The aim of this study is to determine the effects of pretreatment with myoinositol on oocyte quality in PCOS patients undergoing multiple follicular stimulation for IVF/ICSI.Results of this study will suggest an appropriate method which can be used for PCOS patients candidates for IVf with the least side effects and in shortest possible time.the study population are infertilized women with PCOS candidates for IVF.54 patients participate in this study which divided to 2 groups in a randomized controlled double blind trial.In one group the patients will take only folic acid 400 mg /day for 3 months and in the second group patients will take folic acid 400 mg/day +myoinositol 2000 mg for 3 months.after that both groups will enter to ovulation induction cycles by antagonist protocol.The result of cycles will be measured as OHSS event ,oocytes quantity and quality ,ovums and clinical pregnancy.One of the important inclusion criterias is normal sperm test and hysterosalpingography and the patients must not use any other medication during the study and do not have any underlying disease.the most important primary outcome measure is clinical pregnancy as outcome of cycles and OHSS event will be considered as the secondary outcome measure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021432525N2
Registration date:2017-04-30, 1396/02/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-30, 1396/02/10
Registrant information
Name
Shadrooz Moazzam
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 9782
Email address
st-moazzam.sh@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciemces
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effects of pretreatment with myoinositol on oocyte quality in PCOS patients undergoing
multiple follicular stimulation for IVF/ICSI
Public title
Study the effects of pretreatment with myoinositol on oocyte quality in patients with polycyctic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:infertile women with PCOS over 35 years old candidate for IVF procedure;normal sperm test and hysterosalpingography;agreement of patients for participation in the study.
exclusion criteria:patients must not use any other medication during the study;any other disease,history of abdomen and pelvic surgery,male infertility,abnormal hysterosalpingography or abnormal prolactin level;patiens leave the study on their own decision
Age
From 35 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Shahrekord University of Medical Sciences
Street address
Kashani street, Shahrekord
City
Shahrekord
Postal code
Approval date
2016-10-01, 1395/07/10
Ethics committee reference number
IR.SKUMS.REC.1395.116
Health conditions studied
1
Description of health condition studied
polycystic ovary syndrome disorder
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
cancelled cycles
Timepoint
3 months after intervention
Method of measurement
observation
2
Description
cycles which lead to freeze
Timepoint
3 months after intervention
Method of measurement
observation
3
Description
chemical and clinical pregnancy
Timepoint
3 months after intervention
Method of measurement
pregnacy proved by positive beta HCG test ,14 days after ovum transportation and sonography approved
4
Description
ovum grade
Timepoint
3 months after intervention
Method of measurement
A -D observation
5
Description
PVS quality
Timepoint
3 months after intervention
Method of measurement
observation
6
Description
ferilized egg
Timepoint
3 months after intervention
Method of measurement
observation
7
Description
zona pellucida quality
Timepoint
3 months after intervention
Method of measurement
observation
8
Description
cleavage rate
Timepoint
3 months after intervention
Method of measurement
observation
9
Description
metaphase II oocytes quality
Timepoint
3 months after intervention
Method of measurement
observation
10
Description
number of metaphase II oocytes
Timepoint
3 months after intervention
Method of measurement
observation
11
Description
number of atretic and immature oocytes (GV and metaphase II phases and degenerated oocytes)
Timepoint
3 months after intervention
Method of measurement
observation
Secondary outcomes
1
Description
hospitalization rate because of OHSS( ovary hyperstimulation syndrome)
Timepoint
3 months after intervention till end of pregnancy
Method of measurement
number of hospitalizations of patiens due to this reason ,observation