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Clomiphene Citrate (CC) Co-treatment With HP Urinary FSH vs HP Urinary FSH in CC-resistant PCOS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01212263
First Posted: September 30, 2010
Last Update Posted: May 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center
September 29, 2010
September 30, 2010
May 30, 2013
January 2010
September 2012   (Final data collection date for primary outcome measure)
ovulation rate [ Time Frame: 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
Same as current
Complete list of historical versions of study NCT01212263 on ClinicalTrials.gov Archive Site
  • Live birth rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 weeks ]
  • cycle pregnancy rate (CPR) [ Time Frame: 6 months ]
    The number of pregnanacies that take place per 100 treatment cycles (%)(CPR)
  • number of follicles sized 16 mm or more mean diameter in both ovaries at the time of hCG [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Not Provided
Not Provided
 
Clomiphene Citrate (CC) Co-treatment With HP Urinary FSH vs HP Urinary FSH in CC-resistant PCOS
Clomiphene Citrate Co-treatment With Low Dose HP Urinary FSH vs. HP Urinary FSH Step-up Protocol for Clomiphene-citrate Resistant PCOS Anovulatory Infertility: Randomized Controlled Trial
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Polycystic Ovary Syndrome
  • Drug: Step-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
  • Drug: Clomiphine 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
  • Experimental: Clomiphene Citrate plus HP 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.
    Intervention: Drug: Clomiphine citrate plus low dose uFSH
  • Active Comparator: Step-up HP uFSH
    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
    Intervention: Drug: Step-up HP u FSH

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
September 2012
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 38 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
 
NCT01212263
MansouraIFC1
No
Not Provided
Not Provided
Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center
Mansoura Integrated Fertility Center
Not Provided
Study Chair: Mohamad E Ghanem, MD Mansoura Integrated Fertility Center
Study Director: Mohammad A Emam, MD Mansoura Integrated Fertility Center
Principal Investigator: Mohamad E Ghanem, MD Mansoura Integrated Fertility Center
Mansoura Integrated Fertility Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP