Correlation Among Sperm DNA Fragmentation, Genitourinary Infection by Mycoplasma in Male and the Pregnancy Outcomes After IUI in Their Partner

Study Overview
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Brief Summary
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Genital ureaplasmas (Ureaplasma urealyticum and Ureaplasma parvum) and genital mycoplasmas (Mycoplasma hominis and Mycoplasma genitalium) are natural inhabitants of the male urethra contaminating the semen during ejaculation. However, these microorganisms, especially Ureaplasma urealyticum (Uu) and Mycoplasma hominis (Mh), are potentially pathogenic species playing an etiologic role in both genital infections and male infertility. Despite there are many consentaneous opinions about its relationship with infertility, its correlation with sperm regular parameters is still controversially. Sperm DNA damage can negatively influence fertilization rate, embryo cleavage rate, implantation rate, pregnancy and live birth rate, and is a novel indicator for intrauterine insemination (IUI) pregnancy rate and IVF or ICSI pregnancy loss rate. Until now, there were fewer clinical researches about the relationship among Uu and/or Mh infection, sperm DNA damage, and the IUI pregnancy rate. Thus, the investigators conduct this prospective study to investigate the relationship among them.

Conditions
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Mycoplasma

Intervention / Treatment
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* Procedure: IUI
* Procedure: IUI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male with primary sterility with or without mycoplasma infection Exclusion Criteria: Combination with chlamydial infection History of using hormone or cytotoxic drugs. Having some other surgical diseases, such as genital tract infection or varicocele Having some congenital diseases, such as Klinefelter and Y chromosome deficiency Having some endocrine diseases, such as Kallmann, abnormality in pituitary gland, hyperthyroidism, hypercorticoidism, and so on Patients' spouse had some diseases that could not carry out spontaneous pregnancy, such as tubal obstruction or ovulatory failure.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: males who were not infected by mycoplasma<br>100 male patients whose spouse was going to conduct IUI, was not infected by mycoplasma. | Procedure: IUI<br>* intrauterine insemination<br>|
| Experimental: infected by mycoplasma males<br>100 male patients whose spouse was going to conduct IUI, was infected by mycoplasma. | Procedure: IUI<br>* intrauterine insemination<br>|
| No Intervention: fertile males<br>50 fertile males were chose as control samples | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate |  | up to 3 monthes after IUI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sperm DNA fragmentation index (DFI) |  | one month before IUI |