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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Mycoplasma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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males who were not infected by mycoplasma

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

Group Type ACTIVE_COMPARATOR

IUI

Intervention Type PROCEDURE

intrauterine insemination

infected by mycoplasma males

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

Group Type EXPERIMENTAL

IUI

Intervention Type PROCEDURE

intrauterine insemination

fertile males

50 fertile males were chose as control samples

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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IUI

intrauterine insemination

Intervention Type PROCEDURE

IUI

intrauterine insemination

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes