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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
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 | 2020/09/18 |
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 |
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Condition | ||
Condition | Infertility | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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Results Delayed | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Management information | |||||||
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Last modified on |
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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 |