Correlation Among Sperm DNA Fragmentation, Genitourinary Infection by Mycoplasma in Male and the Pregnancy Outcomes After IUI in Their Partner
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Mycoplasma |
Procedure: IUI |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
- pregnancy rate [ Time Frame: up to 3 monthes after IUI ] [ Designated as safety issue: Yes ]
- sperm DNA fragmentation index (DFI) [ Time Frame: one month before IUI ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: males who were not infected by mycoplasma
100 male patients whose spouse was going to conduct IUI, was not infected by mycoplasma.
|
Procedure: IUI
intrauterine insemination
|
|
Experimental: infected by mycoplasma males
100 male patients whose spouse was going to conduct IUI, was infected by mycoplasma.
|
Procedure: IUI
intrauterine insemination
|
|
No Intervention: fertile males
50 fertile males were chose as control samples
|
Eligibility| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders Eligible for Study: | 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Feng Pan, Clinical Attending Doctor, Nanjing Medical University |
| ClinicalTrials.gov Identifier: | NCT01555047 History of Changes |
| Other Study ID Numbers: | NJU127 |
| Study First Received: | March 9, 2012 |
| Last Updated: | April 8, 2013 |
| Health Authority: | China: Ethics Committee |
Additional relevant MeSH terms:
|
Pleuropneumonia Mycoplasma Infections Pneumonia Lung Diseases Respiratory Tract Diseases Pleurisy |
Pleural Diseases Respiratory Tract Infections Mycoplasmatales Infections Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 19, 2013