Lactobacillus for Luteal Phase Support

IVF Clinical Trial

Official title:

Lactobacillus for Luteal Phase Support to Improve IVF Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04044599
• Other study ID #: 2019-11/24
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: March 2020
• Source: Uludag University
• Contact: Gurkan UNCU, Prof.
• Phone: 02242952541
• Email: guncu[@]gurkanuncu.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• IVF

Intervention

Drug:
• Gynoflor
VAGINAL GYNOFLOR

Locations

Country	Name	City	State
Turkey	Uludag University ART Center	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ongoing pregnancy	Ongoing pregnancy after 12 weeks	12 weeks after embryo transfer
Primary	Implantation rate	To see the gestational sac	4 weeks after embryo transfer
Secondary	clinical pregnancy	To see the fetal cardiac activity	6 weeks after embryo transfer