Comparison of Treatment Modalities in Poor Responders Undergoing IVF

January 7, 2016 updated by: Ercan Bastu
The accurate identification and efficient management of poor responders remains one of the most enigmatic challenges in assisted reproductive technology (ART). The investigators study will compare the letrozole/antagonist protocol to the hMG/antagonist protocol in women who poor responders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

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 Locations

  • Turkey
      • Istanbul, Turkey, 34093
        • Department of Obstetrics and Gynecology, Istanbul University School of Medicine

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 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients will be considered eligible if they are poor ovarian responders according to the Bologna criteria (Ferraretti et al., 2011).

  • Two out of three of the following criteria are essential in order to classify a patient as poor ovarian responder:

    • advanced maternal age (≥40 years) or any other risk factor for poor ovarian response;
    • a poor ovarian response (≤3 oocytes with a conventional stimulation protocol); or
    • an abnormal ovarian reserve test (antral follicle count, <7 follicles or anti-Mullerian hormone, <1.1 ng/ml).

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: human menopausal gonadotropin (hMG)
hMG at a dose of 300 IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.
Drug: human menopausal gonadotropin (hMG)
Active Comparator: Letrozole
Letrozole (Femara; Novartis, East Hanover, NJ) at a dose of 5 mg/day will be initiated on the second or third day of spontaneous menstruation and continued for 5 days. Again on the second or third day of spontaneous menstruation, 150 IU of hMG will be started until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of hCG as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.
Drug: Letrozole
Other Names:
  • Femara

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: up to 2 weeks
The primary outcome measure will be the ongoing pregnancy rate (>12 weeks' gestation) per started cycle.
up to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancellation Rate
Time Frame: up to one month
One of the secondary outcome measures will be cancellation rate.
up to one month
Number of oocytes retrieved
Time Frame: up to one month
One of the secondary outcome measures will be number of oocytes retrieved.
up to one month
Number of transferable embryos
Time Frame: up to one month
One of the secondary outcome measures will be number of transferable embryos.
up to one month
Implantation rate
Time Frame: up to 2 weeks
One of the secondary outcome measures will be implantation rates.
up to 2 weeks
Clinical pregnancy rate
Time Frame: up to 2 weeks
One of the secondary outcome measures will be clinical pregnancy rates.
up to 2 weeks

Collaborators and Investigators

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

Sponsor

Ercan Bastu

Investigators

  • Principal Investigator: Harika Yumru, M.D., Istanbul University School of Medicine
  • Study Chair: Hasan F Buyru, M.D. Prof., Istanbul University School of Medicine
  • Study Director: Ercan Bastu, M.D., Istanbul University School of Medicine

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

June 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

June 6, 2014

First Posted (Estimate)

June 9, 2014

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10017 (Other Identifier: CTEP)

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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