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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | 1st subgroup will be tested and treated with vitamin D together with Clomiphene Citrate for induction of ovulation |
|
| control | Active Comparator | 2nd subgroup will be treated with Clomophene Citrate only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | 6000 IU of vitamin D3 |
|
|
| 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 |
| 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 |
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Inclusion 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.
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed M kotb, MD | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Ain Shams University | Cairo | Cairo Governorate | Egypt |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002996 | Clomiphene |
| D010062 | Ovulation Induction |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Ovulatory Agent | Drug | only Clomophine Citrate |
|
|
| 6 months |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D013267 |
| Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |