Non Obstructive AzoospermiaNCT02137265
Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism
A study testing Clomiphene in people with Non Obstructive Azoospermia and Hypogonadism, run by University of Illinois Chicago at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Non Obstructive Azoospermia, Hypogonadism
- What is being tested?
- Clomiphene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Non Obstructive Azoospermia, Hypogonadism
- Being tested
- Clomiphene, Placebo
- Keywords
- Azoospermia, Hypogonadism, Clomiphene
- Medical subject headings
- Hypogonadism, Azoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClomipheneDrug
Also called Clomid, Serophene
Clomiphene citrate 50 mg orally daily
PlaceboDrug
Also called control
One pill every other day
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene citrate | Active comparator | Clomiphene citrate 50 mg daily during 4-6 months Receives: Drug: Clomiphene |
| Placebo | Placebo comparator | Placebo (1 pill daily) during 4-6 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE)
Measured: After four months of clomiphene treatment
Epigenetic modifications
Measured: After four months of clomiphene treatment
Secondary outcomes (1)
Testosterone levels and Bioavailable Testosterone levels
Measured: After two weeks and four months with clomiphene treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startSep 2015
- Primary completionOct 2020
- Study completionOct 2020 (estimated)
Why it stopped: No funding obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non Obstructive AzoospermiaStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Craig Niederberger, University of Illinois Chicago
- Investigators
- Saturnino Luján, MD, PhD, Study chair, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137265
- Sponsor's protocol ID
- 2014-0343
- Status last verified
- Oct 2020
- First submitted
- 9 May 2014
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16291975Hussein 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.
PubMed 22958644
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial of Clomiphene Citrate of Clomiphene Citrate in Hypoandrogenism and Azoospermia
- ClinicalTrials.gov ID
- NCT02137265
- Acronym / sponsor ID
- 2014-0343
- Conditions
- Non Obstructive Azoospermia, Hypogonadism
- Keywords
- Azoospermia, Hypogonadism, Clomiphene
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (estimated)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clomiphene citrate | Active comparator | Drug: ClomipheneClomiphene citrate 50 mg daily during 4-6 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (1 pill daily) during 4-6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClomipheneAlso: Clomid, SeropheneClomiphene citrate 50 mg orally daily | Drug | Clomiphene citrate |
| PlaceboAlso: controlOne pill every other day | Drug | Placebo |
Primary outcome
Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE)
Time frame: After four months of clomiphene treatment
Epigenetic modifications
Time frame: After four months of clomiphene treatment
1 secondary outcome
Testosterone levels and Bioavailable Testosterone levels
Time frame: After two weeks and four months with clomiphene treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Results publication: PubMed 16291975Hussein 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.
- Results publication: PubMed 22958644Hussein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saturnino Luján, MD, PhD study chair
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clomiphene in people with Non Obstructive Azoospermia and Hypogonadism, run by University of Illinois Chicago at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE) (time frame: After four months of clomiphene treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02137265, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.