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Clomiphene Citrate Plus uFSH Versus Aromatase Inhibitor Plus uFSH in Clomiphene Resistant Infertile PCOS Women

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. Identifier: NCT01793038
Recruitment Status : Unknown
Verified March 2013 by Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center.
Recruitment status was:  Recruiting
First Posted : February 15, 2013
Last Update Posted : March 6, 2013
Information provided by (Responsible Party):
Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center

Brief Summary:
Polycystic ovarian syndrome (PCOS) is a condition characterized by infertility, infrequent periods and amenorrhea or irregular bleeding plus anovulatory infertility. Clomid is the standard first drug of treatment for ovulation induction. Ovulation and conception will occur in approximately 75 and 30 percent of cases respectively. Cases not ovulating in response to doses of clomid up to 150 mg/day are known as clomid resistant PCOS.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Infertility Drug: Aromatase inhibitor (litrezole) plus uFSH arm Drug: clomiphene citrate-uFSH arm Not Applicable

Detailed Description:
To test whether CC co- treatment with chronic low dose HP uFSH versus lirizole plus chronic low dose HP uFSH in CC resistant PCOS will yield comparable 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clomiphene Citrate Plus HPuFSH Versus Letrozole Plus HPuFSH in Clomid Resistant Infertile PCOS Women
Study Start Date : March 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Active Comparator: CC-plus uFSH
clomiphene citrate 50 mg tablets twice/day for cycle days 3-7 plus daily IM injection of 37.5 IU HP uFSH for days 3-12
Drug: clomiphene citrate-uFSH arm
clomiphene citrate 50 mg tablets twice /day for 5 days plus 37.5 IU uFSH IM injections daily for 10 days

Experimental: Aromataze inhibitor plus uFSH
Aromataze inhibitor (litrezole )2.5 mg twice daily for cycle days 3-7 plus daily IM injection of uFSH 37.5 IU for cycle days 3-12
Drug: Aromatase inhibitor (litrezole) plus uFSH arm
literozole tablets 5 mg /day for days 3-7 plus intramuscular injections of uFSH 37.5 IU/day for days 3-12

Primary Outcome Measures :
  1. ovulation rate [ Time Frame: 30 days ]
    percentage of ovulatory cycles per started and per completed cycles

Secondary Outcome Measures :
  1. endometrial thickness [ Time Frame: 4 weeks ]
    endmetrial thickness at time of ovulation triggering

  2. ongoing cycle pregnancy rate [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01793038

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Contact: mohamad E GHanem, MD 00201223366955

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Mansoura Integrated fertility center Recruiting
Mansoura, Dekahlia, Egypt
Contact: Mohamad E Ghanem, MD    00201223366955   
Principal Investigator: Mohamad E Ghanem, MD         
Sponsors and Collaborators
Mansoura Integrated Fertility Center

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Responsible Party: Mohamad Elsaid Ghanem, Dr, Mansoura Integrated Fertility Center Identifier: NCT01793038    
Other Study ID Numbers: Mific-3
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: March 6, 2013
Last Verified: March 2013
Keywords provided by Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center:
clomiphene citrate resistant PCOS
Aromatase inhibitors
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Aromatase Inhibitors
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents