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Spots Global Cancer Trial Database for Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate

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Trial Identification

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

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

Study ID: NCT04916925

Interventions

Vitamin D
Clomid

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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