Evaluation of the effect of krocina supplement on the follicular oxidative stress and quality of oocyte and embryo in patients with Diminished ovarian reserve (DOR)
Use of Drug Supplements in the Treatment of Patients Decreased Ovarian Reserve as a Supplement to Ovulation Stimulation Hormone Therapy with Less Complications and More Effective Treatments
Design
Clinical trial with control group, with factorial groups, phase 3-2 on 30 patients
Settings and conduct
A treatment group consisted of 15 patients with reduced ovarian reserve (based on inclusion and exclusion criteria) three months after taking one crocin pill per day and a control group consisted of 15 patients with reduced ovarian reserve referred to Taleghani Hospital Infertility Center They enter the ovulation stimulation cycle
Participants/Inclusion and exclusion criteria
Inclusion criteria:
History of uterine bleeding and amenorrhea before 40 years
<FSH 10U / L and AMH <0.5 - 1.1 ng / ml.
Infertility without a specific cause
Exclusion criteria:
POI patients with 25 40 IU / ml
POF patients with a 4-month period of amenorrhea and <FSH40
Chromosomal disease in each pair
Hysterosalpingography, which shows a defective female reproductive system
Genetic disorders such as Turner syndrome
Patients using alkylating agents or radiation therapy
Decreased PTH and aldosterone
Patients with hyper or hypothyroidism
Type I diabetic patients
s
Intervention groups
The first group (treatment) :Women with reduced ovarian reserve treated with Crocina supplementation who enter the ovulation stimulation cycle after three months of supplementation.The second group (control): Women with reduced ovarian reserve who enter the ovulation stimulation cycle
Main outcome variables
Use of drug supplements in the treatment of patients with DOR with fewer complications and more effective treatments
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054872N1
Registration date:2022-06-13, 1401/03/23
Registration timing:registered_while_recruiting
Last update:2022-06-13, 1401/03/23
Update count:0
Registration date
2022-06-13, 1401/03/23
Registrant information
Name
Bahareh Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3522 0008
Email address
karimi.b1367@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of krocina supplement on the follicular oxidative stress and quality of oocyte and embryo in patients with Diminished ovarian reserve (DOR)
Public title
Evaluation of the effect of krocina in patients with Diminished ovarian reserve
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
History of uterine bleeding and amenorrhea before 40 years
FSH <10U/L و AMH<0.5 – 1.1 ng/ml
Infertility without a specific cause
Exclusion criteria:
POI patients with 25 40 IU / ml
POI patients with 25 40 IU / mlPOF patients with a 4-month period of amenorrhea and <FSH40
Chromosomal disease in each pair
Hysterosalpingography, which shows a defective female reproductive system
Genetic disorders such as Turner syndrome
Patients using alkylating agents or radiation therapy
Decreased PTH and aldosterone
Patients with hyper or hypothyroidismType I diabetic patients
Patients with Cushing's disease or Addison's disease
Cases of obesity
History of malignant tumor
Taking antioxidant-related medications in the last 3 months
Use hormone therapy to induce ovulation in the last 2 months
History of taking contraceptives in the last 3 months
Age
To 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Arabi Street, Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985711151
Approval date
2022-05-23, 1401/03/02
Ethics committee reference number
IR.SBMU.MSP.REC.1400.836
Health conditions studied
1
Description of health condition studied
Diminished ovarian reserve
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
patients with Diminished ovarian reserve
Timepoint
Measurement of blood FSH, LH and estradiol levels 3 months after taking the drug
Method of measurement
Evaluation of number and quality of oocytes extracted from ovarian stimulation using stereomicroscope, measurement of superoxide desmutase level in follicular fluid by spectrophotometry using SOD Assay Kit, detection of reactive oxygen species in granulosa cells using flow cytometry On DCFH-DA, assay of NRF2 gene expression as a marker of oxidative stress suppression and GDF9 and BMP15 genes as marker of oocyte maturation in granulosa cells by qRT-PCR
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A treatment group consisting of 15 patients with reduced ovarian reserve (based on inclusion and exclusion criteria) received a dose of one Krocina tablet from Sami Pharmacy with a dose of 15 mg of crocin extract per day for three months and a control group consisted of 15 patients with Decreased ovarian reserve
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleqani Hospital
Full name of responsible person
Dr. Hamid nazarian
Street address
Shahid Chamran Highway, Yemen St., Shahid Arabi St., next to Shahid Beheshti University of Medical Sciences, Ayatollah Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2562
Email
karimi.b1367@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hamid nazarian
Street address
Shahid Chamran Highway, Yemen St. - Shahid Arabi St. next to Ayatollah Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hamid nazarian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Shahid Chamran Highway, Yemen St. - Shahid Arabi St. next to Ayatollah Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
hamid.nazarian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hamid nazarian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Shahid Chamran Highway, Yemen St. - Shahid Arabi St. next to Ayatollah Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
hamid.nazarian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Bahareh karimi
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
hahid Chamran Highway, Yemen St. - Shahid Arabi St. next to Ayatollah Taleghani Hospita
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
karimi.b1367@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available