Correlation Among Sperm DNA Fragmentation, Genitourinary Infection by Mycoplasma in Male and the Pregnancy Outcomes After IUI in Their Partner
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 200
- Primary Endpoint
- pregnancy rate
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
males who were not infected by mycoplasma
100 male patients whose spouse was going to conduct IUI, was not infected by mycoplasma.
Intervention: IUI (Procedure)
infected by mycoplasma males
100 male patients whose spouse was going to conduct IUI, was infected by mycoplasma.
Intervention: IUI (Procedure)
fertile males
50 fertile males were chose as control samples
Outcomes
Primary Outcomes
pregnancy rate
Time Frame: up to 3 monthes after IUI
Secondary Outcomes
- sperm DNA fragmentation index (DFI)(one month before IUI)
Investigators
Feng Pan
Clinical Attending Doctor
Nanjing Medical University