Mycoplasma Clinical Trial
| Verified date | April 2013 |
| Source | Nanjing Medical University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Ethics Committee |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 200 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 20 Years to 50 Years |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Feng Pan |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | pregnancy rate | up to 3 monthes after IUI | Yes | |
| Secondary | sperm DNA fragmentation index (DFI) | one month before IUI | Yes |