryo culture medium without hyaluronan and prolactin
Interventions/Control_2
Recovery culture and embryo transfers using the embryo culture medium with hyaluronan
Interventions/Control_3
Recovery culture and embryo transfers using the embryo culture medium with hyaluronan and prolactin
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients who undergo the frozen blastocyst transfers
Key exclusion criteria
Patients with repeated implantation failure/recurrent miscarriage
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Kato |
Organization
Kato Ladies Clinic
Division name
General director
Zip code
1600023
Address
7-20-3, Nishishinjuku, Shinjuku, Tokyo, Japan
TEL
0333661073
klc-ctr@towako-kato.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Ezoe |
Organization
Kato Ladies Clinic
Division name
R&D Division
Zip code
1600023
Address
7-20-3, Nishishinjuku, Shinjuku, Tokyo, Japan
TEL
0333661073
Homepage URL
k-ezoe@towako-kato.com
Sponsor or person
Institute
Kato Ladies Clinic
Institute
Department
Personal name
Funding Source
Organization
Not Applicable
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
Institutional Review Board of Kato Ladies Clinic
Address
7-20-3, Nishishinjuku, Shinjuku, Tokyo, Japan
Tel
0333661073
n-aoyama@towako-kato.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
| 2020 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
0
Results
This study was not conducted and discontinued.
Results date posted
| 2023 | Year | 04 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047748
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
