Main objectives:
Determining the effect of Ferula assa-foetida on the quantity and quality of eggs in infertile women with PCO
Design
A phase 3, double-blind, randomized, controlled clinical trial on 72 patients, using four-way alternating blocks for randomization.
Settings and conduct
This research will be a randomized, double-blind clinical trial with two intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include:
1. Women aged 18 to 40 years
2. History of primary or secondary infertility
3. Diagnosis of polycystic ovary syndrome based on the opinion of a specialist doctor
4. No known mental illness or any illness that affects the fertility process.
5. Normal fallopian tubes.
6. The absence of infertility in the spouse, according to the doctor's approval.
Exclusion criteria include:
1. Women who are discouraged from continuing to participate in the study for any reason.
2. Causing any complications during treatment with Ovla Mom capsules that are in conflict with pregnancy.
Intervention groups
The intervention includes the daily consumption of two Ovalamam capsules, each containing 500 mg of oleogum resin from the plant Ferula assa-foetida, and the control group will be prescribed two capsules daily, each capsule will be in the form of capsules similar and of the same weight as the Ovalamam capsules and will contain bread powder, which will be encapsulated at the Clinical Trial Research Center of Traditional Medicine at Shahed University.
Main outcome variables
If this herbal product achieves a positive effect on the symptoms of polycystic ovary syndrome and infertility, by providing its results to women's and mothers' health officials, it will improve the health of women and subsequently the entire family, as well as reduce consumer costs.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241127063875N1
Registration date:2025-01-02, 1403/10/13
Registration timing:prospective
Last update:2025-01-02, 1403/10/13
Update count:0
Registration date
2025-01-02, 1403/10/13
Registrant information
Name
Sajedeh Bahjati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
sajedeh.bahjati@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-02-03, 1403/11/15
Expected recruitment end date
2026-02-04, 1404/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The Effect Of Ferula assa-foetida On The Quantity And Quality Of Eggs In Infertile Women With polycystic ovaries
Public title
Investigating The Effect Of Ferula assa-foetida On The Quantity And Quality Of Eggs In Infertile Women With polycystic ovaries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18 to 40 years2. History of primary or secondary infertility3. Diagnosis of polycystic ovary syndrome based on the opinion of a specialist doctor4. No known mental illness or any illness that affects the fertility process.5. Normal fallopian tubes.6. The absence of infertility in the spouse, according to the doctor's approval.
History of primary or secondary infertility
Diagnosis of polycystic ovary syndrome based on the opinion of a specialist doctor
No known mental illness or any illness that affects the fertility process
Normal fallopian tubes
The absence of infertility in the spouse, according to the doctor's approval
Exclusion criteria:
The presence of a known mental illness or any illness that may affect the reproductive process.
Infertility due to abnormal fallopian tubes
Infertility in the spouse
The presence of any infertility that has a cause other than polycystic ovary syndrome.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be a double-blind randomized clinical trial with two intervention and control groups.
Sampling will be done after completing the informed consent form using the available method and the samples will be selected based on purpose and will be randomly assigned to two groups of intervention (A) and control (B) using quadruple permutation blocks and through lottery, then the intervention will be started with medication for 16 weeks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Coding of drug and placebo packages will be done in the School of Pharmacy of Shahed University of Medical Sciences and by the research consultant, and until the end of data analysis, the researcher and the patient (samples) will be unaware of the method of drug allocation, therefore, this study will be double-blind.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Nursing and Midwifery, Tehran University of Medical Sciences
Street address
Towhid Square, Dr. Mirkhani Street (East Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2025-03-05, 1403/12/15
Ethics committee reference number
IR.TUMS.FNM.REC.1403.153
Health conditions studied
1
Description of health condition studied
Egg quantity and quality in women with polycystic ovary syndrome
Egg quantity, which refers to the number of follicles.
Timepoint
16 weeks
Method of measurement
Ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention will begin with medication for 16 weeks. The intervention will include the daily intake of two Ovulam capsules, each capsule containing 500 mg of oleogum resin from the plant Ferula assa-foetida.
Category
Treatment - Drugs
2
Description
Control group: The control group will also be prescribed two capsules daily, each capsule being the same size and weight as the Ovalamam capsule and containing bread powder, which will be encapsulated at the Traditional Medicine Clinical Trial Research Center at Shahed University.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina infertility center
Full name of responsible person
Mam Infertility Center
Street address
Ibn Sina Infertility and Recurrent Abortion Treatment Center, Tehran Branch, Shariati Street, Corner of Yakhchal Street, No. 97
City
Tehran
Province
Tehran
Postal code
1983969412
Phone
+98 21 23519
Email
Sajedeh.bahjati@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ramin kordi
Street address
Towhid Square, Dr. Mirkhani Street (East Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Sajedeh.bahjati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sajedeh bahjati
Position
Master's degree student in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Towhid Square, Dr. Mirkhani Street (East Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Sajedeh.bahjati@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sajedeh Bahjati
Position
Master's degree student in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Towhid Square, Dr. Mirkhani Street (East Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Sajedeh.bahjati@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sajedeh Bahjati
Position
Master's degree student in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Tehran, Nosrat, Mirkhani St
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
Sajedeh.bahjati@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Because this research is in the form of a thesis, all of the above-mentioned items in this research will be shared in the meetings of the Research Council of the Faculty's Reproductive Health Department and the final defense meeting for the council members.
When the data will become available and for how long
When defending the proposal and final defense of the thesis
To whom data/document is available
Research team members, final report reviewers, and stakeholders (pharmacist and gynecologist)
Under which criteria data/document could be used
In addition to the aforementioned data, possible side effects of the drug can also be provided for the purpose of drug manufacturing.
From where data/document is obtainable
Supervisor Dr. Mehrnaz Garanmayeh Email:
geranmay@tums.ac.ir
What processes are involved for a request to access data/document
After the request, if the supervisor and the research team deem it appropriate, the information will be sent according to the contract between them.