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Status unknownNCT01555047Updated Apr 10, 2013

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

A Phase 4 interventional study of IUI and IUI in Mycoplasma, sponsored by Feng Pan. Status unknown. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-10.

Sponsored by Feng Pan · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
20 Years to 50 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Mycoplasma

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03

In context

Mycoplasma Infections

10 studies on the registry are indexed under Mycoplasma Infections; 1 is open to participants now.

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Lead sponsor

Feng Pan is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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Inclusion criteria

  • Male with primary sterility with or without mycoplasma infection

Exclusion criteria

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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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • 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

  • Experimental
    infected by mycoplasma males

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

    Procedure: IUI

  • No intervention
    fertile males

    50 fertile males were chose as control samples

Interventions

  • ProcedureIUI

    intrauterine insemination

  • ProcedureIUI

    intrauterine insemination

06

What researchers measure

Primary outcomes

  1. pregnancy rate

    Time frame: up to 3 monthes after IUI

Secondary outcomes

  1. sperm DNA fragmentation index (DFI)

    Time frame: one month before IUI

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01555047
Lead sponsor
Feng Pan
Responsible party
Feng Pan (Clinical Attending Doctor, Nanjing Medical University) — Sponsor-investigator
First posted
Mar 15, 2012
Start date
Sep 2011
Primary completion
Dec 2013 (estimated)
Completion
Dec 2013 (estimated)
Last update
Apr 10, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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