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Vaginal Profile in IVF/ICSI and Impact on Clincal Outcome

NCT ID: NCT04202302

Last Updated: 2019-12-18

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

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-06

Study Completion Date

2020-03-31

Brief Summary

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Vaginal flora is closely related to female reproductive health. Previous studies have suggested that the composition of the vaginal flora is related to the pregnancy outcomes, and abnormalities in the vaginal flora lead to a decrease in the success rate of IVF. During the IVF treatment, the hormone level changes far exceed the physiological level. What changes will happen to the vaginal flora? Does IVF treatment itself affect the vaginal flora and affect outcomes? This study used prospective cohort study to show the changes in vaginal flora during conventional IVF treatment, providing more evidence for revealing the relationship between vaginal flora and infertility treatment outcomes.

Detailed Description

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Conditions

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Vaginal Flora Imbalance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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IVF/ICSI

ovarian stimulation ，vaginal disinfection of flushing

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 20-40 years old
* BMI\<30kg/m2
* First IVF/ICSI cycle (GnRH agonist or antagonist protocol)
* no vaginitis after recruitment
* completion of oocyte retrieval

Exclusion Criteria

* history of RSA
* history of endometriosis
* Immune diseases such as SLE, etc., and the use of immunosuppressive agents, glucocorticoids, etc.
* obvious hydrosalpinx(\>2cm in diameter by ultrasound)
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Haiyan Lin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Reproductive center of Sun Yat-sen memorial hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haiyan Lin, Doctor

Role: CONTACT

Phone: 8602081332233

Email: [email protected]

Facility Contacts

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Haiyan Lin, Doctor

Role: primary

Other Identifiers

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SYSEC-KY-KS-2019-161

Identifier Type: -

Identifier Source: org_study_id