Clomiphene Allergy, Polycystic Ovary Syndrome, Vitamin D Deficiency
Conditions
Keywords
Poly cystic ovary syndrome, Vitamin D
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.
Interventions
DRUGVitamin D
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.
DRUGClomid
CLOMID is adrug used for ovulation induction
Sponsors
Ain Shams University
rana alaaeldin aly ibrahim nasr
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
a single arm clinical trail
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 18-40 years 2- Polycystic ovarian syndrome diagnosis made according to ESHRE/ASRM criteria. 1. Polycystic ovaries (either 12 or more follicles or increased ovarian volume \[\> 10 cm3 2. Oligo-ovulation or anovulation 3. Clinical and/or biochemical signs of hyperandrogenism (Azziz, 2006). 3- PCOS infertile women resistant to CC for 3 cycles. clomiphene citrate resistance means failure to ovulate with 3 months use of clomid at 150 mg/day for 5 days
Exclusion criteria
* Causes of infertility other than PCOS. 1. Male factor.(normal semen analysis) 2. Other factors e.g. endometriosis 3. Tubal factor. (normal hysterosalpingography) 4. Premature ovarian failure: Day 3 FSH \> 14 mlu/ml or antimullerian hormone \<1 ng/ml. 5. Normal ultrasound except for criteria of PCO * Causes of anovulation other than PCOS. * Patients with hyperprolactinemia * Patients with thyroid dysfunction. * Current or in last six months use of vit D treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of the ovulated follicles | 36 hours of taking HCG injection | Number of ovulated follicles by trans vaginal ultra sound signs of ovulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pregancy rate | 2 days after delayed menses | Pregnancy test positive by quantititave see beta HCG level |
| Evaluation of the endometrial thickness | 36 hour of taking HCG | Measure the endometrium thickness by transvaginal ultrasound |
Contacts
Primary Contactrana nasr
Backup Contactalhassan khedr
Outcome results
None listed