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

March 5, 2013 updated by: Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center

Clomiphene Citrate Plus HPuFSH Versus Letrozole Plus HPuFSH in Clomid Resistant Infertile PCOS Women

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dekahlia
      • Mansoura, Dekahlia, Egypt
        • Recruiting
        • Mansoura Integrated Fertility Center
        • Contact:
        • Principal Investigator:
          • Mohamad E Ghanem, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ovulation rate
Time Frame: 30 days
percentage of ovulatory cycles per started and per completed cycles
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endometrial thickness
Time Frame: 4 weeks
endmetrial thickness at time of ovulation triggering
4 weeks
ongoing cycle pregnancy rate
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura Integrated Fertility Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ANTICIPATED)

June 1, 2014

Study Completion (ANTICIPATED)

September 1, 2014

Study Registration Dates

First Submitted

February 10, 2013

First Submitted That Met QC Criteria

February 13, 2013

First Posted (ESTIMATE)

February 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 5, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mific-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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