Determining the effect of inositol consumption on fertility in frozen embryo transfer cycles in people with polycystic ovary syndrome.
Design
Patients who meet the entry criteria will be randomly divided into two groups by block balanced randomization using the Random Allocation software.
Settings and conduct
The current research is a double-blind clinical trial study that will be conducted in Shahid Beheshti Hospital, Kashan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People with polycystic ovary syndrome who are between 20 and 40 years old and based on sonographic and laboratory findings included in the PCOS case file and based on infertility records are candidates for FET procedure at Shahid Beheshti Hospital Infertility Center. They are Kashan.
Intervention groups
According to coordination with the pharmacy of Shahid Beheshti Hospital in Kashan, the considered drugs are provided to the patients in two packages A and B. Patients in the control group will receive package A, which includes their routine medications, plus folic acid, which is produced with a similar appearance by a reputable pharmaceutical company, and patients in the intervention group will receive package B, which includes their routine medications plus inofolic. Patients in the control group will take folic acid for 8 weeks before the date of embryo transfer, and the intervention group will receive inofolic powder along with their routine medications for eight weeks.
Main outcome variables
Pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220809055652N1
Registration date:2023-09-22, 1402/06/31
Registration timing:retrospective
Last update:2023-09-22, 1402/06/31
Update count:0
Registration date
2023-09-22, 1402/06/31
Registrant information
Name
Zohreh Talebi Mazreshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 9258
Email address
talebi-z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-02, 1401/07/10
Expected recruitment end date
2022-11-01, 1401/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inositol on fertility in Frozen embryo transfer cycles in Poly cystic ovary syndrome
Public title
The effect of inositol on fertility in Frozen embryo transfer cycles in Poly cystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with polycystic ovary syndrome based on sonographic and laboratory findings.
Ages between 20 and 40 years old
Candidate to enter the FET procedure at Infertility Center of Shahid Beheshti Hospital, Kashan, based on infertility records.
Exclusion criteria:
People with uterine abnormalities (such as Asherman's syndrome, fibroids, polyps and adenomyosis diagnosis)
Inositol contraindications
Treatment cycles with embryo donation or prenatal genetic screening,
The mother is over 40 years old
Endometriosis
Unexplained Infertility
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
It will be done by simple random method and using lottery. Each patient will receive a number or code. We will write the numbers on pieces of paper. Then we will put the pieces of paper in a container and select the samples for the intervention and control groups according to the sample size from the numbers obtained from the lottery.
Blinding (investigator's opinion)
Double blinded
Blinding description
According to coordination with the pharmacy of Shahid Beheshti Hospital in Kashan, the considered drugs are provided to the patients in two packages A and B. Patients in the control group will receive package A, which includes their routine medications, plus folic acid, which is produced with a similar appearance by a reputable pharmaceutical company, and patients in the intervention group will receive package B, which includes their routine medications plus inofolic.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research of Faculty of Medicine, Kashan University of Medical Sciences
Street address
Faculty of Medicine, Kashan University of Medical Sciences, Qotb-e Ravandi Blvd, Kashan, Isfahan province, Iran. Post code:8715988111
City
Kashan
Province
Isfehan
Postal code
8715988111
Approval date
2022-07-26, 1401/05/04
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1401.072
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Fertility rate
Timepoint
Two months
Method of measurement
Clinical examination of pregnancy with the criterion of fetal heart observation in ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Control group: According to coordination with the pharmacy of Shahid Beheshti Hospital in Kashan, the drugs considered in this study are provided to the patients in two packages A and B. Patients in the control group received Package A, which included their own routine medications plus folic acid manufactured in a similar form by a reputable pharmaceutical company. These patients take folic acid for 8 weeks before the embryo transfer date, and then the embryo transfer is done with a suitable quality and the biochemical pregnancy rate (slight and temporary increase in B-hCG level), Clinical Pregnancy rate (observation of the fetus with activity heart in 6-7 weeks of pregnancy) and the rate of spontaneous abortion (pregnancy loss in 5-12 weeks of pregnancy) will be investigated in this group.
Category
Treatment - Drugs
2
Description
Intervention group: According to coordination with Shahid Beheshti Kashan hospital pharmacy, the drugs considered in this study are provided to the patients in two packages A and B. Patients in the intervention group will receive package B, which includes their routine medications along with inofolic. The patients of the intervention group received these drugs for eight weeks and then the embryo transfer was done with good quality and the amount of biochemical pregnancy (slight and temporary increase in B-hCG level), the amount of clinical pregnancy (observation of the fetus with cardiac activity in 6 weeks) 7-pregnancy) and the rate of spontaneous abortion (pregnancy loss in 5-12 weeks of pregnancy) will be investigated in this group.