Ovulation Induction
Conditions
Brief summary
The aim of this work is to evaluate the effect of vitamin D supplementation in overweight infertile women with PCOs undergoing induction of ovulation.
Detailed description
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
Interventions
DRUGVitamin D with calcium and clomiphene citrate
1. Vitamin D ( ossofortin®, EVA PHARMA) 10000 IU twice weekly and calcium (calciprex®, Marcyrl Pharmaceutical Industries ) 1250 mg twice daily which provide elemental calcium 500 mg/tablet for one month before induction of ovulation and both will be continued during the 3 induction cycles in the same regimen. 2. Induction of ovulation by clomiphene citrate (Clomid®, Aventis) 50 mg tablet twice daily 12 hours apart (total dose 100 mg daily) starting from the third day of menstrual cycle and for five days .
DRUGPlacebo Oral Tablet with calcium and clomiphene citrate
1. The placebo tablet twice weekly and calcium (calciprex®, Marcyrl Pharmaceutical Industries ) 1250 mg twice daily which provide elemental calcium 500 mg/tablet for one month before induction of ovulation and both will be continued during the 3 induction cycles in the same regimen. 2. induction of ovulation by clomiphene citrate (Clomid®, Aventis) 50 mg tablet twice daily 12 hours apart (total dose 100 mg daily)starting from the 3rd day of menstrual cycle and for five days
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* polycystic ovarian syndrome diagnosis made according to ESHRE/ASRM criteria. * infertility is the cause for seeking treatment. * overweight females with BMI more than 25 but less than 30.
Exclusion criteria
* causes of infertility other than PCOS. * causes of anovulation other than PCOS. * current or in last six months use of hormonal treatment. * contraindication to any drug used in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of ovulation | till cycle day 21 if not reaching more than 18 mm | * Transvaginal ultrasound will be done to detect signs of ovulation: corpus luteum, fluid in cul-de-sac, collapse of the follicle size. * Serum progesterone will be measured in the mid luteal day of the cycle, where: Level 19 nmol/L indicates Ovulation. Level \<5 nmol/L suggests Ovulation did not occur |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of growing follicles. | till cycle day 21 if not reaching more than 18 mm | to monitor induction |
| Evaluation of the endometrial thickness | in cycle day 14 and 21. | could be impaired with antiestrogenic effect of clomiphen citrate |
| Pregnancy rates | pregnancy test 1 week after missed menses | both clinical and biochemical |
| Adverse effects | for 3 months | hot flashes, headache, nausea, vomiting, breast tenderness, blurred vision, abdominal distention and pain and ovarian enlargement or hyperstimulation. |
Countries
Egypt
Contacts
Primary ContactRadwa R Ali
Outcome results
None listed