UMIN-CTR Clinical Trial

Basic information
Public title	A study of the therapeutic efficacy of PICSI in patients with repeated miscarriages after embryo transfer and patients with teratozoospermia
Acronym	A study of the therapeutic efficacy of PICSI
Scientific Title	A prospective randomized controlled trial of the therapeutic efficacy of PICSI in patients with repeated miscarriage after embryo transfer and patients with teratozoospermia
Scientific Title:Acronym	A study of the therapeutic efficacy of PICSI
Region	Japan

Condition
Condition	Repeated miscarriage patients after embryo transfer, Teratozoospermic patients
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to randomly divide patients with repeated miscarriages or teratozoospermia into ICSI and PICSI groups, compare their clinical outcomes, confirm the therapeutic efficacy of PICSI, and clarify the indications for PICSI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Day3 grade 1 embryo rate
Key secondary outcomes	Fertilization rate, Blastocysto development rate, Clinical pregnancy rate, Abortion rate, HBA score

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Sperm selection using hyaluronic acid
Interventions/Control_2	Sperm selection based on morphology
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Repeated miscarriages or implantation failure after embryo transfer. Teratozoospermic patients. Patients who have given written consent to participate in this study.
Key exclusion criteria	Male infertile patients eligible for TESE/TESA/PESA. Patients undergoing ICSI using frozen thawed sperm. Patients who used study reagents within 30 days prior to egg retrieval. Patients who cannot have given written consent to participate in this study.
Target sample size	132

Research contact person
Name of lead principal investigator	1st name TAKETOSHI Middle name Last name SHIMIZU
Organization	Shibakoen Kamiyama Clinic
Division name	Laboratory
Zip code	1050014
Address	Daiyu Building 1F shiba 2-9-10 minatoku Tokyo
TEL	0364145641
Email	s-kamiyamaclinic.ivflabo@outlook.jp

Public contact
Name of contact person	1st name TAKETOSHI Middle name Last name KAMIYAMA
Organization	Shibakoen Kamiyama Clinic
Division name	General director
Zip code	1050014
Address	Daiyu Building 1F shiba 2-9-10 minatoku Tokyo
TEL	0364145641
Homepage URL
Email	s-kamiyamaclinic@jcom.home.ne.jp

Sponsor
Institute	Shibakoen Kamiyama Clinic
Institute
Department

Funding Source
Organization	Shibakoen Kamiyama Clinic
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 Shibakoen Kamiyama Clinic
Address	105-0014 Daiyu Building 1F shiba 2-9-10 minatoku Tokyo
Tel	0364145641
Email	s-kamiyamaclinic.ivflabo@outlook.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	2022 Year 04 Month 20 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	Preinitiation
Date of protocol fixation	2022 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2022 Year 05 Month 09 Day
Last follow-up date	2026 Year 05 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	2022 Year 04 Month 20 Day
Last modified on	2022 Year 04 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054213