Vaginal Profile in IVF/ICSI and Impact on Clincal Outcome

• Conditions: Vaginal Flora Imbalance

• Registration Number: NCT04202302
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-06
• Status Verified: 2019-12
• Study First Submitted: 2019-12-15
• Study First Submitted QC: 2019-12-15
• Last Update Submitted: 2019-12-16
• Study First Posted: 2019-12-17
• Last Update Posted: 2019-12-18
• Primary Completion: 2020-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	12.2019-03.2020	no. of clinical pregnancy / total number of embryo transfer cycles

Trial Locations

Locations (1)

Reproductive center of Sun Yat-sen memorial hospital; 🇨🇳 Guangzhou, Guangdong, China