Protocol summary

Study aim
Vaginal microbial supplement on FET cycles
Design
Randomized clinical trial
Settings and conduct
This study is a clinical trial. Participants will be selected from infertile patients under the age of 40 who are referred to the Yas Infertility Center who are candidates for embryo transfer. Patients with genetic disease diagnosed in their own or spouse, people with a specific systemic or chronic disease (diabetes, hypertension, endocrine problems, autoimmune diseases, endometriosis, etc.) are excluded. All embryos have been frozen in quality a and b. On this basis, 90 patients were enrolled in the study and randomly divided into two groups of experimental and control groups. Two weeks before the start of the cycle, patients undergo vaginal examination. In the event of any vaginal infection, they were excludedl. Then, in the experimental group, the vaginal microbial suppository (lactate) as a nocturnal adminstrated for one week. Then, on the second day of mens, they will refer to endometrial preparations. In the control group, patients do not receive microbial supplements, and on the second day they refer to the uterus for freeze transfer. The process of endometrial preparation is according to the current protocol. According to the age of the patient, 1 to 3 fetuses a and b are transmitted to the uterus on the fifth day. In case of severe and severe transfusion, or return of the fetus to the catheter, the patient is excluded from the study. After that, the outcome of pregnancy will be compared to the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All candidate for FET cycle, embryo grade A orB Exclusion criteria: Genetic dis., diabetes, hypertension,endometriosis, autoimmune dis.
Intervention groups
All the patients who are candidate for frozen embryo transfer
Main outcome variables
Chemical ,clinical pregnancy rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091012002576N17
Registration date: 2019-04-06, 1398/01/17
Registration timing: registered_while_recruiting

Last update: 2019-04-06, 1398/01/17
Update count: 0
Registration date
2019-04-06, 1398/01/17
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pretreatment with vaginal microbial supplement on the outcomes of freeze-embryo transfer cycles in infertile women
Public title
The effect of pretreatment with vaginal microbial supplement on the outcomes of freeze-embryo transfer cycles in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having freeze embryos from the previous IVF cycle Age 20 to 40 years old lack of anatomical lesions in the uterus absence of vaginitis and cervicitis
Exclusion criteria:
Patients with known genetic disease on their own or spouse People with certain systemic or chronic diseases (diabetes, hypertension, endocrine problems, autoimmune diseases, endometriosis, etc.) Embryos that frozen more than 5 years. Embryos with poor quality after thowing Vaginal infection or cervicitis
Age
From 20 years old to 40 years old
Gender
Female
Phase
4
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Random Number Tables
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are included according to the table of random numbers. In the patient group, the lactobacterial suppository is taken daily two weeks before the start of the study. The control group does not use any drug before endometrial preparation. Subsequently, both groups are included in the standard regime for frozen embryo transfer. in both groups embryo transfer performs by embryologist in blind, then 14 days later, the result of the pregnancy test is reported.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of the Tehran University of Medical Sciences
Street address
Yas hospital, North Ostadnejatollahi, Karimkhan Bridge, Villa street
City
Tehran
Province
Tehran
Postal code
1597856511
Approval date
2018-12-30, 1397/10/09
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.657

Health conditions studied

1

Description of health condition studied
Recurrent IVF failure
ICD-10 code
E00-E90
ICD-10 code description
Recurrent IVF failure

Primary outcomes

1

Description
embryo implantation
Timepoint
2 weeks
Method of measurement
B HCG titrage

Secondary outcomes

1

Description
Checking gestational sac in ultrasound
Timepoint
4 weeks
Method of measurement
ultrasound

Intervention groups

1

Description
Intervention group: forty five patients include in the case group and received lactatovage suppository two weeks before embryo transfer.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
the infertility center at Yas hospital
Full name of responsible person
Dr Fatemeh Davari tanha
Street address
North Ostad Nejatollahi- Villa street, Karimkhan Bridge
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9076
Fax
+98 21 8894 8217
Email
fatedavtanha@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Miss Atefeh Ahmadi خانم عاطفه احمدی
Street address
Deputy research of TUMS; Fifth floor of Central building of Tehran University of Medical Sciences, Ghodse Avenue, Keshavarz Boulvard
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9076
Email
fatedavtanha@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
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas Hospital- North nejatollahi Ave., Villa street, Karimkhan Bridge
City
Tehran
Province
Tehran
Postal code
15978
Phone
+98 21 8880 0611
Email
fatedavtanha@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas Hospital- North Nejatollahi Ave- Villa street- Karimkhan Bridge
City
Tehran
Province
Tehran
Postal code
15978
Phone
+98 88800611
Email
fatedavtanha@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas Hospital- North nejatollahi ave.,Villa street- Karimkhan zand Bridge
City
Tehran
Province
Tehran
Postal code
15978
Phone
+98 88800611
Email
fatedavtanha@gmail.com

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 anonymously are available
When the data will become available and for how long
After completing study at 2020 and for one year
To whom data/document is available
All medical researchers
Under which criteria data/document could be used
After confirmation of author, every analysis is permitted
From where data/document is obtainable
Deputy research of Tehran University of Medical Sciences
What processes are involved for a request to access data/document
Asking from research employee at deputy of research in TUMS
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