This trial is active, not recruiting.

Condition mycoplasma
Treatments iui
Phase phase 4
Sponsor Feng Pan
Start date September 2011
End date December 2013
Trial size 200 participants
Trial identifier NCT01555047, NJU127


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
100 male patients whose spouse was going to conduct IUI, was not infected by mycoplasma.
intrauterine insemination
100 male patients whose spouse was going to conduct IUI, was infected by mycoplasma.
intrauterine insemination
(No Intervention)
50 fertile males were chose as control samples

Primary Outcomes

pregnancy rate
time frame: up to 3 monthes after IUI

Secondary Outcomes

sperm DNA fragmentation index (DFI)
time frame: one month before IUI

Eligibility Criteria

Male participants from 20 years up to 50 years old.

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.

Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Nanjing Medical University.