Polycystic Ovary Syndrome
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGVitamin D
300.000 I.U single dose of VIT D IM injection
DRUGClomiphene Citrate
100mg daily for 5 days starting from third day of menstruation
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovulation | 14 days after menses | appearance of dominant follicle 18 - 22 mm in diameter |
Countries
Egypt
Contacts
Primary ContactAhmed Maged, MD
Backup ContactWesam Deeb, MD
Outcome results
None listed