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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01555047
Recruitment Status : Unknown
Verified April 2013 by Feng Pan, Nanjing Medical University.
Recruitment status was:  Active, not recruiting
First Posted : March 15, 2012
Last Update Posted : April 10, 2013
Information provided by (Responsible Party):
Feng Pan, Nanjing Medical University

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.

Condition or disease Intervention/treatment Phase
Mycoplasma Procedure: IUI Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. pregnancy rate [ Time Frame: up to 3 monthes after IUI ]

Secondary Outcome Measures :
  1. sperm DNA fragmentation index (DFI) [ Time Frame: one month before IUI ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

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Responsible Party: Feng Pan, Clinical Attending Doctor, Nanjing Medical University Identifier: NCT01555047     History of Changes
Other Study ID Numbers: NJU127
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: April 10, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Mycoplasma Infections
Lung Diseases
Respiratory Tract Diseases
Pleural Diseases
Respiratory Tract Infections
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections