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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center
ClinicalTrials.gov Identifier:
NCT01212263
First received: September 29, 2010
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
Drug: Step-up HP u FSH
Drug: Clomiphine citrate plus low dose uFSH

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mansoura Integrated Fertility Center:

Primary Outcome Measures:
  • ovulation rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Live birth rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    % 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 174
Study Start Date: January 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01212263

Locations
Egypt
Mansoura Integrated fertility Center
Mansoura, Dekahlia, Egypt
Sponsors and Collaborators
Mansoura Integrated Fertility Center
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mohamad Elsaid Ghanem, Dr, Mansoura Integrated Fertility Center
ClinicalTrials.gov Identifier: NCT01212263     History of Changes
Other Study ID Numbers: MansouraIFC1
Study First Received: September 29, 2010
Last Updated: May 29, 2013
Health Authority: Egypt:Ministry of health

Keywords provided by Mansoura Integrated Fertility Center:
PCOS
Clomiphene resistance
ovulation induction
low dose uFSH
uFSH step-up protocol

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Clomiphene
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on July 26, 2014