Vaginal Profile in IVF/ICSI and Impact on Clincal Outcome

December 16, 2019 updated by: Haiyan Lin, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Reproductive center of Sun Yat-sen memorial hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2019

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

December 15, 2019

First Submitted That Met QC Criteria

December 15, 2019

First Posted (Actual)

December 17, 2019

Study Record Updates

Last Update Posted (Actual)

December 18, 2019

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • SYSEC-KY-KS-2019-161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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