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

Primary Purpose

Mycoplasma

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

IUI

About this trial

This is an interventional treatment trial for Mycoplasma

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Male with primary sterility with or without mycoplasma infection

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

males who were not infected by mycoplasma

infected by mycoplasma males

fertile males

Arm Description

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

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

50 fertile males were chose as control samples

Outcomes

Primary Outcome Measures

pregnancy rate

Secondary Outcome Measures

sperm DNA fragmentation index (DFI)

Full Information

NCT ID

NCT01555047

First Posted

March 9, 2012

Last Updated

April 8, 2013

Sponsor

Feng Pan

1. Study Identification

Unique Protocol Identification Number

NCT01555047

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Feng Pan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mycoplasma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

males who were not infected by mycoplasma

Arm Type

Active Comparator

Arm Description

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

Arm Title

infected by mycoplasma males

Arm Type

Experimental

Arm Description

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

Arm Title

fertile males

Arm Type

No Intervention

Arm Description

50 fertile males were chose as control samples

Intervention Type

Procedure

Intervention Name(s)

IUI

Intervention Description

intrauterine insemination

Intervention Type

Procedure

Intervention Name(s)

IUI

Intervention Description

intrauterine insemination

Primary Outcome Measure Information:

Title

pregnancy rate

Time Frame

up to 3 monthes after IUI

Secondary Outcome Measure Information:

Title

sperm DNA fragmentation index (DFI)

Time Frame

one month before IUI

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male with primary sterility with or without mycoplasma infection Exclusion Criteria: 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.

12. IPD Sharing Statement

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

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