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Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we compared the different efficacy and safety of pulsatile GnRH pump therapy with combination gonadotropin therapy on fertility and sexual development in male patients with IHH.
Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we compared the different efficacy and safety of pulsatile GnRH pump therapy with combination gonadotropin therapy on fertility and sexual development in male patients with IHH.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsatile Gonadotropin Releasing Hormone | Experimental | 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. |
|
| combination gonadotropin therapy | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsatile Gonadotropin Releasing Hormone | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| pregnancy in the female partner | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| first appearance of sperm (month after treatment) | 18 months | |
| first time with sperm density>1*10^6/ml(month after treatment) | 18 months | |
| first time with sperm density>15*10^6/ml(month after treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| testicular volume | 18 months | |
| prostatic volume | 18 months | |
| Tanner stage for pubic hair |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guang Ning, MD, PHD | Shanghai Jiao Tong University School of Medicine | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31681165 | Derived | 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. |
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| Human chorionic gonadotropin |
| Drug |
Human chorionic gonadotropin (hCG) |
|
| Urinary Follicle-Stimulating Hormone | Drug | Urinary Follicle-Stimulating Hormone (uFSH) |
|
| 18 months |
| 18 months |
| Tanner stage for genital | 18 months |
| serum hormone levels | especially serum testosterone, LH, and FSH levels | 18 months |
| sperm concentration per ejaculate | 18 months |
| adverse events | 18 months |
| ID | Term |
|---|---|
| C562785 | Idiopathic Hypogonadotropic Hypogonadism |
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| ID | Term |
|---|---|
| D006063 | Chorionic Gonadotropin |
| D050477 | Urofollitropin |
| ID | Term |
|---|---|
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |
| D008596 | Menotropins |
| D006065 | Gonadotropins, Pituitary |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
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