Effects of Myo-inositol on IVF outcomes in poor responders undergoing intracytoplasmic sperm injection and comprission with folic acid:a randomised clinical trial
effect of myoinositol on oocyte number;
effect of myoinositol on pregnancy rate;
effect of myoinositol on abortion rate
Design
This randomized clinical trial is performed on148 infertile patients with low ovarian response .
Myoinositol 4 gr with Folic acid 400 microgram are administered in study gorup and placebo with Folic acid 400 microgram are administered one month before the cycle in two groups. . Ovarian stimulation with antagonist protocol will be started on day 2 or 3 of menstrual cycle in both groups. Embryo transfer will be done in day 2-3 after ICSI.
Settings and conduct
This clinical tria isl performed in Infertility and IVF ward, Taleghani hospital. 148 infertile patients with low ovarian response are recruited into the study in two groups according to randomization method. Myoinositol 4 gr with Folic acid 400 microgram administer in study gorup and placebo with Folic acid 400 microgram are administered one month before the cycle in two groups. Consent form were taken from participants were taken after awareness of them.Neither resercher and no participants didnot aware type of drug.
Participants/Inclusion and exclusion criteria
Age below 45 years; Body mass index (BMI) between 20-30; low ovarian reserve [both ovarian AFC below 7 or AMH below 1.1 ng/ml or low ovarian response in previous cycle (below 3 oocyte)]; none history of allergy to Myo-inositol Exclusion criteria: unwillingness to continue
Intervention groups
Administration inofolic in poor responder patients before IVF cycle:Administration of inofolic will start one month before IVF cycle and it will continue on stimulation phase.
Placebo and folic acid will administer in control group
Main outcome variables
Number of oocyte,clinical pregnancy,Abortion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160722029027N8
Registration date:2019-07-27, 1398/05/05
Registration timing:retrospective
Last update:2019-07-27, 1398/05/05
Update count:0
Registration date
2019-07-27, 1398/05/05
Registrant information
Name
Leila Nazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
nazari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Myo-inositol on IVF outcomes in poor responders undergoing intracytoplasmic sperm injection and comprission with folic acid:a randomised clinical trial
Public title
Effects of Myo-inositol in poor responder patients undergoing intracytoplasmic sperm injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Age below 45 years
Body mass index (BMI) between 20-30
low ovarian reserve [both ovarian AFC below 7 or AMH below 1.1 ng/ml or low ovarian response in previous cycle (below 3 oocyte)
none history of allergy to Myo-inositol
Exclusion criteria:
unwillingness to continue
Age
To 45 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
148
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were assigned into two groups, using permuted block randomization method with size of block of two. Package block rand in R statistical software was used for preparing randomization list.
Blinding (investigator's opinion)
Double blinded
Blinding description
this is a double-blinded study in which both patients and the conductor specialist were blinded about the contents of dug boxes. Each of drug boxes contains either Myo-inositol powder and placebo tablet (group A) or folic-acid tablet and placebo powder (group B). Neither specialist nor patients were informed about the boxes contents, just the drug company was informed about the study groups. Specialist assigned patients to one of these boxes according to the randomization list. In order to blind patients, no names was typed on the tablet or powder container.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Yaman St, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2016-04-19, 1395/01/31
Ethics committee reference number
IR.SBMU. MSP.REC.1395.20
Health conditions studied
1
Description of health condition studied
Noninflammatory disorders of female genital tract
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Number of metaphase II oocyte
Timepoint
Time of oocyte pick up
Method of measurement
According to embryolog criteria
2
Description
Chemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
Serum βHcG test
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
Transvaginal ultrasound
2
Description
Ongoing pregnancy
Timepoint
10 weeks after embryo transfer
Method of measurement
Vision fetal heart beat in ultrasound
Intervention groups
1
Description
Intervention group: Myoinositol 4 gr and Folic Acid 400 microgram was administered one month before the cycle and ovarian stimulation with antagonist protocol will be started on day 2 or 3 of menstrual cycle
Category
Treatment - Drugs
2
Description
Control group: Placebo and Folic Acid 400 microgram was administered one month before the cycle and ovarian stimulation with antagonist protocol will be started on day 2 or 3 of menstrual cycle
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility and IVF ward of Talghani hospital
Full name of responsible person
Leila Nazari
Street address
Yaman St, Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 31 5533 4611
Email
nazari@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Yaman st, Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 31 5533 4611
Email
nazari@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences