Azoospermia Anogenital Distance AMHKSNCT06396117
Relationship Between Anogenital Distance, Serum AMH, and mTESE in Klinefelter Syndrome
An observational study of Azoospermia Anogenital Distance AMH, run by Cairo University at 1 site in Egypt.
Trial summary
Azoospermia, the absence of sperm in the ejaculate, affects approximately 1% of males and 15% of infertile men. Non-obstructive azoospermia (NOA) accounts for 60% of azoospermic patients, who rely solely on testicular sperm extraction (TESE) surgery for sperm harvesting. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men only
- Conditions the study is for
- Azoospermia Anogenital Distance AMH
- What is being tested?
- mTESE (microscopic testicular sperm extraction)
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Feb 2024
- 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 40 years
- Men only
- No healthy volunteers
- Adult
Study population: Male patients with non-obstructive azoospermia of any age group suffering from infertility who did two successive semen analyses at least two weeks apart showing no sperms in ejaculate with normal or elevated gonadotrophic hormones and will undergo Testicular Sperm Extraction operation at Andrology Department, Kasr Al Ainy hospital Cairo University.
Who may be able to join
- All NOA patients underwent mTESE at the Andrology department, Kasr Al-Ainy hospitals
Who cannot join
- patients with
- Obstructive azoospermia
- Retrograde Ejaculation
- Men with hypogonadotropic hypogonadism
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr Alainy
Cairo, Please Select A Region, State Or Province., 11231
About this study
Official title: Relationship Between Anogenital Distance and Serum AMH and mTESE Associated With or Without Klinefelter Syndrome
Azoospermia, the absence of sperm in the ejaculate, affects approximately 1% of males and 15% of infertile men. Non-obstructive azoospermia (NOA) accounts for 60% of azoospermic patients, who rely solely on testicular sperm extraction (TESE) surgery for sperm harvesting. While conventional TESE (cTESE) and microdissection TESE (mTESE) are preferred methods, the lack of predictive biomarkers for successful sperm retrieval (SR) renders treatment unnecessary for many NOA males. However, research suggests that anti-Mullerian hormone (AMH) and anogenital distance (AGD) may serve as predictors of positive SR at mTESE in NOA males. AGD, a marker of fetal androgen disruption and adult outcomes, may also assess male reproductive potential by predicting normal genital growth and sperm creation. A cross-sectional study found a positive correlation between AGD and total sperm count, concentration, and motility in infertile men aged 25-38, providing valuable prognostic insights for azoospermic men.
Read the detailed description
Azoospermia, which is defined as the lack of spermatozoa in the ejaculate, is a condition that affects around one percent of males and fifteen percent of men who are infertile. Sixty percent of azoospermic patients are affected by non-obstructive azoospermia, often known as NOA.
To harvest sperm for assisted reproductive technology (ART), this subset of men has no other choice except to undergo testicular sperm extraction (TESE) surgery.
Conventional TESE (cTESE) and microdissection TESE (mTESE) are the most preferred procedures in terms of sperm retrieval (SR) rates and the decrease of damage caused by excision. Studies have revealed varying percentages of positive SR, ranging from thirty percent to sixty percent.
This treatment is not necessary for a significant number of NOA boys because there are no biomarkers or procedures that are clinically acceptable that can predict a positive SR score at mTESE.
According to earlier research, anti-mullerian hormone (AMH), which is a homodimeric glycoprotein belonging to the family of transforming growth factor-b, has the potential to predict either a positive or negative significant difference (SR) at mTESE in iNOA. Throughout the course of development, Sertoli cells (SCs) secrete Amyloid-beta (AMH) in order to regress the Mullerian ducts and ensure that male sex differentiation occurs. AMH levels drop significantly when the development of puberty in males and the maturation of SCs occurs. It has been suggested that this hormone, which is solely produced by spermatocytes in males, can be used as an indirect marker of spermatogenesis, maturation of spermatocytes, and immaturity of the prepubertal testes.
A noninvasive method known as anogenital distance has recently been applied for the purpose of predicting and diagnosing disorders. There are two different measurements of the anogenital distance (AGD) for both men and women. AGD is a marker that indicates fetal androgen dysregulation as well as negative effects in adulthood. AGD is a unique method that can be used to evaluate the reproductive potential of males because it has the capacity to predict normal male genital growth and the production of sperm. It may also assist medical professionals in providing prognostic information to men who are azoospermic.
AGD AS was found to have a positive correlation with total sperm count, concentration, and motility in a cross-sectional study where the participants were infertile men between the ages of 25 and 38.
- Conditions
- Azoospermia Anogenital Distance AMH
- Being tested
- mTESE (microscopic testicular sperm extraction)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mTESE (microscopic testicular sperm extraction)Other
Microdissection Testicular Sperm Extraction (mTESE) is a surgical procedure used to retrieve sperm from the testicles of men with non-obstructive azoospermia (NOA). It involves:
- Testicular biopsy: Removing a small sample of testicular tissue.
- Microscopic examination: Examining the tissue under a microscope to identify areas with sperm production.
- Sperm extraction: Dissecting out individual sperm cells from the testicular tissue.
This technique allows for:
- More accurate identification of sperm-containing areas
- Lower risk of damage to surrounding testicular tissue
- Potential for higher sperm retrieval rates compared to conventional method
| Study group | Role | What they receive |
|---|---|---|
| patients who have KS | Group one is patients with Klinefelter syndrome confirmed as 47, XXY on karyotyping undergoing mTESE for non-obstructive azoospermia Receives: Other: mTESE (microscopic testicular sperm extraction) | |
| Patient who does not have KS | Group two consists of patients with a normal karyotyping undergoing mTESE for non-obstructive azoospermia Receives: Other: mTESE (microscopic testicular sperm extraction) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation of AGD of males with azoospermia (with or without KS) to mTESE outcome
Higher AGD might be correlated to higher sperm retrieval
Measured: 1 months
Relation of AMH in males with azoospermia (with or without KS) to mTESE outcome
Higher AMH might be correlated to higher sperm retrieval
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Mar 2023
- Primary completion1 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Azoospermia Anogenital Distance AMHStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Wael Ragab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396117
- Sponsor's protocol ID
- AND AMH
- Acronym
- KS
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Anogenital Distance and Serum AMH and mTESE Associated With or Without Klinefelter Syndrome
- ClinicalTrials.gov ID
- NCT06396117
- Acronym / sponsor ID
- KS / AND AMH
- Conditions
- Azoospermia Anogenital Distance AMH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 2 May 2024 (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.
Azoospermia, the absence of sperm in the ejaculate, affects approximately 1% of males and 15% of infertile men. Non-obstructive azoospermia (NOA) accounts for 60% of azoospermic patients, who rely solely on testicular sperm extraction (TESE) surgery for sperm harvesting. While conventional TESE (cTESE) and microdissection TESE (mTESE) are preferred methods, the lack of predictive biomarkers for successful sperm retrieval (SR) renders treatment unnecessary for many NOA males. However, research suggests that anti-Mullerian hormone (AMH) and anogenital distance (AGD) may serve as predictors of positive SR at mTESE in NOA males. AGD, a marker of fetal androgen disruption and adult outcomes, may also assess male reproductive potential by predicting normal genital growth and sperm creation. A cross-sectional study found a positive correlation between AGD and total sperm count, concentration, and motility in infertile men aged 25-38, providing valuable prognostic insights for azoospermic men.
Detailed description
Azoospermia, which is defined as the lack of spermatozoa in the ejaculate, is a condition that affects around one percent of males and fifteen percent of men who are infertile. Sixty percent of azoospermic patients are affected by non-obstructive azoospermia, often known as NOA.
To harvest sperm for assisted reproductive technology (ART), this subset of men has no other choice except to undergo testicular sperm extraction (TESE) surgery.
Conventional TESE (cTESE) and microdissection TESE (mTESE) are the most preferred procedures in terms of sperm retrieval (SR) rates and the decrease of damage caused by excision. Studies have revealed varying percentages of positive SR, ranging from thirty percent to sixty percent.
This treatment is not necessary for a significant number of NOA boys because there are no biomarkers or procedures that are clinically acceptable that can predict a positive SR score at mTESE.
According to earlier research, anti-mullerian hormone (AMH), which is a homodimeric glycoprotein belonging to the family of transforming growth factor-b, has the potential to predict either a positive or negative significant difference (SR) at mTESE in iNOA. Throughout the course of development, Sertoli cells (SCs) secrete Amyloid-beta (AMH) in order to regress the Mullerian ducts and ensure that male sex differentiation occurs. AMH levels drop significantly when the development of puberty in males and the maturation of SCs occurs. It has been suggested that this hormone, which is solely produced by spermatocytes in males, can be used as an indirect marker of spermatogenesis, maturation of spermatocytes, and immaturity of the prepubertal testes.
A noninvasive method known as anogenital distance has recently been applied for the purpose of predicting and diagnosing disorders. There are two different measurements of the anogenital distance (AGD) for both men and women. AGD is a marker that indicates fetal androgen dysregulation as well as negative effects in adulthood. AGD is a unique method that can be used to evaluate the reproductive potential of males because it has the capacity to predict normal male genital growth and the production of sperm. It may also assist medical professionals in providing prognostic information to men who are azoospermic.
AGD AS was found to have a positive correlation with total sperm count, concentration, and motility in a cross-sectional study where the participants were infertile men between the ages of 25 and 38.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who have KS | – | Other: mTESE (microscopic testicular sperm extraction)Group one is patients with Klinefelter syndrome confirmed as 47, XXY on karyotyping undergoing mTESE for non-obstructive azoospermia |
| Patient who does not have KS | – | Other: mTESE (microscopic testicular sperm extraction)Group two consists of patients with a normal karyotyping undergoing mTESE for non-obstructive azoospermia |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Male patients with non-obstructive azoospermia of any age group suffering from infertility who did two successive semen analyses at least two weeks apart showing no sperms in ejaculate with normal or elevated gonadotrophic hormones and will undergo Testicular Sperm Extraction operation at Andrology Department, Kasr Al Ainy hospital Cairo University.
Key inclusion criteria (1 listed)
- All NOA patients underwent mTESE at the Andrology department, Kasr Al-Ainy hospitals
Key exclusion criteria (4 listed)
- patients with
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 |
|---|---|---|
| mTESE (microscopic testicular sperm extraction)Microdissection Testicular Sperm Extraction (mTESE) is a surgical procedure used to retrieve sperm from the testicles of men with non-obstructive azoospermia (NOA). It involves: 1. Testicular biopsy: Removing a small sample of testicular tissue. 2. Microscopic examination: Examining the tissue under a microscope to identify areas with sperm production. 3. Sperm extraction: Dissecting out individual sperm cells from the testicular tissue. This technique allows for: * More accurate identification of sperm-containing areas * Lower risk of damage to surrounding testicular tissue * Potential for higher sperm retrieval rates compared to conventional method | Other | Patient who does not have KS, patients who have KS |
Primary outcome
Relation of AGD of males with azoospermia (with or without KS) to mTESE outcome
Time frame: 1 months
Higher AGD might be correlated to higher sperm retrieval
Relation of AMH in males with azoospermia (with or without KS) to mTESE outcome
Time frame: 1 month
Higher AMH might be correlated to higher sperm retrieval
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Azoospermia Anogenital Distance AMH, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 2 May 2024. 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 Egypt. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relation of AGD of males with azoospermia (with or without KS) to mTESE outcome (time frame: 1 months). 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?
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 2 May 2024.