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

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
FSH 225IU and hMG 225IU
FSH 150IU and hMG 150IU
Letrozole 5mg and hMG 150IU
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring poor responders

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Istanbul University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Combined 450

Combined 300

Letrozole and hMG

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Clinical pregnancy rate

Secondary Outcome Measures

Number of oocytes retrieved
Number of transferable embryos
Biochemical pregnancy rate

Full Information

First Posted
November 14, 2014
Last Updated
January 7, 2016
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT02293668
Brief Title
Outcome of Three Controlled Ovarian Hyperstimulation Protocols in Poor Responding Infertility Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
poor responders

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Combined 450
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Combined 300
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Letrozole and hMG
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
FSH 225IU and hMG 225IU
Intervention Type
Drug
Intervention Name(s)
FSH 150IU and hMG 150IU
Intervention Type
Drug
Intervention Name(s)
Letrozole 5mg and hMG 150IU
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of oocytes retrieved
Time Frame
4 weeks
Title
Number of transferable embryos
Time Frame
4 weeks
Title
Biochemical pregnancy rate
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Istanbul University School of Medicine
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
21505041
Citation
Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.
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Outcome of Three Controlled Ovarian Hyperstimulation Protocols in Poor Responding Infertility Patients

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