Correlation Among Sperm DNA Fragmentation, Genitourinary Infection by Mycoplasma in Male and the Pregnancy Outcomes After IUI in Their Partner
|ClinicalTrials.gov Identifier: NCT01555047|
Recruitment Status : Unknown
Verified April 2013 by Feng Pan, Nanjing Medical University.
Recruitment status was: Active, not recruiting
First Posted : March 15, 2012
Last Update Posted : April 10, 2013
Information provided by (Responsible Party):
Feng Pan, Nanjing Medical University
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.
|Condition or disease||Intervention/treatment||Phase|
|Mycoplasma||Procedure: IUI||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Active Comparator: males who were not infected by mycoplasma
100 male patients whose spouse was going to conduct IUI, was not infected by mycoplasma.
Experimental: infected by mycoplasma males
100 male patients whose spouse was going to conduct IUI, was infected by mycoplasma.
No Intervention: fertile males
50 fertile males were chose as control samples
Primary Outcome Measures :
- pregnancy rate [ Time Frame: up to 3 monthes after IUI ]
Secondary Outcome Measures :
- sperm DNA fragmentation index (DFI) [ Time Frame: one month before IUI ]
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