Polycystic Ovary Syndrome
Conditions
Keywords
PCOS, Clomiphene resistance, ovulation induction, low dose uFSH, uFSH step-up protocol
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.
Interventions
DRUGStep-up HP u FSH
HP u FSH (Fostimone 75 IU ,IBSA Institut Biochimique SA-CH 6903 Lugano) in doses of 37.5 IU (half ampole) im /day statrted from second day of the cycle for 7 days ,then increased to 75 IU for another 7 days ,then to 112.5 IU (one and half ampoule) untilleading follicle mean diameter reaches 18 mm
DRUGClomiphine citrate plus low dose uFSH
Clomiphene citrate 50 mg tab oral tablets(Clomid 50 mg tablets Global Napi , Egypt) two tablets(100 mg) /day are started from the 2nd day of cycle for 5 days togeteher with 37.5 IU HP uFSH (Fostimone 75 IU IBSA)/day for 8 days and may be extended to 10-12 days until leading follicle diameter reaches 18 mm
Sponsors
Mansoura Integrated Fertility Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* CC resistant PCOS * Infertile * Females * Age 18-38
Exclusion criteria
* Hyperprolactinaemia * Cushing syndrome * Adult onset adrenal hyperplasia * Age \>38 * Other infertility factors in the couple than PCOS: male factor,tubal factor,edometriosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Live birth rate | 6 months | % of of cases that result in live birth \> 20 weeks pregnancy |
| 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 | — |
| 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 |
Countries
Egypt
Outcome results
None listed