Hypogonadism Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Trial of Clomiphene Citrate of Clomiphene Citrate in Hypoandrogenism and Azoospermia
NCT number | NCT02137265 |
Other study ID # | 2014-0343 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | October 2020 |
Verified date | October 2020 |
Source | University of Illinois at Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hypothesis: Prescribed clomiphene citrate to azoospermic patients with hypoandrogenism could improve the sperm retrieval in either fresh sperm or after surgical sperm extraction.
Status | Withdrawn |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. |
Country | Name | City | State |
---|---|---|---|
Spain | University of Valencia | Valencia | Province Of Valencia |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago |
Spain,
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
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 |
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