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CompletedNCT06396117KSUpdated May 2, 2024

Relationship Between Anogenital Distance, Serum AMH, and mTESE in Klinefelter Syndrome

An observational study in Azoospermia Anogenital Distance AMH, sponsored by Cairo University. Completed at 1 site in Egypt. Open to male participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-05-02.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
56
Ages
20 Years to 40 Years
Sex
Male
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Study 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. 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.

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Conditions studied

  • Azoospermia Anogenital Distance AMH

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03

In context

Azoospermia

59 studies on the registry are indexed under Azoospermia; 17 are open to participants now.

This study's enrollment of 56 is below the median of 95 across 24 observational studies indexed under Azoospermia.

Browse Azoospermia studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All NOA patients underwent mTESE at the Andrology department, Kasr Al-Ainy hospitals

Exclusion criteria

Exclusion Criteria:

  • patients with

    1. Obstructive azoospermia
    2. Retrograde Ejaculation
    3. Men with hypogonadotropic hypogonadism
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
56 participants (actual)
Patient registry
No

Groups and cohorts

  • patients who have KS

    Group one is patients with Klinefelter syndrome confirmed as 47, XXY on karyotyping undergoing mTESE for non-obstructive azoospermia

    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

    Other: mTESE (microscopic testicular sperm extraction)

Interventions

  • OthermTESE (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

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What researchers measure

Primary outcomes

  1. Relation of AGD of males with azoospermia (with or without KS) to mTESE outcome

    Higher AGD might be correlated to higher sperm retrieval

    Time frame: 1 months

  2. Relation of AMH in males with azoospermia (with or without KS) to mTESE outcome

    Higher AMH might be correlated to higher sperm retrieval

    Time frame: 1 month

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Study locations

1 site
  • Kasr Alainy
    Cairo, Please Select A Region, State Or Province. 11231, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06396117
Lead sponsor
Cairo University
Responsible party
Mohamed Wael Ragab (Lecturer, Cairo University) — Principal investigator
First posted
May 2, 2024
Start date
Mar 1, 2023
Primary completion
Jan 1, 2024
Completion
Feb 1, 2024
Last update
May 2, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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