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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Feng Pan, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01555047
First received: March 9, 2012
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Mycoplasma
Procedure: IUI
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • pregnancy rate [ Time Frame: up to 3 monthes after IUI ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • sperm DNA fragmentation index (DFI) [ Time Frame: one month before IUI ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: males who were not infected by mycoplasma
100 male patients whose spouse was going to conduct IUI, was not infected by mycoplasma.
Procedure: IUI
intrauterine insemination
Experimental: infected by mycoplasma males
100 male patients whose spouse was going to conduct IUI, was infected by mycoplasma.
Procedure: IUI
intrauterine insemination
No Intervention: fertile males
50 fertile males were chose as control samples

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Feng Pan, Clinical Attending Doctor, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01555047     History of Changes
Other Study ID Numbers: NJU127
Study First Received: March 9, 2012
Last Updated: April 8, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Pleuropneumonia
Mycoplasma Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Pleurisy
Pleural Diseases
Respiratory Tract Infections
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 31, 2014