A Phase 3 interventional study of Vitamin D with calcium and clomiphene citrate and Placebo Oral Tablet with calcium and clomiphene citrate in Ovulation Induction, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to female participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-01-11.
Sponsored by Ain Shams University · Phase 3, Interventional, and Treatment
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
Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
93 women who will receive clomiphene citrate for induction of ovulation with vitamin D and calcium supplement
Drug: Vitamin D with calcium and clomiphene citrate
93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement
Drug: Placebo Oral Tablet with calcium and clomiphene citrate
Drug pages: Vitamin D · Calcium · Clomiphene
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 .
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
Rate of ovulation
* 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
Time frame: till cycle day 21 if not reaching more than 18 mm
Number of growing follicles.
to monitor induction
Time frame: 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
Time frame: in cycle day 14 and 21.
Pregnancy rates
both clinical and biochemical
Time frame: 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.
Time frame: for 3 months
Started Jul 2017 (actual). Primary completion is estimated for Mar 2018, 8 months after the start.
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This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Vitamin D · Calcium · Clomiphene