An interventional study that is designed to evaluate the effect of probiotic treatment in intrauterine insemination
Design
Phase 3 clinical trial with a control group, parallel design, using the random allocation rule is performed on 194 patients.
Settings and conduct
This randomized study will be performed on 194 infertile women who refer to Yas Hospital, using a convenient sampling method. This study is performed single-blind, the gynecologist who does intrauterine insemination does not know the patient group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infertile women older than 18 years, candidate for intrauterine insemination with a History of at least twice failure in intrauterine insemination. Exclusion criteria: Bacterial vaginitis, withdrawal to participate in the study.
Intervention groups
In the intervention group, lactatovage suppository will be prescribed once per night two weeks before intrauterine insemination. In the control group, no extra intervention will be done.
Main outcome variables
Biochemical pregnancy and clinical pregnancy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130808014301N3
Registration date:2021-09-13, 1400/06/22
Registration timing:prospective
Last update:2021-09-13, 1400/06/22
Update count:0
Registration date
2021-09-13, 1400/06/22
Registrant information
Name
zahra rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8890 0002
Email address
rezaizah@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic treatment in infertile women who underwent intrauterine insemination in Yas hospital
Public title
The effect of probiotic treatment in infertile women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women older than 18 years
Candidate for intrauterine insemination
History of at least twice failure in intrauterine insemination
Exclusion criteria:
Bacterial vaginitis
Withdraw to participate in the study
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Care provider
Sample size
Target sample size:
194
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: First, 97 letters A and 97 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (intervention group) or B (control group) are determined by a lot.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is performed single-blind, the gynecologist who does intrauterine insemination does not know the patient group.
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
Tehran University of Medical Sciences, School of Medicine, Tehran Province, Tehran, Pour Sina St" to "Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2021-08-09, 1400/05/18
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.529
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Biochemical pregnancy
Timepoint
Once, two weeks after intrauterine insemination
Method of measurement
B HCG titrate
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
Once, four weeks after intrauterine insemination
Method of measurement
Pregnancy sac observation in transvaginal ultrasound
Intervention groups
1
Description
Intervention group: Lactatovage suppository will be prescribed once per night two weeks before intrauterine insemination. Then, the patients will be undergone intrauterine insemination.
Category
Treatment - Drugs
2
Description
Control group: Without extra interventions, the patients will be undergone intrauterine insemination.