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

Feng Pan

Status and phase: Unknown; Phase 4

Conditions: Mycoplasma

Treatments: Procedure: IUI

Study type: Interventional

Funder types: Other

Identifiers

NCT01555047

NJU127

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 3 patient groups

males who were not infected by mycoplasma

Active Comparator group

Description:

100 male patients whose spouse was going to conduct IUI, was not infected by mycoplasma.

Treatment:

Procedure: IUI

Procedure: IUI

infected by mycoplasma males

Experimental group

Description:

100 male patients whose spouse was going to conduct IUI, was infected by mycoplasma.

Treatment:

Procedure: IUI

Procedure: IUI

fertile males

No Intervention group

Description:

50 fertile males were chose as control samples