UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Standard dose of effervescent progesterone vaginal tablet for luteal phase support in frozen embryo transfer cycle
Title of the study (Brief title)	SHIFT study
Region	Japan

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

Objectives
Narrative objectives1	To demonstrate the efficacy and safety of luteal support by Lutinus (Endometrin) vaginal tablet on ongoing pregnancy rate in Japanese patients undergoing frozen embryo transfer in real clinical settings.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	ongoing pregnancy rate (six weeks after administration of the drug)
Key secondary outcomes	1) hCG positive rate 2) clinical pregnancy rate 3) safety information 4) withdrawal rate 5) relationship between ongoing pregnancy rate and age or serum progesterone level

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Female
Key inclusion criteria	1) Patients who have given written informed consent to participate in this study 2) Patients who underwent IVF-ICSI to obtain autologous frozen embryo 3) Patients who will undergo the frozen embryo transfer in artificial cycles.
Key exclusion criteria	Patients who had a history of oversensitivity, abnormal uterine bleeding of undetermined origin, missed abortion, ectopic pregnancy, severe hepatic disorder, breast cancer, genital cancer and porphyria, and are under breast-feeding.
Target sample size	400

Research contact person
Name of lead principal investigator	TOSHIHIRO FUJIWARA
Organization	Sanno Hospital
Division name	Center for Human Reproduction and Gynecologic Endoscopy
Address	8-10-16 Akasaka, Minato-ku, Tokyo 107-0052 JAPAN
TEL	03-3402-3151
Email	fujiwat@iuhw.ac.jp

Public contact
Name of contact person	TOSHIHIRO FUJIWARA
Organization	Sanno Hospital
Division name	Center for Human Reproduction and Gynecologic Endoscopy
Address	8-10-16 Akasaka, Minato-ku, Tokyo 107-0052 JAPAN
TEL	03-3402-3151
Homepage URL	http://www.sannoclc.or.jp/hospital/
Email	metsugi@iuhw.ac.jp

Sponsor
Institute	Sanno Hospital
Institute
Department

Funding Source
Organization	Ferring Pharmaceuticals
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	JAPAN

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

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	山王病院（東京都） 高木病院（福岡県） 福岡山王病院（福岡県） 国際医療福祉大学病院（栃木県） セントマザー産婦人科（福岡県） セントルカ産婦人科（大分県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 19 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 08 Month 07 Day
Anticipated trial start date	2015 Year 10 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	under subjects enrolling

Management information
Registered date	2016 Year 04 Month 19 Day
Last modified on	2016 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021713