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Lactobacillus for Luteal Phase Support

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04044599
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : March 24, 2020
Information provided by (Responsible Party):
GÜRKAN UNCU,PROF. MD, Uludag University

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.

Condition or disease Intervention/treatment Phase
IVF Drug: Gynoflor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lactobacillus for Luteal Phase Support to Improve IVF Outcomes
Estimated Study Start Date : March 30, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Study
Drug: Gynoflor

No Intervention: Control
Control group

Primary Outcome Measures :
  1. Implantation rate [ Time Frame: 4 weeks after embryo transfer ]
    To see the gestational sac

Secondary Outcome Measures :
  1. clinical pregnancy [ Time Frame: 6 weeks after embryo transfer ]
    To see the fetal cardiac activity

Other Outcome Measures:
  1. Ongoing pregnancy [ Time Frame: 12 weeks after embryo transfer ]
    Ongoing pregnancy after 12 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • having embryo transfer of a day 5 good quality embryo

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04044599

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Contact: Gurkan UNCU, Prof. 02242952541
Contact: Isil Kasapoglu, Specialist 02242952542

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Uludag University ART Center Recruiting
Bursa, Turkey
Contact: Gürkan Uncu, Prof.    02242952541   
Sponsors and Collaborators
Uludag University
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Study Director: Gurkan Uncu, Prof. Uludag University
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Responsible Party: GÜRKAN UNCU,PROF. MD, Prof. Dr. Gürkan Uncu, Uludag University Identifier: NCT04044599    
Other Study ID Numbers: 2019-11/24
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No