UMIN-CTR Clinical Trial

Basic information
Public title	Japanese study of the outcome of hormonally controlled FET cycles using OneCrinone as luteal support
Acronym	J-FOCAL study
Scientific Title	Japanese study of the outcome of hormonally controlled FET cycles using OneCrinone as luteal support
Scientific Title:Acronym	J-FOCAL study
Region	Japan

Condition
Condition	Infertility
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether improvement in pregnancy rate by OneCrinone as luteal phase support (LPS) in embryo transfer (ET) after in-vitro fertilization (IVF) is also effective in frozen-thawed embryo transfer (FET) in hormone replacement cycles.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Clinical pregnancy rate per FET
Key secondary outcomes	Biochemical pregnancy rate per FET,Early miscarriage rate,Bleeding rate,Ongoing pregnancy rate,Safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Management of FET schedules
Interventions/Control_2
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	42 years-old >=
Gender	Female
Key inclusion criteria	1)Japanese race 2)Patients wishing to undergo FET 3)Women with transplantable frozen blastocysts (blastocysts classified to grades other than C) who are indicated for FET in hormone replacement cycles 4)Healthy premenopausal woman under 42 years of age at the time of ET and wishing to conceive 5)Normal cervical cytology within 12 months prior to the date of informed consent [cervical cytology: Negative for Intraepithelial Lesion or Malignancy (NILM) or Atypical Squamous Cells of Undetermined Significance (ASC-US) and Human Papillomavirus (HPV) negative]. The test results can be reported by patients themselves (results must be recorded in the medical record). If results are not available, or if cytology was not performed during this period, cervical cytology and HPV test, if needed, will be performed during the screening period. 6)Written informed consent for participation obtained from the patient 7)First-time participation in this study
Key exclusion criteria	1)Natural ovulation may be expected (mature follicles observed). 2)History of recurrent pregnancy loss (defined as 3 or more previous spontaneous abortions) 3)History of 3 or more consecutive cancelled or failed (no clinical pregnancy) ET cycles. 4)Underwent ovarian stimulation using clomiphene citrate in the previous cycle and not having menstruation following oocyte retrieval. 5)Abnormal hemorrhage of the reproductive tract of undetermined origin 6)Any contraindication to being pregnant and/or carrying a pregnancy to term 7)Endometriosis, uterine myoma, adenomyosis uteri, or uterine polyps requiring treatment 8)Extra-uterine pregnancy within the last 3 months prior to the date of informed consent 9)Ovarian enlargement or cyst of unknown etiology 10)Breast-feeding or lactation 11)Known Human Immunodeficiency Virus (HIV)-positive status, or a history of or current active infection with Hepatitis B or C. 12)History of allergy or hypersensitivity to progesterone preparations and/or their excipients, or any contraindication to receive progesterone preparations 13)History of or suspected alcohol or substance abuse within 5 years prior to the date of informed consent 14)Active thrombophlebitis, thromboembolic disorder or cerebral stroke, or a history of such conditions. 15)Judged as ineligible in the opinion of the site investigator or investigator.
Target sample size	180

Research contact person
Name of lead principal investigator	1st name Yukiko Middle name Last name Katagiri
Organization	Toho University
Division name	Reproduction Center (Genecology)
Zip code	1438541
Address	6-11-1 Omori-Nishi,Ota-ku,Tokyo
TEL	03-3762-4151
Email	yukikonk@med.toho-u.ac

Public contact
Name of contact person	1st name Research Secretariat Middle name Last name J-FOCAL study
Organization	Clinical Research Support Center Kyushu (CReS Kyushu)
Division name	J-FOCAL study Research Secretariat
Zip code	8128582
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-631-2920
Homepage URL
Email	j-focal@cres-kyushu.or.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Merck Biopharma Co.,Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Reserch Network Fukuoka Certified Review
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka , Fukuoka
Tel	092-643-7171
Email	mail@crnfukuoka.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	東邦大学医療センター大森病院（東京都）、医療法人財団順和会 山王病院（東京都）、慶應義塾大学病院（東京都）、滋賀医科大学医学部附属病院（滋賀県）、キネマARTクリニック（東京都）、杉山産婦人科 新宿（東京都）、日本医科大学付属病院（東京都）、東邦大学医療センター佐倉病院（千葉県）

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 02 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	Completed
Date of protocol fixation	2018 Year 02 Month 01 Day
Date of IRB	2018 Year 03 Month 19 Day
Anticipated trial start date	2018 Year 03 Month 19 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study design:Prospective study [single arm/non-randomized controlled trial/without control]

Management information
Registered date	2018 Year 02 Month 02 Day
Last modified on	2022 Year 02 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035530