The Effect Of Vitamin D Replacement Therapy On Serum Leptin And Follicular Growth Pattern In Women With Resistant Polycystic Ovary

Polycystic Ovary Syndrome Clinical Trial

Official title:

The Effect Of Vitamin D Replacement Therapy On Serum Leptin And Follicular Growth Pattern In Women With Resistant Polycystic Ovarian Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03806036
• Other study ID #: 47
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2, 2018
• Est. completion date: February 2019

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: Ahmed Maged, MD
• Phone: +201005227404
• Email: prof.ahmedmaged[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study included 100 female diagnosed with polycystic ovary syndrome. They were classified into 2 groups: Study group included 50 women will receive 300.000 I.U single dose of Vitamin D intramuscular injection (Memphis company) , and in the next menstrual cycle induction done by clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day . Control group included 50 women will receive only clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day. Serum 25 hydroxy Vitamin D3, Serum Leptin and FSH will be done to all women before and after intervention.

Description:

The study included 100 female diagnosed with polycystic ovary syndrome diagnosed by by presence of 2 out of 3 criteria (according to ESHRE/ASRM in Rotterdam in 2003): oligoovulation and/or an ovulation , excess androgen activity (clinical or biochemical) and polycystic ovaries (by pelvic ultrasound "vaginal route").They were classified into 2 groups: Study group included 50 women will receive 300.000 I.U single dose of Vitamin D intramuscular injection (Memphis company) , and in the next menstrual cycle induction done by clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day . Control group included 50 women will receive only clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day. Serum 25 hydroxy Vitamin D3, Serum Leptin and FSH will be done to all women before and after intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1- BMI: more than 25.0 kg/m2

2- PCO was diagnosed by presence of 2 out of 3 criteria (according to ESHRE/ASRM in Rotterdam in 2003)

1. oligoovulation and/or an ovulation

2. excess androgen activity (clinical or biochemical)

3. polycystic ovaries (by pelvic ultrasound "vaginal route")

3- Anovulatory patient resistant to induction with clomiphene citrate alone

Exclusion Criteria:

-1) BMI: more than 35.0 kg/m2

2) Infertile women due to any factor other than PCO

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Vitamin D
300.000 I.U single dose of VIT D IM injection
• Clomiphene Citrate
100mg daily for 5 days starting from third day of menstruation

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation	appearance of dominant follicle 18 - 22 mm in diameter	14 days after menses