Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate

Study Overview
=================
Brief Summary
-----------------
effect of vitamin D oral supplementation in poly csytic ovarian women resistant to clomiphene citrate

Detailed Description
-----------------
Polycystic ovarian syndrome is the most common endocrine disorder . It is associated with chronic anovulation and infertility. The diagnosis is made by clinical and ancillary investigations revealing the presence of irregular menstrual cycles, an ovulation , Hyperandrgenemia , and the presence of polycystic ovaries (ovarian morphology as the presence of 12 or more follicles measuring 2-9 mm in diameter and an increased ovarian volume >10 cm 3) ovulation can be induced with clomiphene citrate (CC), However,  20%-25% of anovulatory women with PCOS do not respond to CC and are considered to be clomiphene-resistant( clomiphene citrate resistance means failure to ovulate with 3 months use of clomid at 150 mg/day for 5 days ) Vitamin D may serve as a key in preventing and attenuating the insulin resistance. Vitamin D plays a physiologic role in reproduction including ovarian follicular development and luteinisation, follicle-stimulating hormone sensitivity and progesterone production in human granulosa cells. It also affects glucose homeostasis . In this trial 100 women with PCO disease that diagnosed by ROTTERDAM CRITERIA (must have any TWO of This findings: Hyperandrogenism, Oligomenorrhea, Polycystic ovaries). Who are taking clomiphene citrate for induction of ovulation and resistant to it, which means failure to ovulate with 3 months of usage of clomid at 150 mg/day for 5 days. They will recieve vitamin D (ossofortin®, Eva Pharma) orally 10000 IU twice weekly for other three months period with clomiphene citrate orally 150 mg/day for 5 days. Number and size of the growing follicles will be monitored before and after taking vitamin D by trans-vaginal ultrasound at day11-14 of the cycle till day 21 to detect effect of vitamin D in ovulation rate.

Official Title
-----------------
Effect of Vitamin D Oral Supplementation in Poly Cystic Ovarian Women Resistant to Clomiphene Citrate

Conditions
-----------------
Vitamin D Deficiency, Clomiphene Allergy, Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Vitamin D
* Drug: Clomid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-40 years 2- Polycystic ovarian syndrome diagnosis made according to ESHRE/ASRM criteria. Polycystic ovaries (either 12 or more follicles or increased ovarian volume [> 10 cm3 Oligo-ovulation or anovulation Clinical and/or biochemical signs of hyperandrogenism (Azziz, 2006). 3- PCOS infertile women resistant to CC for 3 cycles. clomiphene citrate resistance means failure to ovulate with 3 months use of clomid at 150 mg/day for 5 days Exclusion Criteria: Causes of infertility other than PCOS. Male factor.(normal semen analysis) Other factors e.g. endometriosis Tubal factor. (normal hysterosalpingography) Premature ovarian failure: Day 3 FSH > 14 mlu/ml or antimullerian hormone <1 ng/ml. Normal ultrasound except for criteria of PCO Causes of anovulation other than PCOS. Patients with hyperprolactinemia Patients with thyroid dysfunction. Current or in last six months use of vit D treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: a single arm clinical trail
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pcos resistant to cc plus vit d<br>100 patients who are PCOS and resist CC will receive Vitamin D 10000 IU orally plus 150mg clomid orally for 3 months number and size of growing follicles will be monitored | Drug: Vitamin D<br>* Adding vitamin D to PCOS patients who are resistant to clomiphene regime for induction will or not improve the Clinical pregnancy rate and will or not increase chances of ovulation and pregnancy.<br>Drug: Clomid<br>* CLOMID is adrug used for ovulation induction<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of the ovulated follicles | Number of ovulated follicles by trans vaginal ultra sound signs of ovulation | 36 hours of taking HCG injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregancy rate | Pregnancy test positive by quantititave see beta HCG level | 2 days after delayed menses | 
| Evaluation of the endometrial thickness | Measure the endometrium thickness by transvaginal ultrasound | 36 hour of taking HCG | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Poly cystic ovary syndrome