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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center Identifier:
First received: February 10, 2013
Last updated: March 5, 2013
Last verified: March 2013
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 Intervention
Polycystic Ovary Syndrome Infertility Drug: Aromatase inhibitor (litrezole) plus uFSH arm Drug: clomiphene citrate-uFSH arm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clomiphene Citrate Plus HPuFSH Versus Letrozole Plus HPuFSH in Clomid Resistant Infertile PCOS Women

Resource links provided by NLM:

Further study details as provided by Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center:

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

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

  • ongoing cycle pregnancy rate [ Time Frame: 16 weeks ]

Estimated Enrollment: 160
Study Start Date: March 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01793038

Contact: mohamad E GHanem, MD 00201223366955

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
  More Information

Responsible Party: Mohamad Elsaid Ghanem, Dr, Mansoura Integrated Fertility Center Identifier: NCT01793038     History of Changes
Other Study ID Numbers: Mific-3
Study First Received: February 10, 2013
Last Updated: March 5, 2013

Keywords provided by Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center:
clomiphene citrate resistant PCOS
Aromatase inhibitors

Additional relevant MeSH terms:
Genital Diseases, Female
Fertility Agents, Female
Polycystic Ovary Syndrome
Genital Diseases, Male
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Citric Acid
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
Reproductive Control Agents processed this record on August 16, 2017