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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041906
Receipt No. 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 2021/03/30

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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
Obsterics 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 Single blind -participants 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 1200

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
Email 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
Email k-ezoe@towako-kato.com

Sponsor
Institute Kato Ladies Clinic
Institute
Department

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
Email 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 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
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
2022 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
2021 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047748

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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