UMIN-CTR Clinical Trial

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	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
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	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	2021 Year 10 Month 12 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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