Clinical trial NCT02137265: Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism
Official title: A Randomized, Double-blind, Placebo-controlled Trial of Clomiphene Citrate of Clomiphene Citrate in Hypoandrogenism and Azoospermia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Non Obstructive Azoospermia
Hypogonadism
Keywords: Azoospermia
Hypogonadism
Clomiphene
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Prescribed clomiphene citrate to azoospermic patients with hypoandrogenism could improve the sperm retrieval in either fresh sperm or after surgical sperm extraction.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE)
timeFrame: After four months of clomiphene treatment
measure: Epigenetic modifications
timeFrame: After four months of clomiphene treatment
Secondary outcomes:
measure: Testosterone levels and Bioavailable Testosterone levels
timeFrame: After two weeks and four months with clomiphene treatment
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
state: Province Of Valencia
Study officials:
affiliation: University of Valencia
name: Saturnino Luján, MD, PhD
role: STUDY_CHAIR
References:
citation: Hussein A, Ozgok Y, Ross L, Niederberger C. Clomiphene administration for cases of nonobstructive azoospermia: a multicenter study. J Androl. 2005 Nov-Dec;26(6):787-91; discussion 792-3. doi: 10.2164/jandrol.04180.
citation: Hussein A, Ozgok Y, Ross L, Rao P, Niederberger C. Optimization of spermatogenesis-regulating hormones in patients with non-obstructive azoospermia and its impact on sperm retrieval: a multicentre study. BJU Int. 2013 Mar;111(3 Pt B):E110-4. doi: 10.1111/j.1464-410X.2012.11485.x. Epub 2012 Sep 7.