الفهرس 
Polycystic ovary syndrome (PCOS)Only 14 pages are availabe for public view
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Abstract
Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder that affects women in the child-bearing period.Anovulation is one of the most prominent features of such a syndrome, and is a common cause of female infertility.
PCOS affects as many as 10% of reproductive-age women when using the NIH criteriafor diagnosis, and up to 18% of reproductive-age women are diagnosed with PCOS as per the Rotterdam criteria .
PCOS is now considered as a female subtype of the metabolic syndrome and its potential health consequences are a lifelong issue.
Clinical features of themetabolic syndrome (obesity, diabetes mellitus, or hypertriglyceridemia)are commonly observed in NAFLD.Moreover, primary NAFLD is now considered the hepatic manifestation of metabolic syndrome.
VDD is increasingly diagnosed in Western patients and is commonly found in NAFLD populations .
Several studies and a recent meta-analysis have demonstrated a high prevalence of vitamin D deficiency among women with PCOS.
Numerous observational studies investigated the association of 25(OH)VitD status with metabolic and endocrine parameters of PCOS . In general, PCOS women had lower 25(OH)VitD levels compared to healthy controls.
Given the pleiotropic effects of vitamin D ranging from hormonal to immunologic to cellular differentiation, it is quite possible vitamin D
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replacement in VDD may produce significant biochemical and histologic benefit, although more data from appropriately powered prospective randomized placebo-controlled trials are needed.
The traditional treatment of PCOS isaimed at the clinical features and dependson the manifestations that are most bothersometo the patient.A notable number of interventional studies explored the therapeutic implications of vitamin D in the metabolic and reproductive aspects ofPCOS.vitamin D treatment could improve follicle development and menstrual cyclicity.
The current study is one of the few double blind RCT to assess the effect of VD supplementation on clinical pregnancy rates and ovulation rate in PCOS patients undergoing ovarian induction by letrozole. In this study, effect of vitamin D supplementation was assessed on success ofletrozole induction of ovulation and clinicalpregnancy.
Methodology of the study
This study is a randomized controlled study conducted at Benha University on 100 subfertile PCOS women with vitamin D deficiency or insufficiency after application of Inclusion and exclusion criteria.
The study protocol was approved by Ethical committee of faculty of medicine Benha University. Any woman eligible to participate was informed about the trial . Those approved to participate gave informed written consent.
The study population was a consecutive series of sub fertile women (primary or secondary infertility) aged between 20 and 35 years, with PCOS (diagnosed by using ESHRE/ASRM criteria) Rotterdam’s
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criteriawith Vitamin D deficiency or insufficiency (defined as serum 25-OH-vitamin D levels < 20 ng/ml or 20 - < 30 ng/ml, respectively).
We excluded Women with thyroid disorders, hyper prolactinemia or other causes of hyper androgenism (e.g. Cushing syndrome), previous ovarian surgery,Women with a body mass index (BMI)35Kg/m2and Couples who have other associated causes of infertility (e.g. male factor infertilityor long duration of infertility (> 5 years) .
Allocation to either one of the two groups was in a 1:1ratio.
Administration of Vitamin D or placebo started on the second day of the last menstrual period .For Women of group I who received vitamin D supplementation,weekly dose of 50000 units of Vitamin D supplementation Breva (VordexPHARM) in addition to metformin treatment(Glucophage® 1000 mg XR [Merck Serono, Darmstadt, Germany]) once per day with breakfast meal for 3 months before commencing induction of ovulation.Serum vit D re assay was done.
Induction Of Ovulation With Letrozole
After 3 months of metformin ± vitamin D supplementation, all included women received ovulation induction by letrozole 2.5 mg[Femara®, Novartis, Egypt] twice per day, from day 2 through day 6 of menses or withdrawal bleeding twice per day.Serial transvaginal ultrasound was performed to monitor the number and size of developing follicles to time of human chorionic gonadotropin (hCG) administration(Choriomon® IBSA) 5000 IU ampoule, single dose10,000 IU intramuscular which was given when the leadingfollicle reaches 18–20 mm in diameter to induce ovulation. All participants were advised about timed intercourse duringthe treatment cycles.
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The primary outcome was Positive ongoing clinical pregnancy, defined as presence of viable intrauterine pregnancy after 12 weeks of gestation.
The secondary outcomes were
Principal Secondary Outcome:
Positive ovulation, which is deemed to have occurred if the follicle reaches a mean diameter of 18–25 mm and subsequently changed in size, shape, or sonographic density.
Other secondary outcomes:
No. of mature dominant follicle(s),Positive biochemical pregnancy, Positive clinical pregnancy, No. of viable gestational sacs
Miscarriage rate.
Treatment continued until pregnancy or for up to three induction cycles.
This study showed that:
Following vitamin D3 supplementation, the incidence of ongoing pregnancy showed statistically significant increase in vitamin D group compared to placebo group(39.1% and 18.4%% respectively) P = 0.025.
In our study ,VD group showed an increase in both the clinical and biochemical pregnancy rates compared to placebo (39.1% and 45.7% versus 22.4% and 32.7 respectively), although this did not reach statistical significance (p = 0.078 and 0.19 respectively).
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We have found alsostatistically significant increase inovulation after the induction cycles in vit D group compared to the placebo group (p = 0.001, 0.001 and 0.045) through three consecutive induction cycles
In our study,No. of mature dominant follicle(s)differed significantly between groups. As only(10.9% ) PCOS women failed to ovulate for three induction cycles in the intervention groupversus( 42.9%)women in the placepo group .
Vitamin D group
Patients in intervention group had been subdivided according serum vit D re assay into two sub groups.
Insufficient or deficient vitamin D level despite treatment (sub group A) and normal vitamin D level after supplementation ( subgroup B).
They differed statically in vitamin D re assay results were mean( 21.17ng/ml) and (34.34ng/ml ) in sub group A and subgroup B respectively p=<0.001*.
we found a significant increase in sub group A compared to sub group B in rates of on going ,clinical and bio chemical pregnancy.
Ovulation rates also differed significantly between two groups
There was no statistic difference between two groups according No of gestational sacs and miscarriage rate.