The aim of this study is to evaluate the effect of dietary based on traditional medicine on the results of assisted reproductive technology (ART). For this purpose, the traditional meal plan is designed based on the Iranian traditional medicine and its evaluation is performed by using a randomized clinical trial. The candidates of IVF/ICSI referring to Shahrekord infertility center, who causes of their infertility are not anatomical, uterine fibroids or hydrosalpinx but are ovarian endometriosis or unexplained. The patients must not be diabetic, smoker or alcoholic. After obtaining written informed consent from the patients, they will be examined and demographic and food frequency questionnaires will be completed for all of them. Then, the patients are assigned to intervention and control groups based on stratified random allocation rule in four age groups of under 30, 30-34, 35-37 and 38-40 years old using block size of six. Recommendations to protect the health and nutrition recommendations based on traditional medicine will be educated to the case group and the usual dietary recommendations based on conventional medicine and public health will be educated to the control group. The duration of treatment will be two to three months and the patients will be followed up to obey and use the recommendations. At the end of the study, IVF success will be measured in two groups. The response variables in this study are the outcomes of IVF/ICSI, including: oocytes quality, embryo quality, implantation rate, fertility rate, chemical and clinical pregnancy.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017013032245N2
Registration date:2017-03-08, 1395/12/18
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-03-08, 1395/12/18
Registrant information
Name
Zeinab Alibeigi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 9724
Email address
alibeigibeni.zeinab@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-02-03, 1395/11/15
Expected recruitment end date
2017-07-06, 1396/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the effects of diet based on traditional medicine and usual diet on the results of in vitro fertilization for infertile women
Public title
The impact of diet based on Iranian Traditional Medicine on IVF/ICSI outcomes of infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Iranian race; adult women; age between 20 and 40 years; satisfaction to participate in the study; infertile women with ovarian problems or unexplained infertility causes; lack of anatomical factor infertility; absence of male factor infertility; absence of uterine myoma and hydrosalpinges; not being smoker; not alcohol use; absence of diabetes.
Exclusion criteria: patients’ unwillingness; the patients’ withdrawal from IVF / ICSI.
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Iran University of Medical Sciences
Street address
Tehran
City
Tehran
Postal code
1449614535
Approval date
2017-01-16, 1395/10/27
Ethics committee reference number
IR.IUMS.REC 1395.9221309206
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
clinical pregnancy
Timepoint
3 mounts after intervention
Method of measurement
sonography
Secondary outcomes
1
Description
Oocyt quality
Timepoint
2-3 mounts after intervention
Method of measurement
Oocyt quality evaluation criteria
2
Description
Embryo quality
Timepoint
2-3 mounts after intervention
Method of measurement
Embryo quality evaluation criteria
3
Description
Endometrium tickness
Timepoint
2-3 mounts after intervention
Method of measurement
Sonography
4
Description
Implantation rate
Timepoint
2-3 mounts after intervention
Method of measurement
The number of gestational sac divided by the number of transferred embryos
5
Description
Fertility rate
Timepoint
2-3 mounts after intervention
Method of measurement
the number of oocytes fertilized divided by the number of oocytes inseminated
6
Description
Chemical pregnancy
Timepoint
2-3 mounts after intervention
Method of measurement
Serum Β-hCG meausurment
Intervention groups
1
Description
Intervention group: Diet based on traditional medicine in the intervention group for 2 to 3 months before IVF/ICSI. Intervention group: Diet based on traditional medicine in the intervention group for 2 to 3 months before IVF/ICSI. The recommended foods are those that help gestation, enhance libido, are semen producer, resolve the liver and spleen obstruction, strengthen uterine and main body organs including the brain, liver and heart and they have been used in infertility treatments. These food choices are derived from traditional medicine literature sources and are recommended to be included in patients’ meal plan (breakfast, lunch, dinner and snacks).
Category
Treatment - Other
2
Description
Control group: The usual daily diet in the control group for 2 to 3 months before IVF/ICSI.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord Infertility Center of Hazrat Zahra
Full name of responsible person
Maryam Nemati, Gynecologist and infertility specialist
Street address
Infertility Center of Hazrat Zahra, Next to the Imam Hassan mosque, West Saadi Street, Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute for Islamic and Complementary Medicine (RICM)
Full name of responsible person
Fataneh Hashem Dabaghian
Street address
9, Pirnia Allay, Lalezar Street, Jomhuri Street
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Islamic and Complementary Medicine (RICM)
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Ali Javad Musavi
Street address
Iran University of Medical Sciences, Besides Milad Tower, Hemmat Highway, Tehran
City
Tehran
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 Iran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Zeinab Alibeigi Beni
Position
PhD Student of Traditional Medicine
Other areas of specialty/work
Street address
School of Traditional Medicine, Behest Street, Vahdat Islami Street, Tehran