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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Feng Pan, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01555047
First received: March 9, 2012
Last updated: April 8, 2013
Last verified: April 2013

March 9, 2012
April 8, 2013
September 2011
December 2013   (final data collection date for primary outcome measure)
pregnancy rate [ Time Frame: up to 3 monthes after IUI ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01555047 on ClinicalTrials.gov Archive Site
sperm DNA fragmentation index (DFI) [ Time Frame: one month before IUI ] [ Designated as safety issue: Yes ]
Same as current
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Correlation Among Sperm DNA Fragmentation, Genitourinary Infection by Mycoplasma in Male and the Pregnancy Outcomes After IUI in Their Partner
Not Provided

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.

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Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Mycoplasma
Procedure: IUI
intrauterine insemination
  • Active Comparator: males who were not infected by mycoplasma
    100 male patients whose spouse was going to conduct IUI, was not infected by mycoplasma.
    Intervention: Procedure: IUI
  • Experimental: infected by mycoplasma males
    100 male patients whose spouse was going to conduct IUI, was infected by mycoplasma.
    Intervention: Procedure: IUI
  • No Intervention: fertile males
    50 fertile males were chose as control samples
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male with primary sterility with or without mycoplasma infection

Exclusion Criteria:

  1. Combination with chlamydial infection
  2. History of using hormone or cytotoxic drugs.
  3. Having some other surgical diseases, such as genital tract infection or varicocele
  4. Having some congenital diseases, such as Klinefelter and Y chromosome deficiency
  5. Having some endocrine diseases, such as Kallmann, abnormality in pituitary gland, hyperthyroidism, hypercorticoidism, and so on
  6. Patients' spouse had some diseases that could not carry out spontaneous pregnancy, such as tubal obstruction or ovulatory failure.
Male
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01555047
NJU127
Yes
Feng Pan, Nanjing Medical University
Feng Pan
Not Provided
Not Provided
Nanjing Medical University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP