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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Vitamin D
* Drug: Clomiphene Citrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D group<br>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 | Drug: Vitamin D<br>* 300.000 I.U single dose of VIT D IM injection<br>Drug: Clomiphene Citrate<br>* 100mg daily for 5 days starting from third day of menstruation<br>* Other names: Clomid;|
| Placebo Comparator: Control group<br>50 women will receive clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day | Drug: Clomiphene Citrate<br>* 100mg daily for 5 days starting from third day of menstruation<br>* Other names: Clomid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation | appearance of dominant follicle 18 - 22 mm in diameter | 14 days after menses |