UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study to Determine the Optimal Starting Dose of FSH in a Low- Dose-Stepup Regimen
Title of the study (Brief title)	Study to Determine the Optimal Starting Dose of FSH in a Low- Dose-Stepup Regimen
Region	Japan

Condition
Condition	WHO group II ovarian failure (first-grade amenorrhea, oligomenorrhea, or anovulatory cycle), luteal phase insufficiency, or unexplained infertility
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is designed to evaluate the efficacy and safety of a low-dose-stepup regimen of recombinant human FSH (Gonalef Pen) with BMI-based starting dose levels.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Proportion of subjects whose dominant follicles grow to a mean diameter of 18 mm within 10 days after starting FSH administration and the cumulative FSH dose needed to reach this endpoint
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	At 50 IU if BMI is less than 20 kg/m2,Follicular growth will be monitored by transvaginal ultrasonography (US) on the 7th day of administration and every 2-4 days thereafter. In the absence of sufficient follicular growth, the FSH dose may be increased every 7 days in steps of 12.5 IU. A total of 4 dose escalations will be permitted. When the mean diameter of dominant follicle has reached 18 mm as confirmed by transvaginal US, a single dose of 5,000 IU of hCG will be administered to induce ovulation.
Interventions/Control_2	At 62.5 IU if BMI is not less than 20 kg/m2,Follicular growth will be monitored by transvaginal ultrasonography (US) on the 7th day of administration and every 2-4 days thereafter. In the absence of sufficient follicular growth, the FSH dose may be increased every 7 days in steps of 12.5 IU. A total of 4 dose escalations will be permitted. When the mean diameter of dominant follicle has reached 18 mm as confirmed by transvaginal US, a single dose of 5,000 IU of hCG will be administered to induce ovulation.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1) WHO group II ovarian failure (first-grade amenorrhea, oligomenorrhea, or anovulatory cycle), luteal phase insufficiency, or unexplained infertility 2) Written informed consent to the study given before enrollment
Key exclusion criteria	1) WHO group I ovarian failure (second-grade [central] amenorrhea) 2) WHO group III ovarian failure (ovarian amenorrhea) 3) Hyperprolactinemia
Target sample size	50

Research contact person
Name of lead principal investigator	MInoru Irahara
Organization	Tokushima University Hospital
Division name	Head of the Department of Obstetrics and Gynecology
Address	2-50-1, Kuramoto, Tokushima 770-8503, Japan
TEL	0886313111
Email	irahara@tokushima-u.ac.jp

Public contact
Name of contact person	Toshiya Matsuzaki
Organization	Tokushima University Hospital
Division name	Sub-Head of the Department of Obstetrics and Gynecology
Address	2-50-1, Kuramoto, Tokushima 770-8503, Japan
TEL	0886313111
Homepage URL
Email	matsuzaki.toshiya@tokushima-u.ac.jp

Sponsor
Institute	Department of Obstetrics and Gynecology,Tokushima University Hospital
Institute
Department

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

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 29 Day
Anticipated trial start date	2014 Year 12 Month 01 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

Management information
Registered date	2014 Year 11 Month 12 Day
Last modified on	2018 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018194