Outcome of Three Controlled Ovarian Hyperstimulation Protocols in Poor Responding Infertility Patients

January 7, 2016 updated by: Ercan Bastu, Istanbul University
There are different controlled ovarian hyperstimulation protocols utilized in infertility patients. In this study, our aim is to specifically compare three protocols in poor responding infertility patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

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
        • 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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Combined 450
Recombinant FSH 225IU/day and human menopausal gonadotropin (hMG) 225IU/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 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.
Drug: FSH 225IU and hMG 225IU
ACTIVE_COMPARATOR: Combined 300
Recombinant FSH 150IU/day and human menopausal gonadotropin (hMG) 150IU/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 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.
Drug: FSH 150IU and hMG 150IU
ACTIVE_COMPARATOR: Letrozole and hMG
Letrozole (Femara; Novartis, East Hanover, NJ) at a dose of 5 mg/day and human menopausal gonadotropin (hMG) 150IU/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: Letrozole 5mg and hMG 150IU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of oocytes retrieved
Time Frame: 4 weeks
4 weeks
Number of transferable embryos
Time Frame: 4 weeks
4 weeks
Biochemical pregnancy rate
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

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

Sponsor

Istanbul University

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

November 1, 2014

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (ESTIMATE)

November 18, 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

  • 1001 (Registro Nacional Estudios Clinicos (RNEC))

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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