Imbalanced relation between the apoptosis and the proliferation of ovarian cells and follicular atresia is one of the main problems in the patients with polycystic ovarian syndrome (PCOS). So by using antiapoptotic antioxidants such as N-acetyl cysteine (NAC) we can prevent follicular atresia and find the way to overcome disease signs.
20 PCOS patients (age: 25-35) candidate for IVF cycle will participate randomly in the present study. There will be two groups: (1) NAC groups: patients will take NAC (600mg) three times per day for six weeks. (2): placebo group: patients will take placebo three times per day for six weeks. The collaboration in the present study will be between department of anatomical sciences and IVF center of Shahid Akbarabadi Hospital.
Granulosa cells of follicular fluid of patients in IVF cycle will be sorted by using filtering method. In the next step the expression of apoptotic and antiapoptotic genes will be studied by Real Time PCR technique.
Patient in our study will be chosen according to Rotterdam criteria. The exclusion criteria are Hyperprolactinemia and thyroid disease.
Intervention in the present study is administration of N-acetyl cysteine.
Main outcome variables include the expression of mRNA of apoptotic (caspase-3 and Bax) and anti-apoptotic (XIAP and Bcl-2) genes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041227353N1
Registration date:2016-06-11, 1395/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-11, 1395/03/22
Registrant information
Name
Reza Shirazi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4821
Email address
shirazi.r@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of N-acetyl Cysteine (NAC) on apoptotic factors in granulosa cells of women with polycystic ovarian syndrome
Public title
Reducing complications and treatment of patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria for patients: Diagnosis of PCOS according to the Rotterdam criteria, aged between 25 and 35 years, the lack of Oral contraceptive pill (OCP) and hormone analogues Apart from progesterone , The use of assisted reproductive medicine at the same dose in all cases, the absence of other systemic diseases known, the first IVF cycle in patients.
exclusion criteria for patients : Hyperprolactinemia, thyroid disease, congenital adrenal hyperplasia, testosterone-secreting tumors, Cushing, endometriosis, FSH above 10 IU / L on the third day after menstrual bleeding,
Use of drugs that affect the metabolism of carbohydrates, using an analog of the hormone progesterone than three months before entering the study and severe kidney and liver diseases.
Age
From 25 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences