NCT04044599

Brief Summary

The aim of this study was to evaluate the effect of vaginal lactobacilli, a regulator of normal vaginal flora, on embryo implantation success during IVF / ICSI cycle follow-up.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

August 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

March 30, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

August 1, 2019

Last Update Submit

March 23, 2020

Conditions

IVF

Outcome Measures

Primary Outcomes (1)

  • Implantation rate

    To see the gestational sac

    4 weeks after embryo transfer

Secondary Outcomes (1)

  • clinical pregnancy

    6 weeks after embryo transfer

Other Outcomes (1)

  • Ongoing pregnancy

    12 weeks after embryo transfer

Study Arms (2)

Study

EXPERIMENTAL

THE GROUP THAT WİLL RECİEVE VAGİNAL LACTOBACİLLUS

Drug: Gynoflor

Control

NO INTERVENTION

Control group

Interventions

GynoflorDRUG

VAGİNAL GYNOFLOR

Study

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • having embryo transfer of a day 5 good quality embryo

You may not qualify if:

  • Uterin pathologies
  • Having additional adjuvants for luteal phase support
  • Having day 3 embryo transfer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uludag University ART Center

Bursa, Turkey (Türkiye)

RECRUITING

Study Officials

  • Gurkan Uncu, Prof.

    Uludag University

    STUDY DIRECTOR

Central Study Contacts

Gurkan UNCU, Prof.

CONTACT

02242952541guncu@gurkanuncu.org

Isil Kasapoglu, Specialist

CONTACT

02242952542kasapogluisil@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Gürkan Uncu

Study Record Dates

First Submitted

August 1, 2019

First Posted

August 5, 2019

Study Start

March 30, 2020

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations

TU(1)