Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism

Hypogonadism Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Trial of Clomiphene Citrate of Clomiphene Citrate in Hypoandrogenism and Azoospermia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02137265
• Other study ID #: 2014-0343
• Status: Withdrawn
• Phase: N/A
• Start date: September 2015
• Est. completion date: October 2020

Study information

• Verified date: October 2020
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Azoospermia
• Hypogonadism
• Non Obstructive Azoospermia

Intervention

Drug:
• Clomiphene
Clomiphene citrate 50 mg orally daily
• Placebo
One pill every other day

Locations

Country	Name	City	State
Spain	University of Valencia	Valencia	Province Of Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE)		After four months of clomiphene treatment
Primary	Epigenetic modifications		After four months of clomiphene treatment
Secondary	Testosterone levels and Bioavailable Testosterone levels		After two weeks and four months with clomiphene treatment