Protocol summary

Summary
(1) Aims: The purpose of this study was to investigate the effect of traditional medicine diet on follicular growth and the incidence of pregnancy in women with ovulation induction. (2) Design: this is a semi-experimental study, participants will be divided into 2 groups (intervention group with Training of Diet Program based on Traditional Medicine and Control group without any training ). In this intervention, women trained for ovulation induction based on traditional Iranian medicine that is derived from Iranian traditional medicine sources are taught to coexist with dietary ovulation induction medications and the effect of diet on follicular growth And the occurrence of pregnancy. In this program, the usual regimen is based on the traditional medicine guidelines, with respect to the limb temperament and the proper general temperament for improving ovulation and fertility, in a way that does not contradict modern medicine. The diet is based on traditional Iranian medicine by a traditional medicine specialist and includes the following points: Fat, Macaroni, Macaroni, Lasagna, Pizza, Noodles, Cold Fruits and Vegetables, Mushrooms, Fries, Raw Vegetables, Barley, Fish, Beef, Veal, Sausages, Sausages, Hamburgers, Tuna Fish, Dishes Coffee, Cacao, Confectionery, Candy and Chocolate, Pickles, Chives, Salted, and Seasoned, Canned, Tomato Paste, Sauce, Dairy (Yogurt, Dough, Ice Cream, Whey, Cheese Spices and peppers (except turmeric and salt), drinks (such as industrial juices, soft drinks, delicatessen, bergamot tea). You may prefer lamb or chicken and chicken, soup bread, rice cooked, apples, grapes, olives, dates, figs, bananas, mangoes, cooked vegetables, carrot juice, apple juice, raisins, currants, egg yolks Honey, Olive Oil, Walnuts, and Pistachios Eat more meals but fewer. It is advisable not to eat food for half an hour before the next two hours. The legumes are soaked for 12 hours and then cooked with a little salt or preferably cooked in half of their equivalent of rice. If you are obliged to use dairy products, you can make a cup of hot milk plus a little sugar or honey or grape juice (or slightly) a day Use pasteurized cheese. (3) How to do: In this semi-experimental study, 60 infertile women with ovarian syndrome are participated. Individuals are divided into two groups of control and intervention, the intervention group receives the face-to-face training and pamphlet diet plan, and observes the diet during 1 to 3 cycles of ovulation stimulation, and the control group has the usual diet. The dietary regimen is monitored by the feed recall questionnaire and analyzed with the software. (4) Inclusion criteria: The lack of physical illness and chronic ؛ no history of mental problems ؛ ovarian factor infertility ؛ cycles of ovulation induction is 1 to 3 ؛ FSH level over IU / L 1 and less than 15. Exclusion criteria: Do not diet for more than 24 consecutive hours ؛ Lack of patient to the ultrasound report (5) Interventions: The effect of a traditional medicine program on follicular growth and the incidence of pregnancy in women with ovulation induction. The food program is a recipes derived from traditional medicine resources by the professor of traditional medicine counseling. (6) Main outcome variables: The main outcome is follicle growth in terms of follicle count and diameter, and measurement of pregnancy by BhCG ​​assay and sonography and observation of fetal heart rate.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016081629388N1
Registration date: 2017-10-16, 1396/07/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-16, 1396/07/24
Registrant information
Name
nasrin jamehbozorg
Name of organization / entity
nivercity of medical science of iran
Country
Iran (Islamic Republic of)
Phone
+98 918 908 6798
Email address
jamehbozorg.n@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences.
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-09-06, 1396/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Impact of Diet Program based on Traditional Medicine on Ovulation and Fertility Rate in Woman with Induction of Ovulation
Public title
Impact of Diet Program based on Traditional Medicine on Ovulation and Fertility Rate in Woman with Induction of Ovulation
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: The lack of physical illness and chronic ؛ no history of mental problems ؛ ovarian factor infertility ؛ cycles of ovulation induction is 1 to 3 ؛ FSH level over IU / L 1 and less than 15. Exclusion criteria: Do not diet for more than 24 consecutive hours ؛ Lack of patient to the ultrasound report
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
University of Medical Sciences Iran-Ethics Committee
Street address
Hemat highway
City
Tehran
Postal code
Approval date
2016-12-11, 1395/09/21
Ethics committee reference number
IR.IUMS.REC.1395.9311373009

Health conditions studied

1

Description of health condition studied
infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation

Primary outcomes

1

Description
Growth of follicles
Timepoint
Before the fifteenth day of the menstrual cycle and 3 cycles after intervention
Method of measurement
Sonography

2

Description
pregnancy
Timepoint
After the first delay in menstruation (a period of ovulation stimulation is performed in three menstrual cycles, a three-cycle maximum test is performed.)
Method of measurement
Levels of serum BHCG/Imaging FHR In Ultrasound

Secondary outcomes

empty

Intervention groups

1

Description
In this intervention, women trained for ovulation induction based on traditional Iranian medicine that is derived from Iranian traditional medicine sources are taught to coexist with dietary ovulation induction medications and the effect of diet on follicular growth And the occurrence of pregnancy. In this program, the usual regimen is based on the traditional medicine guidelines, with respect to the limb temperament and the proper general temperament for improving ovulation and fertility, in a way that does not contradict modern medicine. The diet is based on traditional Iranian medicine by a traditional medicine specialist and includes the following points: Fat, Macaroni, Macaroni, Lasagna, Pizza, Noodles, Cold Fruits and Vegetables, Mushrooms, Fries, Raw Vegetables, Barley, Fish, Beef, Veal, Sausages, Sausages, Hamburgers, Tuna Fish, Dishes Coffee, Cacao, Confectionery, Candy and Chocolate, Pickles, Chives, Salted, and Seasoned, Canned, Tomato Paste, Sauce, Dairy (Yogurt, Dough, Ice Cream, Whey, Cheese Spices and peppers (except turmeric and salt), drinks (such as industrial juices, soft drinks, delicatessen, bergamot tea). You may prefer lamb or chicken and chicken, soup bread, rice cooked, apples, grapes, olives, dates, figs, bananas, mangoes, cooked vegetables, carrot juice, apple juice, raisins, currants, egg yolks Honey, Olive Oil, Walnuts, and Pistachios Eat more meals but fewer. It is advisable not to eat food for half an hour before the next two hours. The legumes are soaked for 12 hours and then cooked with a little salt or preferably cooked in half of their equivalent of rice. If you are obliged to use dairy products, you can make a cup of hot milk plus a little sugar or honey or grape juice (or slightly) a day Use pasteurized cheese
Category
Lifestyle

2

Description
In the control group, the diet program is not taught.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbar Abadi Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences.
Full name of responsible person
Seyed Ali Javad Musavi
Street address
Iran University of Medical Sciences, Next to 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
Iran University of Medical Sciences.
Proportion provided by this source
100
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 Sciences, School of nursing and midwifery
Full name of responsible person
Nasrin Jamebozorg
Position
MSc student of Midwifery
Other areas of specialty/work
Street address
No. 467- Tohyd Alley- Takhty Street- Hamedan
City
Hamedan
Postal code
Phone
+98 81 3262 0985
Fax
Email
nasring54@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of nursing and midwifery
Full name of responsible person
Leila Neisani Samani
Position
Msc of Midwifery؛Academic Degree Instructor
Other areas of specialty/work
Street address
School of nursing and midwifery,Yasemi Rashid street, Valiasr street. Tehran.
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
neisani89@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences, School of nursing and midwifery
Full name of responsible person
Nasrin Jamebozorg
Position
MSc student of Midwifery
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
nasring54@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...