Vaginal Profile in IVF/ICSI and Impact on Clincal Outcome | NCT04202302

Studies
Vaginal Profile in IVF/ICSI and Impact on Clincal Outcome

NCT04202302

Sponsor

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

Status

Unknown status

Last Update Posted

Dec 18, 2019Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Vaginal Flora Imbalance

Interventions

IVF/ICSI

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 6, 2019Actual

Primary Completion Date

Mar 2020Estimated

Completion Date

Mar 2020Estimated

First Submitted Date

Dec 15, 2019

First Submission Date that Met QC Criteria

Dec 15, 2019

First Posted Date

Dec 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2019

Last Update Posted Date

Dec 18, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Haiyan Lin, Principal Investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IVF/ICSI	Procedure	ovarian stimulation ，vaginal disinfection of flushing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical pregnancy rate	no. of clinical pregnancy / total number of embryo transfer cycles	12.2019-03.2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

The study population is from the infertility patients of reproductive center of Sun Yat-sen Memorial Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Haiyan Lin, Doctor	Contact	8602081332233		linhaiyan_818@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reproductive center of Sun Yat-sen memorial hospital	Recruiting	Guangzhou	Guangdong	510000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided