Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
NCT ID: NCT02310074
Last Updated: 2015-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
76 participants
INTERVENTIONAL
2010-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Studying the Effects of 7 Days of Gonadotropin Releasing Hormone (GnRH) Treatment in Men With Hypogonadism
NCT00493961
Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome
NCT02705014
Examination of Idiopathic Hypogonadotropic Hypogonadism (IHH)and Kallmann Syndrome (KS)
NCT00392756
Efficacy of Prolonged GnRH Test in Male Adolescents With Postoperative HH
NCT05184374
To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection
NCT06561594
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The primary endpoint was the achievement of pregnancy in female partner. Secondary endpoints were time to actual attainment of various sperm thresholds: sperm concentration\>0\*10\^6/ml , \>1.0 \*10\^6/ml and \>15 \*10\^6/ml, respectively.
The clinical and laboratory characteristics including testicular and prostatic volume, Tanner stage for pubic hair and genital, serum hormone levels \[especially serum testosterone,luteinizing hormone (LH) , and Follicle-Stimulating Hormone (FSH) levels\], sperm concentration per ejaculate, and adverse events at baseline and at the end of treatment were also evaluated.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pulsatile Gonadotropin Releasing Hormone
Pulsatile Gonadotropin Releasing Hormone: subjects in the GnRH group initiated a regimen of pulsatile GnRH administered subcutaneously via a portable infusion pump for 18 months.
Pulsatile Gonadotropin Releasing Hormone
combination gonadotropin therapy
combined human chorionic gonadotropin (hCG)/urinary Follicle-Stimulating Hormone (uFSH) therapy:HCG treatment was maintained alone for 6 months and then uFSH was added for the next 12 months
Human chorionic gonadotropin
Human chorionic gonadotropin (hCG)
Urinary Follicle-Stimulating Hormone
Urinary Follicle-Stimulating Hormone (uFSH)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pulsatile Gonadotropin Releasing Hormone
Human chorionic gonadotropin
Human chorionic gonadotropin (hCG)
Urinary Follicle-Stimulating Hormone
Urinary Follicle-Stimulating Hormone (uFSH)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Diagnosed as idiopathic hypogonadotropic hypogonadism with clinical signs or symptoms of hypogonadism
3. Hypogonadal serum testosterone levels (\<166ng/dl) in the presence of low or normal gonadotropins
4. Normal levels of other anterior pituitary hormones
5. Normal MRI scans of the hypothalamo-pituitary region
6. Had discontinued any prior treatment (testosterone or gonadotropin therapy) for at least three months before enrollment
Exclusion Criteria
2. Congenital hypopituitarism
3. Any medical or surgical conditions possibly affecting the experiment result
4. Any clinically significant allergic diseases or allergic to the study drugs
5. Recently drug or alcohol abuse(\>35unit/week,1unit=8 g alcohol@1 standard drink@250ml beer@140ml wine@25ml strong alcohol drink like whiskey.)
16 Years
35 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Guang Ning
the vice-president of Shanghai Jiao Tong University Affiliated Ruijin Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Guang Ning, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong University School of Medicine
References
Explore related publications, articles, or registry entries linked to this study.
Yang YY, Zheng SC, Wang WC, Yang ZW, Shan C, Zhang YW, Qi Y, Chen YH, Gu WQ, Wang WQ, Zhao HY, Liu JM, Sun SY. Osteocalcin Levels in Male Idiopathic Hypogonadotropic Hypogonadism: Relationship With the Testosterone Secretion and Metabolic Profiles. Front Endocrinol (Lausanne). 2019 Oct 11;10:687. doi: 10.3389/fendo.2019.00687. eCollection 2019.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ruijin-GnRH pump-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.