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| Name | Class |
|---|---|
| Ain Shams University | OTHER |
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effect of vitamin D oral supplementation in poly csytic ovarian women resistant to clomiphene citrate
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pcos resistant to cc plus vit d | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Age: 18-40 years 2- Polycystic ovarian syndrome diagnosis made according to ESHRE/ASRM criteria.
Exclusion Criteria:
Causes of infertility other than PCOS.
Causes of anovulation other than PCOS.
Patients with hyperprolactinemia
Patients with thyroid dysfunction.
Current or in last six months use of vit D treatment.](streamdown:incomplete-link)
in child bearing age
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| rana nasr | Contact | 01274901443 | roona_015@yahoo.com | |
| alhassan khedr | Contact | 01006193797 | alhassankhedr@med.asu.edu.eg |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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a single arm clinical trail
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| Clomid | Drug | CLOMID is adrug used for ovulation induction |
|
| 36 hour of taking HCG |
| D009750 |
| Nutritional and Metabolic Diseases |
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | 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 |