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

NCT01555047 | Unknown Phase 4 DMC

• 1 other identifier: NJU127
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mycoplasma

Outcome Measures

Primary Outcomes (1)

• pregnancy rate

  up to 3 monthes after IUI

Secondary Outcomes (1)

• sperm DNA fragmentation index (DFI)

  one month before IUI

Study Arms (3)

males who were not infected by mycoplasma

ACTIVE COMPARATOR

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

Procedure: IUI

infected by mycoplasma males

EXPERIMENTAL

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

Procedure: IUI

fertile males

NO INTERVENTION

50 fertile males were chose as control samples

Interventions

IUI PROCEDURE

intrauterine insemination

males who were not infected by mycoplasma

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male with primary sterility with or without mycoplasma infection

You may not qualify if:

• 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.

Sponsors & Collaborators

• Feng Pan: lead

MeSH Terms

Conditions

Mycoplasma Infections

Condition Hierarchy (Ancestors)

Mycoplasmatales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Attending Doctor

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: March 15, 2012
• Study Start: September 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 10, 2013

Record last verified: 2013-04