UMIN-CTR Clinical Trial

Public title

Study to Determine the Optimal Starting Dose of FSH in a Low- Dose-Stepup Regimen

Acronym

Study to Determine the Optimal Starting Dose of FSH in a Low- Dose-Stepup Regimen

Scientific Title

Study to Determine the Optimal Starting Dose of FSH in a Low- Dose-Stepup Regimen

Scientific Title:Acronym

Study to Determine the Optimal Starting Dose of FSH in a Low- Dose-Stepup Regimen

Region

Japan

Condition

WHO group II ovarian failure (first-grade amenorrhea, oligomenorrhea, or anovulatory cycle), luteal phase insufficiency, or unexplained infertility

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	MInoru Irahara

Organization

Tokushima University Hospital

Division name

Head of the Department of Obstetrics and Gynecology

Zip code

Address

2-50-1, Kuramoto, Tokushima 770-8503, Japan

TEL

0886313111

Email

irahara@tokushima-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Toshiya Matsuzaki

Organization

Tokushima University Hospital

Division name

Sub-Head of the Department of Obstetrics and Gynecology

Zip code

Address

2-50-1, Kuramoto, Tokushima 770-8503, Japan

TEL

0886313111

Homepage URL

Email

matsuzaki.toshiya@tokushima-u.ac.jp

Institute

Department of Obstetrics and Gynecology,Tokushima University Hospital

Institute

Department

Personal name

Organization

Merck Serono Co.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

11

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

09

Month

29

Day

Date of IRB

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

Other related information

Registered date

2014

Year

11

Month

12

Day

Last modified on

2018

Year

12

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018194