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The aim of this work is to evaluate the effect of vitamin D supplementation in overweight infertile women with PCOs undergoing induction of ovulation.
The study will include overweight infertile women with PCOS seeking fertility who will receive induction of ovulation by clomiphene citrate will be recruited and randomized into two groups:
Group A (study group): 93 women who will receive clomiphene citrate for induction of ovulation with vitamin D and calcium supplement
Group B (control group): 93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D | Active Comparator | 93 women who will receive clomiphene citrate for induction of ovulation with vitamin D and calcium supplement |
|
| placebo | Placebo Comparator | 93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D with calcium and clomiphene citrate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of ovulation |
Level 19 nmol/L indicates Ovulation. Level <5 nmol/L suggests Ovulation did not occur | till cycle day 21 if not reaching more than 18 mm |
| Measure | Description | Time Frame |
|---|---|---|
| Number of growing follicles. | to monitor induction | till cycle day 21 if not reaching more than 18 mm |
| Evaluation of the endometrial thickness | could be impaired with antiestrogenic effect of clomiphen citrate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radwa R Ali | Contact | 01283492979 | 02002 | radwaebed@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AinShams university maternity hospital | Recruiting | Cairo | Abbassya | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32363556 | Derived | Rasheedy R, Sammour H, Elkholy A, Salim Y. The efficacy of vitamin D combined with clomiphene citrate in ovulation induction in overweight women with polycystic ovary syndrome: a double blind, randomized clinical trial. Endocrine. 2020 Aug;69(2):393-401. doi: 10.1007/s12020-020-02315-3. Epub 2020 May 3. |
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|
| Placebo Oral Tablet with calcium and clomiphene citrate | Drug |
|
|
| in cycle day 14 and 21. |
| Pregnancy rates | both clinical and biochemical | pregnancy test 1 week after missed menses |
| Adverse effects | hot flashes, headache, nausea, vomiting, breast tenderness, blurred vision, abdominal distention and pain and ovarian enlargement or hyperstimulation. | for 3 months |
| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002118 | Calcium |
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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