Effect of vaginal lactobacillus suppository on in-vitro fertilization (IVF) results in embryo transfer candidates referred to Hamadan Fatemieh Hospital: A double-blind, randomized, controlled, clinical trial
Patients will receive boxes sealed with 10-digit codes and containing the original drug or placebo, and they will not be aware of the type of drug received. The researcher will ensure the blinding of the patients as well as the attending physician. The intervention group will receive LactaVag suppositories, the placebo group, starch and microcrystalline cellulose suppositories vaginally two weeks before embryo transfer.
Participants/Inclusion and exclusion criteria
This study will be conducted on IVF candidate patients referred to the infertility center of Hamedan Fatemieh Hospital
Intervention groups
Two weeks before embryo transfer, the intervention group will receive LactaVag vaginal suppositories (Lactobacillus rhamnosus 10^9 CFU, Biotech Co., Tehran, Iran) and in the second arm (placebo group), two weeks before embryo transfer, placebo vaginal suppositories (starch and Microcrystalline cellulose) will be received.
Main outcome variables
In vitro fertilization (IVF) results
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230718058835N2
Registration date:2024-04-12, 1403/01/24
Registration timing:registered_while_recruiting
Last update:2024-04-12, 1403/01/24
Update count:0
Registration date
2024-04-12, 1403/01/24
Registrant information
Name
Seyed Ehsan Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 920 441 4305
Email address
mousavi.e@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-02, 1403/01/14
Expected recruitment end date
2024-10-05, 1403/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vaginal lactobacillus suppository on in-vitro fertilization (IVF) results in embryo transfer candidates referred to Hamadan Fatemieh Hospital: A double-blind, randomized, controlled, clinical trial
Public title
Effect of vaginal lactobacillus suppository on in-vitro fertilization (IVF) results
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 40 years
Maximum FSH level of 15 IU/ml
Absence of any systemic diseases (hypertension, diabetes, antiphospholipid syndrome, lupus, thrombophilia and thyroid diseases)
Normal uterine cavity with sufficient endometrial thickness of 7 mm
Absence of hydrosalpinx
Exclusion criteria:
Diagnosis of Asherman's syndrome
Diagnosis of polyps and fibroids by hysteroscopy
Refusal to participate in the study
Presence of chronic disease
The presence of vaginal infectious discharge
Receiving medical treatment chronically
Repeated IVF failure (more than 3 times in previous cycles)
Presence of clinical symptoms of vaginal infection
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization will be employed to allocate 30 participants into intervention and placebo groups. Using statistical software R, participants will be randomly assigned to either the intervention or placebo (control) group within predetermined blocks of size 6. The randomization process will involve generating random 10-digit numbers for each participant, ensuring a uniform distribution between 0 and 1, which will then be scaled to 10^10. Subsequently, participants will be sorted based on their generated random numbers within these blocks.
Participants in the intervention group will receive LactoVag vaginal suppositories two weeks before embryo transfer. In contrast, those in the control group will be provided with a Placebo vaginal suppository for the same duration. To maintain blinding throughout the study, each participant will receive a unique 10-digit code representing their allocated group. The suppositories will be packaged in sealed boxes labeled only with these codes, and neither participants nor data collectors will be aware of group allocation, minimizing bias. Physical methods, such as using opaque envelopes or sealed containers, will further ensure allocation concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and the physician will be blinded to allocation and the principal investigator will ensure the blinding of them.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Blvd, Pazhoohesh sq.
City
Hamedan
Province
Hamadan
Postal code
6517838736
Approval date
2023-04-29, 1402/02/09
Ethics committee reference number
IR.UMSHA.REC.1402.086
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.2
ICD-10 code description
Female infertility of uterine origin
Primary outcomes
1
Description
Chemical pregnancy rate
Timepoint
Two weeks after embryo transfer
Method of measurement
Serum level of β-HCG
Secondary outcomes
1
Description
Clinical pregnancy rate
Timepoint
4-6 weeks after embryo transfer
Method of measurement
Transvaginal ultrasound
Intervention groups
1
Description
Intervention group: LactoVag vaginal suppository (Lactobacillus rhamnosus10^9 CFU, Zist Takhmir Company, Tehran, Iran) two weeks before embryo transfer
Category
Treatment - Drugs
2
Description
Control group: Placebo vaginal suppository, a combination of starch and microcrystalline cellulose two weeks before embryo transfer.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemiyeh Hospital
Full name of responsible person
Roghaye Anvari Abad
Street address
Pasdaran
City
Hamedan
Province
Hamadan
Postal code
6517997178
Phone
+98 81 3827 7459
Email
h-fatemiyeh@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
Pazhoohesh sq, Shahid Fahmideh Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 4058
Email
Fanavari@umsha.ac.ir
Web page address
https://research.umsha.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyed Ehsan Mousavi
Position
researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No54, Mirzakuchakkhan str
City
Tabriz
Province
East Azarbaijan
Postal code
5166753383
Phone
+98 41 3332 1925
Email
drehsanmousavii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyed Ehsan Mousavi
Position
researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No54, Mirzakuchakkhan str.
City
Tabriz
Province
East Azarbaijan
Postal code
5166753383
Phone
+98 41 3332 1925
Email
drehsanmousavii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyed Ehsan Mousavi
Position
researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No54, Mirzakuchakkhan str.
City
Tabriz
Province
East Azarbaijan
Postal code
5166753383
Phone
+98 41 3332 1925
Email
drehsanmousavii@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available