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

Ovulation Induction Clinical Trial

Official title:

Effect of Adding Vitamin D Supplement to Clomiphene Citrate for Induction of Ovulation in Overweight Women With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03396380
• Other study ID #: ain shams maternity hospital
• Status: Recruiting
• Phase: Phase 3
• First received: December 16, 2017
• Last updated: January 9, 2018
• Start date: July 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: January 2018
• Source: Ain Shams University
• Contact: Radwa R Ali
• Phone: 01283492979
• Email: radwaebed[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: May 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Ovulation Induction
• Polycystic Ovary Syndrome

Intervention

Drug:
• Vitamin D with calcium and clomiphene citrate
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. 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 .
• Placebo Oral Tablet with calcium and clomiphene citrate
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. 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

Locations

Country	Name	City	State
Egypt	AinShams university maternity hospital	Cairo	Abbassya

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	till cycle day 21 if not reaching more than 18 mm
Secondary	Number of growing follicles.	to monitor induction	till cycle day 21 if not reaching more than 18 mm
Secondary	Evaluation of the endometrial thickness	could be impaired with antiestrogenic effect of clomiphen citrate	in cycle day 14 and 21.
Secondary	Pregnancy rates	both clinical and biochemical	pregnancy test 1 week after missed menses
Secondary	Adverse effects	hot flashes, headache, nausea, vomiting, breast tenderness, blurred vision, abdominal distention and pain and ovarian enlargement or hyperstimulation.	for 3 months