UMIN-CTR Clinical Trial

Basic information
Public title	A study on infantile gonadotropin treatment for male hypogonadotropic hypogonadism
Acronym	Infantile gonadotropin treatment study (IGTS)
Scientific Title	A multicenter study on infantile gonadotropin treatment for male hypogonadotropic hypogonadism (MHH)
Scientific Title:Acronym	Infantile Gn treatment study for MHH
Region	Japan

Condition
Condition	Male hypogonadotropic hypogonadism
Classification by specialty	Endocrinology and Metabolism Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the safety and efficacy of infantile gonadotropin treatment for male hypogonadotropic hypogonadism
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in penile length at the end of observation period, compared with pretreatment period
Key secondary outcomes	Efficacy Change in testis size at the end of observation period, compared with pretreatment period Change in testicular position at the end of observation period, compared with pretreatment period Changes in serum anti-Mullerian hormone, testosterone, and FSH before, during, and after treatment Safety Changes in bone age before and after treatment Presence of adverse events

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1. Human chorionic gonadotropin (hCG) preparation (Brand name: HCG for intramuscular injection) 500 IU once a week, intramuscular injection into the thigh 2. Recombinant human FSH (rFSH) Subcutaneous injection of 25 IU 3 times a week Continue for 12 weeks
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	30 weeks-old >
Gender	Male
Key inclusion criteria	1. Prospective intervention trial group 1) Having one of the following three symptoms; Small penis (extended penis length less than 25 mm) Small testis (testis volume less than 1 mL) Undescended testes examined at least once 2) Insufficiency of gonadotropin secretion confirmed by one of the following methods A) LH value less than 0.5 (IU/L) at less than 210 days after birth B) LH peak value less than 2 mIU/ml and LH/FSH ratio of less than 1.0 in LHRH test conducted less than 210 days after birth. C)Identified hypoplasia of the olfactory bulb and olfactory sulcus on MRI 2. Historical control group Patients seen at the facility between April 2000 and March 2017 with a follow-up more than 3 years The above 1) and 2) have been confirmed at the time of first medical examination or before treatment with testosterone etc.
Key exclusion criteria	1. Prospective intervention trial group 1) Patients who have been treated with gonadotropin preparations or any of the following prohibited drugs 2) Patients with congenital malformations such as hydro-encephalopathy affecting life prognosis and brain tumors. 2. Historical control group Patients satisfying 1) described above <Prohibited drugs> 1. Testosterone preparation (testosterone enanthate, DHT cream) (However, adding testosterone preparations to the small penis after intervention treatment is an additional treatment and is not prohibited.) 2. hMG formulation 3. Anabolic hormone agents 4. Estrogen preparation 5. Aromatase inhibitor 6. Spironolactone 7. GnRH agonist formulation
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yukihiro Middle name Last name Hasegawa
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Division of Endocrinology and Metabolism
Zip code	1838561
Address	2-8-29 Musashidai, Futyu, Tokyo,Japan 183-8561
TEL	81-42-300-5111
Email	yhaset@gmail.com

Public contact
Name of contact person	1st name Yukihiro Middle name Last name Hasegawa
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Division of Endocrinology and Metabolism
Zip code	1838561
Address	2-8-29 Musashidai, Futyu, Tokyo,Japan 183-8561
TEL	81-42-300-5111
Homepage URL
Email	yhaset@gmail.com

Sponsor
Institute	Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kumamoto University Kyushu University Kurume University Oita University Niigata University Hokkaido University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Metropolitan Children's Medical Center
Address	2-8-29 Musashidai, Futyu, Tokyo,Japan 183-8561
Tel	042-300-5111 (81-423-00-5111)
Email	yhaset@gmail.com

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	東京都立小児総合医療センター/Tokyo Metropolitan Children's Medical Center

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 05 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	Open public recruiting
Date of protocol fixation	2020 Year 01 Month 29 Day
Date of IRB	2020 Year 01 Month 29 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2025 Year 09 Month 01 Day
Date of closure to data entry	2026 Year 09 Month 01 Day
Date trial data considered complete	2027 Year 03 Month 01 Day
Date analysis concluded	2027 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date	2022 Year 03 Month 04 Day
Last modified on	2022 Year 03 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053711