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

Primary Purpose

Polycystic Ovary Syndrome, Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aromatase inhibitor (litrezole) plus uFSH arm
clomiphene citrate-uFSH arm
Sponsored by
Mansoura Integrated Fertility Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, clomiphene citrate resistant PCOS, Aromatase inhibitors

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mansoura Integrated fertility centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CC-plus uFSH

Aromataze inhibitor plus uFSH

Arm Description

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

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

Outcomes

Primary Outcome Measures

ovulation rate
percentage of ovulatory cycles per started and per completed cycles

Secondary Outcome Measures

endometrial thickness
endmetrial thickness at time of ovulation triggering
ongoing cycle pregnancy rate

Full Information

First Posted
February 10, 2013
Last Updated
March 5, 2013
Sponsor
Mansoura Integrated Fertility Center
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1. Study Identification

Unique Protocol Identification Number
NCT01793038
Brief Title
Clomiphene Citrate Plus uFSH Versus Aromatase Inhibitor Plus uFSH in Clomiphene Resistant Infertile PCOS Women
Official Title
Clomiphene Citrate Plus HPuFSH Versus Letrozole Plus HPuFSH in Clomid Resistant Infertile PCOS Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura Integrated Fertility Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Infertility
Keywords
PCOS, clomiphene citrate resistant PCOS, Aromatase inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CC-plus uFSH
Arm Type
Active Comparator
Arm Description
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
Arm Title
Aromataze inhibitor plus uFSH
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Aromatase inhibitor (litrezole) plus uFSH arm
Intervention Description
literozole tablets 5 mg /day for days 3-7 plus intramuscular injections of uFSH 37.5 IU/day for days 3-12
Intervention Type
Drug
Intervention Name(s)
clomiphene citrate-uFSH arm
Intervention Description
clomiphene citrate 50 mg tablets twice /day for 5 days plus 37.5 IU uFSH IM injections daily for 10 days
Primary Outcome Measure Information:
Title
ovulation rate
Description
percentage of ovulatory cycles per started and per completed cycles
Time Frame
30 days
Secondary Outcome Measure Information:
Title
endometrial thickness
Description
endmetrial thickness at time of ovulation triggering
Time Frame
4 weeks
Title
ongoing cycle pregnancy rate
Time Frame
16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamad E GHanem, MD
Phone
00201223366955
Email
meghanem87@gmail.com
Facility Information:
Facility Name
Mansoura Integrated fertility center
City
Mansoura
State/Province
Dekahlia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamad E Ghanem, MD
Phone
00201223366955
Email
meghanem87@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohamad E Ghanem, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21457973
Citation
Abdellah MS. Reproductive outcome after letrozole versus laparoscopic ovarian drilling for clomiphene-resistant polycystic ovary syndrome. Int J Gynaecol Obstet. 2011 Jun;113(3):218-21. doi: 10.1016/j.ijgo.2010.11.026. Epub 2011 Apr 1.
Results Reference
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PubMed Identifier
19809318
Citation
Palomba S, Falbo A, Zullo F. Management strategies for ovulation induction in women with polycystic ovary syndrome and known clomifene citrate resistance. Curr Opin Obstet Gynecol. 2009 Dec;21(6):465-73. doi: 10.1097/GCO.0b013e328332d188.
Results Reference
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Clomiphene Citrate Plus uFSH Versus Aromatase Inhibitor Plus uFSH in Clomiphene Resistant Infertile PCOS Women

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