NCT04202302

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

December 18, 2019

Status Verified

December 1, 2019

Enrollment Period

7 months

First QC Date

December 15, 2019

Last Update Submit

December 16, 2019

Conditions

Vaginal Flora Imbalance

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    no. of clinical pregnancy / total number of embryo transfer cycles

    12.2019-03.2020

Interventions

IVF/ICSIPROCEDURE

ovarian stimulation ，vaginal disinfection of flushing

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive center of Sun Yat-sen memorial hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

Central Study Contacts

Haiyan Lin, Doctor

CONTACT

8602081332233linhaiyan_818@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 15, 2019

First Posted

December 17, 2019

Study Start

August 6, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

December 18, 2019

Record last verified: 2019-12

Locations

CN(1)