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

Phase 4

• Conditions: Mycoplasma
• Interventions: Procedure: IUI

• Registration Number: NCT01555047
• Lead Sponsor: Feng Pan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-03-09
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-15
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-08
• Last Update Posted: 2013-04-10
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
infected by mycoplasma males	IUI	100 male patients whose spouse was going to conduct IUI, was infected by mycoplasma.
males who were not infected by mycoplasma	IUI	100 male patients whose spouse was going to conduct IUI, was not infected by mycoplasma.

Primary Outcome Measures

Name	Time	Method
pregnancy rate	up to 3 monthes after IUI

Secondary Outcome Measures

Name	Time	Method
sperm DNA fragmentation index (DFI)	one month before IUI