CClinicalTrials.gg
Status unknownNCT04044599Updated Mar 24, 2020

Lactobacillus for Luteal Phase Support

An interventional study of Gynoflor in IVF, sponsored by Uludag University. Status unknown at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-24.

Sponsored by Uludag University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the detailed description

Urogenital region accounts for 9% of the total human microbiome. The role of vaginal microbioma in infertility and assisted reproductive technologies has not yet been clarified. It is thought that microorganisms such as mycoplasma, chlamydia and Neiseria gonorrhea are associated with infertility, and changes in subclinical microbiota such as bacterial vaginosis (BV) may be a risk factor for subfertility. The majority of the normal elements of the vaginal flora are the various Lactobacillus species. Lactobacilli constitute a healthy environment for the embryo in the pre- and peri-conception period. They are thought to support implantation not only by their presence but also by the lactic acid, hydrogen peroxide, bacteriocin and probiotics they produce. Bacterial vaginosis (BV) is the reduction of lactobacilli in the dominance of the vaginal microbiota and the transition of the microbial environment to the dominance of Gardnella vaginalis.The two main functions of lactobacilli in translating the balances in the reproductive system in favor of successful implantation and pregnancy rates; lactic acid production and H 2 O 2 recovery. It has been shown that up to 40% of patients undergoing in vitro fertilization (IVF) cycles have abnormal reproductive tract microbiata. To date, studies on vaginal microbiata and implantation have been carried out to identify vaginal microbiome by genetic sequencing of the vaginal specimens. In these studies, endometrial microbiota; When lactobacilli were classified as dominant (> 90%) and non-lactobacilli were dominant; In the presence of lactobacilli non-dominant microbiota, decreased implantation, pregnancy and ongoing pregnancy rates and more negative reproductive results were obtained.

To date, the limited number of studies evaluating the effects of lactobacilli on assisted reproductive methods success and implantation; vaginal or endometrial lactobacilli burden was evaluated. Therefore, for the first time in our study; 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.The study group will be composed of patients who will receive 4 vaginal lactobacillus tablet immediately after the OPU procedure.The ones who will not receive vaginal lactobacillus tablets will compose the control group.

Patients will be selected from infertile patients that underwent IVF/ICSI protocol. There will be no change in the routine ovarian stimulation protocols and luteal phase support treatments that patients should receive routinely. Following ovulation induction with controlled ovarian stimulation (KOH), which is routinely administered in IVF treatment cycles, following the collection of oocytes, the luteal phase support is routinely recommended for the preparation of the endometrium to embryo transfer in artificial, stimulated cycles on the evening of the same day. If pregnancy occurs, luteal phase support should be continued for an average of 8 weeks. In fresh embryo transfer cycles, vaginal progesterone is routinely used for luteal phase support in all patients in our clinic. All patients will receive the same luteal phase treatment routinely.For the study the patients who will have day 5 good quality embryo transfer performed will be selected.

02

Conditions studied

  • IVF
03

In context

Lead sponsor

Uludag University is the lead sponsor of 141 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • having embryo transfer of a day 5 good quality embryo

Exclusion criteria

Exclusion Criteria:

  • Uterin pathologies
  • Having additional adjuvants for luteal phase support
  • Having day 3 embryo transfer
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Study

    THE GROUP THAT WİLL RECİEVE VAGİNAL LACTOBACİLLUS

    Drug: Gynoflor

  • No intervention
    Control

    Control group

Interventions

  • DrugGynoflor

    VAGİNAL GYNOFLOR

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What researchers measure

Primary outcomes

  1. Implantation rate

    To see the gestational sac

    Time frame: 4 weeks after embryo transfer

Secondary outcomes

  1. clinical pregnancy

    To see the fetal cardiac activity

    Time frame: 6 weeks after embryo transfer

Other outcomes

  1. Ongoing pregnancy

    Ongoing pregnancy after 12 weeks

    Time frame: 12 weeks after embryo transfer

07

Study locations

1 of 1 sites recruiting
  • Uludag University ART Center
    Bursa, Turkey
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04044599
Lead sponsor
Uludag University
Responsible party
GÜRKAN UNCU,PROF. MD (Prof. Dr. Gürkan Uncu, Uludag University) — Principal investigator
First posted
Aug 5, 2019
Start date
Mar 30, 2020 (estimated)
Primary completion
Jun 1, 2020 (estimated)
Completion
Jun 1, 2020 (estimated)
Last update
Mar 24, 2020

Study contacts

Gurkan UNCU, Prof.
Contact
guncu@gurkanuncu.org
02242952541
Isil Kasapoglu, Specialist
Contact
kasapogluisil@hotmail.com
02242952542
Gurkan Uncu, Prof.
study director · Uludag University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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