Clomiphene Citrate (CC) Co-treatment With HP Urinary FSH vs HP Urinary FSH in CC-resistant PCOS
- Conditions
- Polycystic Ovary Syndrome
- Interventions
- Drug: Clomiphine citrate plus low dose uFSHDrug: Step-up HP u FSH
- Registration Number
- NCT01212263
- Lead Sponsor
- Mansoura Integrated Fertility Center
- Brief Summary
To test whether adding small doses of HP urinary FSH to standard regimen of clomiphene citrate in clomiphene resistant PCOS well yield better results in terms of better ovulation rate,lower follicle number, less consumption of HP urinary FSH,lower treatment cost , better pregnancy rate, lower multiple pregnancy rates compared with the exclusive use of HP urinary FSH in these cases.
- Detailed Description
To test whether CC co- treatment with chronic low dose HP uFSH vs chronic low dose HP uFSH in CC resistant PCOS will yield better results in terms of ,ovulation rate, lower follicle number,lower HP uFSH dose ,better outcome in terms of pregnancy rates, better cost-effectiveness ratio, lower multiple pregnancy rates,lower cycle cancellation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 174
- CC resistant PCOS
- Infertile
- Females
- Age 18-38
- Hyperprolactinaemia
- Cushing syndrome
- Adult onset adrenal hyperplasia
- Age >38
- Other infertility factors in the couple than PCOS: male factor,tubal factor,edometriosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clomiphene Citrate plus HP uFSH Clomiphine citrate plus low dose uFSH Starting from the 2nd day of the cycle Clomiphene Citrate( CC)50 mg tablets are given in 100 mg daily dose for 5 days together with an low dose HP uFSH (half ampoule: 37.5 IU) given im daily for 8-10 days. Step-up HP uFSH Step-up HP u FSH HP uFSH started in doses of half ampole (37.5 )IU daily from the 2nd day of cycle for 7 days ,then dose is stepped-up to one ampoule ( 75 IU) for 7 days then the one and a half amps (112.5) IU /day until follicular diameter reaches 18 mm mean diameter
- Primary Outcome Measures
Name Time Method ovulation rate 6 months IF CC Co-treatment with low dose step-up HP urinary(u)FSH results in similar or higher ovulation rate compared with step-up low dose HP uFSH
- Secondary Outcome Measures
Name Time Method Live birth rate 6 months % of of cases that result in live birth \> 20 weeks pregnancy
number of follicles sized 16 mm or more mean diameter in both ovaries at the time of hCG 3 months To test if CC-co treatment with low dose HP uFSH results in lower number of follicles 16 mm mean diameter or more at time of triggerring ovulation compared with low dose HP uFSH
Endometrial thickness 3 months Measuring endometrial thickness in mm in both study arms at the time of ovulation trigerring to see if there is difference
serum Estradiol(E2) 3 months serum level of E2 is measured in both groups at the time of ovulation triggerring to test for differences
incidence of multiple pregnancy 3 months To test if CC-co treatment with low dose HP uFSH results in lower or higher incidence of multiple pregnancies compared with low dose HP uFSH
costs per cycle 3 months costs of drugs used to induce ovulation in each arm of the study in Egyptian pounds The cost of HP uFSH per cycle was calculated by multiplying the cost of a single IU with the mean number of FSH IU used per cycle. Add to this the cost of clomiphene citrate in the relevant arm
cost effectiveness ratio 6 months The cost-effectiveness ratio is calculated multiplying the cost per cycle by the total number of cycles performed in each arm then dividing the result for the number of clinical pregnancies obtained in the arm during the trial.
clinical and biochemical predictors of response to treatment 6 weeks
Trial Locations
- Locations (1)
Mansoura Integrated fertility Center
🇪🇬Mansoura, Dekahlia, Egypt