Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism
Status: | Not yet recruiting |
---|---|
Conditions: | Endocrine |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/2/2016 |
Start Date: | September 2015 |
End Date: | October 2016 |
Contact: | Saturnino Luján, MD, PhD |
Email: | satlujan@gmail.com |
Phone: | 3129969330 |
A Randomized, Double-blind, Placebo-controlled Trial of Clomiphene Citrate of Clomiphene Citrate in Hypoandrogenism and Azoospermia
Hypothesis: Prescribed clomiphene citrate to azoospermic patients with hypoandrogenism could
improve the sperm retrieval in either fresh sperm or after surgical sperm extraction.
improve the sperm retrieval in either fresh sperm or after surgical sperm extraction.
Hypogonadism (low testosterone level) is frequently observed in men presenting with non
obstructive azoospermia. Controversy exists regarding the efficacy of preoperative hormonal
manipulation in patients with hypogonadism. However, it is possible that hormonal therapy
increases intra-testicular testosterone levels, and with a rise in serum testosterone, sperm
production and surgical success with microTESE improve.
obstructive azoospermia. Controversy exists regarding the efficacy of preoperative hormonal
manipulation in patients with hypogonadism. However, it is possible that hormonal therapy
increases intra-testicular testosterone levels, and with a rise in serum testosterone, sperm
production and surgical success with microTESE improve.
Inclusion Criteria:
- Patients over 18 years old.
- Man seeking fertility treatment.
- Azoospermia confirmed in at least 2 semen analyses with centrifugation.
- Testosterone <300 ng/dL and Bioavailable Testosterone<156 ng/dL.
Exclusion Criteria:
- Presence of genetic disorders: Y chromosome deletions or abnormal karyotypes.
- Luteinizing hormone (LH) >25 IU/mL.
- Estradiol > 40 ng/dL.
- Hypogonadotropic hypogonadism (LH <2 IU/mL and Follicle Stimulating Hormone (FSH) <1
IU/mL).
- Obstructive azoospermia (FSH <7.6 IU/mL plus testicle longitudinally axis >4.6 cm or
bilateral absence of vas deferens or surgical history of vasectomy).
- Clinical varicocele (palpable or visible in physical exam)
- Previous history of cryptorchidism.
- Use of chemotherapy, testosterone, or anti-androgen in the last two years. Partner
>40 years or female factor infertility associated.
- Contraindications to clomiphene use: depression, heart and liver impairment,
uncontrolled thyroid/adrenal dysfunction, organic intracranial lesions.
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