Non-obstructive AzoospermiaNCT04308486
Anti-mullerian Hormone,Testesterone,Esrtadiol,Testesterone/Esrtadiol Ratio as Predictive Values for TESA and TESE Outcome in Non Obstructive Azoospermia
An observational study of Non-obstructive Azoospermia, run by Assiut University.
Trial summary
*Evaluate the predictive value of AMH, Testosterone,Estradiol,Testosterone Estradiol ratio for TESA and TESE outcome in non obstructive azoospermic patients. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Non-obstructive Azoospermia
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Feb 2022
- Phase
- Observational
- 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 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Study population: 50 men within 20 to 50 years with non obstructive azoospermia undergoing TESA or TESE
Who may be able to join
- a clinical diagnosis of NOA associated with primary couple's infertility;
- age from 20 to 50 years old
- freedom from any known systemic diseases affecting the previous hormonal levels such as liver cirrhosis .
- hormonal therapy for at least two weeks prior to the surgery
Who cannot join
- obstructive azoospermia
- congenital bilateral absent vas
Trial locations and contacts
No sites are listed yet.
About this study
*Evaluate the predictive value of AMH, Testosterone,Estradiol,Testosterone Estradiol ratio for TESA and TESE outcome in non obstructive azoospermic patients.
Read the detailed description
- The relevance of male infertility has progressively grown , with significant medical, psychological, and socio-economic implications. .. With no sperm found at multiple semen analyses, non-obstructive azoospermia (NOA) is the most severe form of infertility.
- The introduction to clinical practice of assisted reproduction techniques such as intra-cytoplasmic sperm injection (ICSI) made fatherhood possible for men with (NOA). The extraction of sperm from the testis through testicular sperm aspiration (TESA), testicular sperm extraction (TESE) or open biopsy can result in a favorable reproductive outcome. Nevertheless, all these procedures are invasive in nature with variable possibility of successful sperm extraction. As a consequence, a non-invasive test that could predict the presence of sperm in men with NOA would be of profound clinical importance
- However, the lack of useful predictive biomarkers suggestive for successful sperm retrieval at microTESE and TESA in NOA men still represents a relevant gap with a very negative return for the patient. Indeed, no significant association has been found between microTESEand TESA sperm retrieval outcomes and preoperative testicular volume, baseline follicular stimulating hormone (FSH) levels, basal level of Testosterone (T) or increased T level following treatments with aromatase inhibitors, clomiphene citrate or human chorionic gonadotropin.
- Therefore, it has been amust to identify novel and user-friendly prognostic factors reliably predicting surgical outcomes in NOA men in the real-life setting. Among other variables, some hormons can be subjected to studies for this purpose such as levels of testis-derived hormones (which might be representative of the primary testicular failure) as the Anti-Müllerian Hormone (AMH),( which is suggestive for a Sertoli cells' immature phenotype),and testosterone of biological relevance...
- An investigation from the early 1970s demonstrated that the human testis does indeed secrete estradiol within the spermatic vein, at amean concentration that is 50 times greater than that inthe peripheral plasma . These findings led to the hypothesis that local estrogen levels might be associated with the current stateof spermatogenesis, or the total number of spermatogenic cells in the testis.
- Conditions
- Non-obstructive Azoospermia
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the predictive value of Anti-mullerian hormone,Testosterone,Estradiol,Testosterone/Estradiol ratio for TESA and TESE outcome in non obstructive azoospermia
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Ahmed Ashraf Fakhr Eldeen Hamoda, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308486
- Sponsor's protocol ID
- prediction of TESA and TESE
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alfano M, Ventimiglia E, Locatelli I, Capogrosso P, Cazzaniga W, Pederzoli F, Frego N, Matloob R, Sacca A, Pagliardini L, Vigano P, Zerbi P, Nebuloni M, Pontillo M, Montorsi F, Salonia A. Anti-Mullerian Hormone-to-Testosterone Ratio is Predictive of Positive Sperm Retrieval in Men with Idiopathic Non-Obstructive Azoospermia. Sci Rep. 2017 Dec 15;7(1):17638. doi: 10.1038/s41598-017-17420-z.
PubMed 29247212Matuszczak E, Hermanowicz A, Komarowska M, Debek W. Serum AMH in Physiology and Pathology of Male Gonads. Int J Endocrinol. 2013;2013:128907. doi: 10.1155/2013/128907. Epub 2013 Oct 24.
PubMed 24282408Toulis KA, Iliadou PK, Venetis CA, Tsametis C, Tarlatzis BC, Papadimas I, Goulis DG. Inhibin B and anti-Mullerian hormone as markers of persistent spermatogenesis in men with non-obstructive azoospermia: a meta-analysis of diagnostic accuracy studies. Hum Reprod Update. 2010 Nov-Dec;16(6):713-24. doi: 10.1093/humupd/dmq024. Epub 2010 Jul 1.
PubMed 20601364
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-mullerian Hormone,Testesterone,Esrtadiol,Testesterone/Esrtadiol Ratio as Predictive Values for TESA and TESE Outcome in Non Obstructive Azoospermia
- ClinicalTrials.gov ID
- NCT04308486
- Acronym / sponsor ID
- prediction of TESA and TESE
- Conditions
- Non-obstructive Azoospermia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 16 Mar 2020 (actual)
- 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.
*Evaluate the predictive value of AMH, Testosterone,Estradiol,Testosterone Estradiol ratio for TESA and TESE outcome in non obstructive azoospermic patients.
Detailed description
- The relevance of male infertility has progressively grown , with significant medical, psychological, and socio-economic implications. .. With no sperm found at multiple semen analyses, non-obstructive azoospermia (NOA) is the most severe form of infertility.
- The introduction to clinical practice of assisted reproduction techniques such as intra-cytoplasmic sperm injection (ICSI) made fatherhood possible for men with (NOA). The extraction of sperm from the testis through testicular sperm aspiration (TESA), testicular sperm extraction (TESE) or open biopsy can result in a favorable reproductive outcome. Nevertheless, all these procedures are invasive in nature with variable possibility of successful sperm extraction. As a consequence, a non-invasive test that could predict the presence of sperm in men with NOA would be of profound clinical importance
- However, the lack of useful predictive biomarkers suggestive for successful sperm retrieval at microTESE and TESA in NOA men still represents a relevant gap with a very negative return for the patient. Indeed, no significant association has been found between microTESEand TESA sperm retrieval outcomes and preoperative testicular volume, baseline follicular stimulating hormone (FSH) levels, basal level of Testosterone (T) or increased T level following treatments with aromatase inhibitors, clomiphene citrate or human chorionic gonadotropin.
- Therefore, it has been amust to identify novel and user-friendly prognostic factors reliably predicting surgical outcomes in NOA men in the real-life setting. Among other variables, some hormons can be subjected to studies for this purpose such as levels of testis-derived hormones (which might be representative of the primary testicular failure) as the Anti-Müllerian Hormone (AMH),( which is suggestive for a Sertoli cells' immature phenotype),and testosterone of biological relevance...
- An investigation from the early 1970s demonstrated that the human testis does indeed secrete estradiol within the spermatic vein, at amean concentration that is 50 times greater than that inthe peripheral plasma . These findings led to the hypothesis that local estrogen levels might be associated with the current stateof spermatogenesis, or the total number of spermatogenic cells in the testis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 50 men within 20 to 50 years with non obstructive azoospermia undergoing TESA or TESE
Key inclusion criteria (4 listed)
- a clinical diagnosis of NOA associated with primary couple's infertility;
- age from 20 to 50 years old
- freedom from any known systemic diseases affecting the previous hormonal levels such as liver cirrhosis .
- hormonal therapy for at least two weeks prior to the surgery
Key exclusion criteria (2 listed)
- obstructive azoospermia
- congenital bilateral absent vas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the predictive value of Anti-mullerian hormone,Testosterone,Estradiol,Testosterone/Estradiol ratio for TESA and TESE outcome in non obstructive azoospermia
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Background: PubMed 29247212Alfano M, Ventimiglia E, Locatelli I, Capogrosso P, Cazzaniga W, Pederzoli F, Frego N, Matloob R, Sacca A, Pagliardini L, Vigano P, Zerbi P, Nebuloni M, Pontillo M, Montorsi F, Salonia A. Anti-Mullerian Hormone-to-Testosterone Ratio is Predictive of Positive Sperm Retrieval in Men with Idiopathic Non-Obstructive Azoospermia. Sci Rep. 2017 Dec 15;7(1):17638. doi: 10.1038/s41598-017-17420-z.
- Background: PubMed 24282408Matuszczak E, Hermanowicz A, Komarowska M, Debek W. Serum AMH in Physiology and Pathology of Male Gonads. Int J Endocrinol. 2013;2013:128907. doi: 10.1155/2013/128907. Epub 2013 Oct 24.
- Background: PubMed 20601364Toulis KA, Iliadou PK, Venetis CA, Tsametis C, Tarlatzis BC, Papadimas I, Goulis DG. Inhibin B and anti-Mullerian hormone as markers of persistent spermatogenesis in men with non-obstructive azoospermia: a meta-analysis of diagnostic accuracy studies. Hum Reprod Update. 2010 Nov-Dec;16(6):713-24. doi: 10.1093/humupd/dmq024. Epub 2010 Jul 1.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-obstructive Azoospermia, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reham Ahmed Ashraf, master student (01093001232, salmasassojoe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the predictive value of Anti-mullerian hormone,Testosterone,Estradiol,Testosterone/Estradiol ratio for TESA and TESE outcome in non obstructive azoospermia (time frame: baseline). 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 NCT04308486, which also lists 3 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 16 Mar 2020.