Determining the effect of royal jelly on ovum and embryo quality in infertile women with low ovarian reserve treated with IVF
Design
Clinical trial with control group, with parallel groups, double-blind, randomized
Settings and conduct
The study population is infertile women with low ovarian reserve treated by IVF in Hazrat Zahra Infertility Center in Shahrekord in 1400
Participants/Inclusion and exclusion criteria
Infertile women with low ovarian reserve under the age of 40 who are candidates for IVF without any underlying disease, history of abdominal and pelvic surgery, male infertility, hysterosalpingography and abnormal prolactin
Intervention groups
In this study, infertile women with low ovarian reserve are candidates for IVF after baseline tests. The intervention group will receive 1 g of Royal Jelly daily for 2 months before the IVF cycle and the control group will receive a placebo
Main outcome variables
The rate of chemical and clinical pregnancies in the study groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211024052858N1
Registration date:2021-10-26, 1400/08/04
Registration timing:prospective
Last update:2021-10-26, 1400/08/04
Update count:0
Registration date
2021-10-26, 1400/08/04
Registrant information
Name
Afrooz Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 5505
Email address
afroozjfr@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of royal jelly compared with placebo on ovum and embryo quality in infertile women with low ovarian reserve treated by IVF
Public title
The effect of royal jelly on ovum and embryo quality in infertile women with low ovarian reserve treated by IVF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with low ovarian reserve under the age of 40 who are candidates for IVF
Evaluation of sperm test and normal hysterosalpingogram
Absence of any underlying disease, history of abdominal and pelvic surgery, male infertility, hysterosalpingography and abnormal prolactin
Patient consent to participate in the study and collaborate in the follow-up course
Exclusion criteria:
The patient refuses to perform IVF
The presence of any underlying disease, history of abdominal and pelvic surgery, male infertility, hysterosalpingography and abnormal prolactin and sensitivity to royal jelly cause the patient to be removed from the examination process
Age
To 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization to two groups of 55 people using a Randomizer software
Blinding (investigator's opinion)
Double blinded
Blinding description
Royal Jelly and placebo capsules will be prepared in the form of capsules and packaging exactly the same as the letters A and B, and the participant and the researcher do not know what capsule A or B contains
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
Vice Chancellor for Research and Technology, Building No. 2, University Headquarters, Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2021-09-28, 1400/07/06
Ethics committee reference number
IR.SKUMS.REC.1400.147
Health conditions studied
1
Description of health condition studied
Infertility with low ovarian reserve
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
The effect of royal jelly on ovum and embryo quality in infertile women with low ovarian reserve treated with IVF
Timepoint
3-5 days after fertilization
Method of measurement
Inner cell mass grading system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Royal Jelly Capsules 1 g daily for 2 months before IVF-ICSI cycle
Category
Treatment - Drugs
2
Description
Control group: Placebo capsules in the same color, shape and size as the intervention capsule
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord Hazrat Zahra Infertility Center
Full name of responsible person
Maryam Nemati Dehkordi
Street address
West Saadi St., next to Imam Hassan Mosque
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816866659
Phone
+98 38 3222 8740
Email
nemati.m@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Vice Chancellor for Research, Building No. 2, University Headquarters, Ayatollah Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
Sadeghi@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
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
Shahre-kord University of Medical Sciences
Full name of responsible person
Afrooz Jafari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 8575
Email
Afroozjfr@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Maryam Nemati Dehkordi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 5505
Email
nemati.m@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Afrooz Jafari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 5505
Email
Afroozjfr@yahoo.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
Information is kept confidential
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcome can be shared
When the data will become available and for how long
After publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Using data to complete studies
From where data/document is obtainable
Shahrekord University of Medical Sciences, Dr. Maryam Nemati
What processes are involved for a request to access data/document
By examining the researcher's request and providing sufficient documentation of his research and the reason for using the data can be provided