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

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Cairo University (CU)

Status and phase

Unknown
Phase 4

Conditions

Polycystic Ovary Syndrome

Treatments

Drug: Clomiphene Citrate
Drug: Vitamin D

Study type

Interventional

Funder types

Other

Identifiers

NCT03806036
47

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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)

  • oligoovulation and/or an ovulation
  • excess androgen activity (clinical or biochemical)
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups, including a placebo group

Vitamin D group
Active Comparator group
Description:
50 women will receive 300.000 I.U single dose of VIT D IM 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
Treatment:
Drug: Vitamin D
Drug: Clomiphene Citrate
Control group
Placebo Comparator group
Description:
50 women will receive clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day
Treatment:
Drug: Clomiphene Citrate

Trial contacts and locations

1

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Central trial contact

Wesam Deeb, MD; Ahmed Maged, MD

Data sourced from clinicaltrials.gov

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