Polycystic Ovary
Conditions
Keywords
clomiphene citrate, stair- step, poly cystic ovary
Brief summary
A RCT will be conducted to compare the traditional clomiphene citrate regimens for ovulation induction with the stair-step protocol. Sixty women will be included after obtaining their written informed consent and will be randomized into either of the 2 groups.
Detailed description
This study is a randomized clinical trial (RCT) will be conducted in Ain Shams University maternity hospital at infertility clinic within a period of 6-8 months. All patient are previously diagnosed as PCOs according to the Rotterdam conference of 2003. All patients will be devided according to computer based program into two groups First group: Patients with traditional protocol Traditional protocol: Clomiphene citrate (clomid) (50mg) will be given for 5 days (days 3-7). Transvaginal ultrasound from 9th-20th every other day if ovulation occur the patient will be excluded if no ovulation, we will wait for the next menses and increase the dose to (100mg). if no ovulation occurred increase the dose to (150mg) in the next cycle if no ovulation increase the dose to (200mg) TVUS from 9th-20th ovary other day. If no ovulation we will wait for next cycle and increase the dose to (250mg) and so till 6 cycles . Second group: Patient with stair step protocol Follicular development will be monitored using transvaginal ultrasound at 11-14 day after (50mg) clomiphene for 5 days if there is no response (no follicle \>10mm), so, (100mg) clomiphene will be initiated immediately for 5 days and ultrasound will be repeated 1 week after the first ultrasound. If there is no response, (150mg) clomiphene will be initiated immediately for another 5 days and TV/US will be performed 1 week after the second TV/US .
Interventions
stair-step clomiphene adminstration
Sponsors
Ain Shams Maternity Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 20-35 years. * Body mass index (BMI/m2) 26-35 kg/m2 * Normal hystrosalpingogram (HSG). * Normal Prolactin level. * Normal semen analysis.
Exclusion criteria
* \- They underwent ovarian drilling. * Other factors infertility. * AUTOimmune diseases as thyroid disorders and systemic lupus erythematosus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of the ovulation by transvaginal ultrasound | 20 days | * Follicle suddenly disappears or regresses in size. * Irregular margins. * Intra follicular echos. Follicle suddenly becomes more echogenic. * Free fluid in pouch of douglas. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to achieve ovulation | 20 days | time for ovulation to occur |
| dose of clomiphene to achieve ovulation | 20 days | the total dose of clomiphene used till ovulation |
Countries
Egypt
Contacts
Primary ContactAdel S Salah El-Din, MD
Outcome results
None listed