The Effect of Myo-inositol on fertility rates in Poor ovarian Responder Women undergoing Assisted Reproductive technique
Design
A randomized controlled clinical trial with double blinded parallel groups.
Randomization was centralized and computerized with concealed randomization sequence.
Settings and conduct
his study is performed on women with poor ovarian responder referred to infertility center of Bandar Abbas University of Medical Sciences.
All patients will receive infertility treatment with antagonist protocol after receiving the drug. After ovulation induction, the number of oocytes, fertilization rate and pregnancy rate are checked.
Blinding: People in the control group receive folic acid powder similar to the form of Inofolic produced by a reputable private pharmaceutical company. Both groups of patients, clinical researcher and data analyzer, do not know the type of treatment.
Participants/Inclusion and exclusion criteria
Infertile women of childbearing age referring to the Infertility Center who have one of the criteria of poor ovarian responder as bellow:
Antral follicle count less than 7
Anti-Mullerian hormone level Less than 1.2 ng / ml
Age over 40 years
Intervention groups
Intervention is myo-inositol.
Intervention group: Poor ovarian responder patients who receive Infolic powder (myoinositol + folic acid) 4g/daily-12 weeks.
Control group: Poor ovarian responder patients who receive folic acid 400mg/ daily-12 weeks.
Main outcome variables
Oocyte quality, oocytes number , Fertilization rate, Embryo quality, Clinical and Biochemical pregnancy rate, Abortion rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180515039668N1
Registration date:2020-03-16, 1398/12/26
Registration timing:retrospective
Last update:2020-03-16, 1398/12/26
Update count:0
Registration date
2020-03-16, 1398/12/26
Registrant information
Name
Fatemeh Eini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 7192
Email address
f.eini13@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
2019-03-21, 1398/01/01
Actual recruitment end date
2020-01-20, 1398/10/30
Trial completion date
2020-01-20, 1398/10/30
Scientific title
The Effect of Myo-inositol on fertility rates in Poor ovarian Responder Women undergoing Assisted Reproductive technique
Public title
The Effect of Myo-inositol on fertility rates in Poor ovarian Responder Women undergoing Assisted Reproductive technique
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All women of reproductive age with reduced ovarian reserve (number of Antral follicles less than 7)
All women of reproductive age with decreased in anti-mullerian hormone to less than 1.2 ng/ml
All women of reproductive age over than 40 years
Having one of the above criteria is a prerequisite for entry into the study
Exclusion criteria:
Presence of endocrine and metabolic disorders such as polycystic ovary syndrome, hyperprolactinemia, diabetes and thyroid dysfunction
Pelvic pathology such as hydrosalpinx, uterine anomaly
Stages III to IV endometriosis and fibroma
Male factors infertility such as Oligo-Astheno-Teratozoospermia (OAT) or Azoospermia
Age
From 20 years old to 43 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
58
Randomization (investigator's opinion)
Randomized
Randomization description
case of this study randomly assigned to two same groups in block balanced randomization using Random allocation software
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding: patients in the control group receive folic acid powder with the same appearance as that produced by a private pharmaceutical company. Patients in both treatment groups (myo-inositol) and control (folic acid) had the same treatment conditions and were randomly divided into two groups. The inclusion and exclusion criteria were the same for both groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Fertility and Infertility Research Center
Street address
Fertility and Infertility Research Center, Payambar Azam Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Approval date
2019-03-21, 1398/01/01
Ethics committee reference number
IR.HUMS.REC.1398.393
Health conditions studied
1
Description of health condition studied
Poor Ovarian Responder
ICD-10 code
E28.39
ICD-10 code description
Other primary ovarian failure
Primary outcomes
1
Description
Oocyte Quility
Timepoint
2-3 hr after oocyte collection
Method of measurement
Microscopic Evaluation
2
Description
Fertilization Rate
Timepoint
24 hr after Injection
Method of measurement
Microscopic Evaluation
Secondary outcomes
1
Description
Biochemical Pregnancy Rate
Timepoint
2 weeks after embryo transfer
Method of measurement
B-HCG evaluation
2
Description
Clinical pregnancy rate
Timepoint
7 weeks after embryo transfer
Method of measurement
Sonography for fetal heart rate
Intervention groups
1
Description
Intervention group: Daily oral administration of 4gr of ]nofolic powder (myoinositol + folic acid) for 12 weeks in patients with poor ovarian responder
Category
Treatment - Drugs
2
Description
Control group: Daily oral administration of 400 micrograms of folic acid powder for 12 weeks in patients with poor ovarian response
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Treatment Center of the Payambar Azam
Full name of responsible person
Dr Maryam Azizi
Street address
Jomhouri Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 0755
Email
Maryamazizikut86@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi kutenaei
Street address
Jomhouri Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519.
Phone
+98 76 3333 0755
Email
maryamazizikut86@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas University of Medical Sciences
Proportion provided by this source
50
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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi Kutenaei
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jomhouri
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 0755
Email
maryamazizikut86@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi Kutenaei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jomhouri
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 0757
Email
maryamazizikut86@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi Kutenaei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jomhouri
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 0755
Email
Maryamazizikut86@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD