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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Mansoura Integrated Fertility Center
Sponsor:
Information provided by (Responsible Party):
Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center
ClinicalTrials.gov Identifier:
NCT01793038
First received: February 10, 2013
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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 Mansoura Integrated Fertility Center:

Primary Outcome Measures:
  • ovulation rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    percentage of ovulatory cycles per started and per completed cycles


Secondary Outcome Measures:
  • endometrial thickness [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    endmetrial thickness at time of ovulation triggering

  • ongoing cycle pregnancy rate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

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.

  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
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 ClinicalTrials.gov identifier: NCT01793038

Contacts
Contact: mohamad E GHanem, MD 00201223366955 meghanem87@gmail.com

Locations
Egypt
Mansoura Integrated fertility center Recruiting
Mansoura, Dekahlia, Egypt
Contact: Mohamad E Ghanem, MD    00201223366955    meghanem87@gmail.com   
Principal Investigator: Mohamad E Ghanem, MD         
Sponsors and Collaborators
Mansoura Integrated Fertility Center
  More Information

Publications:
Responsible Party: Mohamad Elsaid Ghanem, Dr, Mansoura Integrated Fertility Center
ClinicalTrials.gov Identifier: NCT01793038     History of Changes
Other Study ID Numbers: Mific-3
Study First Received: February 10, 2013
Last Updated: March 5, 2013
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura Integrated Fertility Center:
PCOS
clomiphene citrate resistant PCOS
Aromatase inhibitors

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Fertility Agents, Female
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Genital Diseases, Male
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Aromatase Inhibitors
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Sequestering 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

ClinicalTrials.gov processed this record on September 22, 2014