Effect of Vitamin D Supplement in Induction of Ovulation in Overweight Women With Polycystic Ovary Syndrome

Ain Shams University

Status and phase: Unknown; Phase 3

Conditions: Ovulation Induction

Treatments: Drug: Vitamin D with calcium and clomiphene citrate; Drug: Placebo Oral Tablet with calcium and clomiphene citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT03396380

ain shams maternity hospital

Details and patient eligibility

About

The aim of this work is to evaluate the effect of vitamin D supplementation in overweight infertile women with PCOs undergoing induction of ovulation.

Full 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

Enrollment: 186 estimated patients

Sex: Female

Ages: 25 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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186 participants in 2 patient groups, including a placebo group

vitamin D

Active Comparator group

Description:

93 women who will receive clomiphene citrate for induction of ovulation with vitamin D and calcium supplement

Treatment:

Drug: Vitamin D with calcium and clomiphene citrate

placebo

Placebo Comparator group

Description:

93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement

Treatment:

Drug: Placebo Oral Tablet with calcium and clomiphene citrate