UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031115 |
|---|---|
| Receipt number | R000035530 |
| Scientific Title | Japanese study of the outcome of hormonally controlled FET cycles using OneCrinone as luteal support |
| Date of disclosure of the study information | 2018/02/02 |
| Last modified on | 2022/02/07 16:01:28 |
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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
| Obstetrics 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
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
j-focal@cres-kyushu.or.jp
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035530
