Protocol summary

Study aim
The effect of vaginal probiotic administration on the consequences of embryo transfer, microbial culture of the uterine cavity and vagina
Design
A randomized controlled clinical trial with parallel, double-blind, randomized groups.
Settings and conduct
In this study, about 153 people are randomly placed into two groups of 77 and 76 people. Unlike the control group, the intervention group will be given Lactovagin capsules. After the preparation of the endometrium, the embryo transfer process is performed. It is done in Shariati Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: infertile women between the ages of 18 and 40, no underlying diseases, no uterine anomalies, and no history of any surgery on the uterus and cervix. Exclusion criteria: the presence of underlying disease, the presence of uterine anomalies, drug use, and male infertility, the use of broad-spectrum antibiotics, hormonal drugs, alcohol, anticoagulants, immunosuppressive drugs, and corticosteroids during the last month.
Intervention groups
From the beginning of the embryo transfer cycle, Lactovage capsules are prescribed once vaginally for one month. Preparation of the endometrium with conjugated estrogen starts from the second day of menstruation, after the thickness of the endometrium reaches the appropriate level by performing serial transvaginal ultrasound; Patients receive rectal progesterone suppositories for 4 days. In the control group, preparation of the endometrium with conjugated estrogen started from the second day of menstruation after the thickness of the endometrium reached the appropriate level by performing serial transvaginal ultrasound; Patients receive rectal progesterone suppositories for 4 days
Main outcome variables
Diversity of microbial cultures of the uterine cavity and vagina

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110602006689N5
Registration date: 2024-06-03, 1403/03/14
Registration timing: prospective

Last update: 2024-06-03, 1403/03/14
Update count: 0
Registration date
2024-06-03, 1403/03/14
Registrant information
Name
Sedigheh Hosseinimousa
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 8810
Email address
hoseinimosa@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-23, 1403/04/03
Expected recruitment end date
2025-02-13, 1403/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of vaginal probiotic administration on the consequences of embryo transfer, microbial culture of the uterine cavity and vagina in infertile women undergoing frozen embryo transfer at Shariati Hospital, Tehran University of Medical Sciences.
Public title
Investigating the effect of vaginal probiotics on the consequences of embryo transfer, microbial culture of the uterine cavity and vagina in infertile women undergoing embryo transfer.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women between the ages of 18 and 40 are candidates for frozen embryo transfer Not suffering from diseases such as liver disease, heart disease, kidney disease, diabetes, nervous system diseases, defects, immune system, sexually transmitted diseases No history of any surgery on the uterus and cervix Absence of uterine anomalies Having normal menstrual cycles (between 21 and 35 days)
Exclusion criteria:
Smoking and alcohol use male infertility Autoimmune diseases, uterine fibroids > 4 cm Uterine anomalies History of any surgery on the uterus and cervix Over 40 years old Presence of fibroma with pressure effect on endometriosis History of three unsuccessful embryo transfers Use of broad-spectrum antibiotics, hormonal drugs, anticoagulants, and immunosuppressive drugs and corticosteroids during the last month.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 156
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups. To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks. For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit. Here, based on the block, we divide 4 people into groups. 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1936893813
Approval date
2022-01-09, 1400/10/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1176

Health conditions studied

1

Description of health condition studied
Microbial culture of the uterine cavity and vagina
ICD-10 code
N80
ICD-10 code description
Endometriosis

Primary outcomes

1

Description
Diversity of microbial cultures of the uterine cavity and vagina
Timepoint
Before and after the intervention
Method of measurement
Microbial culture

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: From the beginning of the embryo transfer cycle, Lactovage capsules are prescribed once vaginally for one month. Preparation of the endometrium with conjugated estrogen starts from the second day of menstruation, after the thickness of the endometrium reaches the appropriate level by performing serial transvaginal ultrasound; Patients receive rectal progesterone suppositories for 4 days and then embryos with grade A, B and A-B are transferred.
Category
Treatment - Drugs

2

Description
Control group: Lactovagin suppositories are not given to the control group. Then, preparation of the endometrium with conjugated estrogen started from the second day of menstruation after the thickness of the endometrium reaches the appropriate level by performing serial transvaginal ultrasound; Patients receive rectal progesterone suppositories for 4 days and then embryos with grade A-B, A and B are transferred.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility Unit, Shariati Hospital
Full name of responsible person
Dr. Sedighe Hosseinimousa
Street address
Department of Infertility, Shariati Hospital, Tehran University of Medical Sciences, North Karegar Street
City
Tehran
Province
Tehran
Postal code
1466938664
Phone
+98 21 8822 0050
Email
hoseinimosa@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Shahin Akhoondzadeh
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8822 0050
Email
ivfshariati69@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Sedighe Hoseinimosa
Position
Infertility Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Email
hoseinimosa@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sedighe Hoseinimosa
Position
Infertility Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Email
hoseinimosa@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sedighe Hoseinimosa
Position
Infertility Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Email
hoseinimosa@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Starting 9 months after publication
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
No other condition is considered
From where data/document is obtainable
hoseinimosa@sina.tums.ac.ir
What processes are involved for a request to access data/document
1 year
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