Clinical trial: Efficacy and Safety of Long Term Use of hCG or hCG Plus hMG in Males With Isolated Hypogonadotropic Hypogonadism (IHH) (NCT03687606)

Eligibility criteria:
Inclusion Criteria:

          1. Age ≥ 18, ≤ 45 years old;

          2. Adolescent dysplasia or loss of puberty: Genital Tanner score ﹤ 5, pubic hair Tanner
             score ﹤ 5;

          3. Serum FSH and LH levels are low or in normal low value, testosterone was lower than
             normal range (1.75ng / ml, the lower limit of the normal blood testosterone reference
             range of Tongji Hospital affiliated to Tongji Medical College, Huazhong University of
             Science and Technology);

          4. With or without olfactory loss/reduction;

          5. Other pituitary hormone levels are normal;

          6. Head MRI examination is normal;

          7. Fertility is desired currently or will be desired in the future;

          8. Understand and sign the informed consent form.

        Exclusion Criteria:

          1. Primary hypogonadism;

          2. Acquired hypogonadotrophic hypogonadism;

          3. A history of treatment with pulsed GnRH, hCG and FSH related hormones;

          4. Receive testosterone replacement therapy for more than 6 months;

          5. History of cryptorchidism or cryptorchidism;

          6. The sperm density before treatment ≥1×10^6/ml;

          7. Moderate or severe liver and kidney dysfunction (ALT>120IU/L, AST>80IU/L,
             CR>115μmol/L);

          8. The karyotype is 45,X or 47,XXY and 48, XXXY and other abnormal karyotypes;

          9. True hermaphroditism and pseudohermaphroditism;

         10. Sex hormone abnormalities caused by adrenal lesions;

         11. Hypogonadism secondary to other systemic diseases;

         12. Abnormal secretion of hormones caused by brain lesions (such as pituitary tumors);

         13. There are other hormone abnormalities in the pituitary;

         14. There are contraindications for the treatment with hCG or hMG.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 19-year-old male came to clinic with some sexual concern.  He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates.  On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH.

Patient description (patient's own words): I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels.

Does the patient match the trial criteria? Contradiction