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NCT04202302 Clinical Trial

Vaginal Profile in IVF/ICSI and Impact on Clincal Outcome

Vaginal Flora Imbalance Clinical Trial

Official title:
The Impact of Vaginal Profile During Ovarian Stimulation on the IVF/ICSI Outcome: a Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04202302
Other study ID # SYSEC-KY-KS-2019-161
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 6, 2019
Est. completion date March 2020

Study information
Verified date December 2019
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Haiyan Lin, Doctor
Phone 8602081332233
Email linhaiyan_818@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date March 2020
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• IVF/ICSI
ovarian stimulation ,vaginal disinfection of flushing

Locations
Country Name City State
China Reproductive center of Sun Yat-sen memorial hospital Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary clinical pregnancy rate no. of clinical pregnancy / total number of embryo transfer cycles 12.2019-03.2020
See also
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