The effects of Resveratrol on expression of main ovarian angiogenesis genes (VEGF & HIF-1) & androgene aromatization gene (CYP19) in granolosa cells of PCOS patients and their IVF outcomes.
This is a triple-blind RCT study. The ART (ICSI) candidate PCOS patients, firstly confirm their syndrome based on Rotterdam Criterion. The patients that full fill the inclusion criteria will sign the consent informed form. 40 patients randomly assigned equally to two groups for Resveratrol (Intervention) & Placebo (Control) groups. All patients take the Resveratrol/placebo 1 gr/day for 40 days from the beginning of their menstruation cycle till oocyte retrieval in OR room. Expression of the CYP19, VEGF & HIF-1 will quantify by the real-time PCR (SYBR green). Finally, The sexual hormones & Fertility outcomes of the patients (like; oocytes quality, number of oocytes, fertilization rate, cleavage rate, embryos quality, number of embryos & chemical pregnancy rate) will be assessed and compromised in two groups.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016030126860N1
Registration date:2016-03-15, 1394/12/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-15, 1394/12/25
Registrant information
Name
Mojdeh Bahramrezaie
Name of organization / entity
Tehran University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 4438 2693
Email address
m-bahramrezaie@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental- Tehran University of Medical Sciences.
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Resveratrol on expression of main ovarian angiogenesis genes (VEGF & HIF-1) & androgene aromatization gene (CYP19) in granolosa cells of PCOS patients and their IVF outcomes.
Public title
The effects of Resveratrol on PCOS.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Infertility with documented PCOS & Hyperandrogenism; 18-40 Y/O; Candidate for IVF Cycle; If have male factor; it must mild to moderate form, not non-obstructive azospermia; If have other female factor; only cervical & tubal factors are acceptable. Exclusion Criteria: FSH>10; Severe endometriosis (Stage III or IV); Coshing Syndrome; Hyperprolactinemia; Thyroid diseases; Ovarian Tumors; Severe male factor like non-Obstructive Azospermia; Steroids & OCP taking History in past 3 months; SLE (Systemic Lupus Erythematosus) & autoimmune diseases; Systemic diseases like Metabolic Syndrome, Hyperlipidemia, Diabetes & cardiovascular diseases; Diseases due to malnutrition & obesity with unknown cause.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences ethical committee
Street address
Tehran, Poursina St.
City
Tehran
Postal code
Approval date
2016-01-19, 1394/10/29
Ethics committee reference number
IR.TUMS.REC.1394.1690
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome (PCOS)
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
CYP19 Expression
Timepoint
After follicle retrieval (Approximately 40 days after treatment)
Method of measurement
Real-time relative quantification
2
Description
VEGF Expression
Timepoint
After follicle retrieval (Approximately 40 days after treatment)
Method of measurement
Real-time relative quantification
3
Description
HIF-1 Expression
Timepoint
After follicle retrieval (Approximately 40 days after treatment)