Polycystic Ovarian Syndrome
Conditions
Brief summary
Clomiphene citrate resistant i.e failure to ovulate after 6 cycles of ovulation induction effects 15-40% of patients with PCOS.Two treatment groups will be formed one recieving letrozole alone and another recieving CC and letrozole combined.Mature follicles and endometrial thickness will be checked by transvaginal ultrasound and results will be recorded.
Detailed description
Subfertility is characterized by the inability to achieve conception despite engaging in regular unprotected sexual intercourse for 1-2 years.PCOS exhibits chacteristic traits such as obesity,heightened insulin resistance accompanied by compensatory hyperinsulinemia,oligo/anovulation and subfertility.Clompiphene citrate induces ovarian stimulation.Letrozole ,an aromatase inhibitor emerges as a novel medication with comparable efficacy to CC as a first line treatment for inducing ovulation in cases of anovulation.
Interventions
DRUGClomiphene Citrate and letrozole
clomiphene citrate 100mg once daily along with letrozole 5mg to one group and letrozole 5mg to second group
Sponsors
HITEC-Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
lottery method for selection
Intervention model description
randomization intervention RCT
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* women of 20-40 years with a history of PCOS and resistant to CC
Exclusion criteria
* Premature ovarian insufficiency * Husband has oligo azoospermia * Hypothyroidism * Hyperprolactinemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare the rate of ovulation | 6 months | To compare the rate of ovulation between letrozole alone and letrozole and CC |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORRukhsana Shaheen Afzal, MBBS,FCPS
HITEC-Institute of Medical Sciences
Outcome results
None listed