Correction of Vitamin D Deficiency and Its Effect on Ovulation Induction in Women With PCOS (VIDEO): A Feasibility RCT

Study Overview
=================
Brief Summary
-----------------
Recently, a special emphasis has recently been directed to the potential role of vitamin D and some regulatory peptides (e.g. adipokines and follistatin) and their associated metabolic roles and genetic factors in the development of PCOS and its related co-morbidities. The aim of this study was to assess the feasibility of conducting a pragmatic RCT assessing the effectiveness of adopting a protocol of screening for and correcting Vitamin D deficiency in women with PCOS seeking fertility treatment in a low/middle income care (LMIC) setting

Detailed Description
-----------------
Research question: In PCOS patients, is there any effect of vitamin D testing and correction on ovulation induction in women with PCOS? Research hypothesis: There is effect of testing and correcting vitamin D status as regard ovulation in patients with PCOS

Official Title
-----------------
Correction of Vitamin D Deficiency and Its Effect on Ovulation Induction in Women With PCOS (VIDEO): A Feasibility RCT

Conditions
-----------------
PCOS

Intervention / Treatment
-----------------
* Drug: Vitamin D
* Drug: Ovulatory Agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria Exclusion Criteria: 1- PCOS patients not in child bearing age; less than 18 years or more than 45 years. 2- Patients with congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia and virilizing ovarian or adrenal tumors. 3- PCOS patients with any other medical illness. 4- PCOS patients already on vitamin D supplements.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>1st subgroup will be tested and treated with vitamin D together with Clomiphene Citrate for induction of ovulation | Drug: Vitamin D<br>* 6000 IU of vitamin D3<br>* Other names: Vidrop®, Medical Union Pharmaceuticals, Egypt;Drug: Ovulatory Agent<br>* only Clomophine Citrate<br>* Other names: Clomiphene Citrate for induction of ovulation;|
| Active Comparator: control<br>2nd subgroup will be treated with Clomophene Citrate only | Drug: Ovulatory Agent<br>* only Clomophine Citrate<br>* Other names: Clomiphene Citrate for induction of ovulation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative clomiphene citrate-induced ovulation rates | Ultrasound Folliculometry was performed every other day starting on the 10th day of the induction cycle. Until, at least, one follicle reached 18mm in diameter | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumlative clinical pregnancy rate | detection of fetal heart activity detected by transvaginal ultrasound | 6 months | 
| median ovulating dose of clomiphene citrate | Dose required | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, vitamin D