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Effect of a Higher Than Maximum 450IU Gonadotropin Dose in an In-vitro Fertilization Cycle

Primary Purpose

Subfertility

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
menotropins for injection
urofollitropin for injection
Sponsored by
Clinique Ovo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subfertility focused on measuring IVF, dose comparison of gonadotrophins, poor responder to ovarian stimulation

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • RESIDENT OF CANADA
  • Premenopausal
  • Age 40 years or less at the time of enrollment
  • At risk of a poor ovarian response defined as: either <5 oocytes or <8 follicles in a previous cycle, FSH > 10 IU/L, AMH < 1 pg/ml , antral follicle count less or equal to 8 or previous IVF cancellation
  • Primary infertility or secondary
  • Not previously undertaken a cycle that was included in this study

Exclusion Criteria:

  • Simultaneous participation in another clinical trial
  • Body mass index (BMI) > 38 kg/m2
  • Early follicular phase (day 2-4) serum FSH level > 20 mIU/ml
  • Any contraindication to being pregnant and carrying a pregnancy to term
  • Contraindication for the use of Estrace® , Suprefact®, Menopur®, Bravelle®, hCG, and luteal phase support medication
  • Any ovarian or abdominal abnormality that may interfere with adequate transvaginal ultrasound evaluation
  • Administration of any investigational drugs within three months prior to study enrollment
  • Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study
  • Positive results of screening of either partner for HIV antibodies, Hepatitis B (other than for surface antibodies present after vaccination) or Hepatitis C
  • Unwillingness to give written informed consent

Sites / Locations

  • Ovo Fertilité

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

450 IU daily dose of gonadotrophin

600 IU daily dose of gonadotrophin

Arm Description

Outcomes

Primary Outcome Measures

Number of metaphase II oocytes retrieved during the course of one treatment cycle

Secondary Outcome Measures

Number of follicles recruited per patient during stimulation
Fertilization rate per patient (number of normally fertilized (with 2 pronuclei) oocytes/number of mature oocytes collected)
Embryo cleavage rate per patient (number of divided normally fertilized oocytes/number of normally fertilized oocytes)
Number of embryos available per patient
Number of supernumerary embryos available for cryopreservation per patient
Implantation rate
Biochemical pregnancy rate
Clinical pregnancy rate
Rate of multiple gestation
Ongoing pregnancy rate
Live birth rate
rate of occurrence of ovarian hyperstimulation syndrome (OHSS)

Full Information

First Posted
September 2, 2009
Last Updated
March 12, 2014
Sponsor
Clinique Ovo
Collaborators
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00971152
Brief Title
Effect of a Higher Than Maximum 450IU Gonadotropin Dose in an In-vitro Fertilization Cycle
Official Title
Effect of a Higher Than Maximum 450IU Gonadotropin Dose on Patient Outcomes in an In-Vitro Fertilization Setting: a Randomized Controlled Non-infertility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinique Ovo
Collaborators
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This goal of this study is to evaluate the outcomes from in vitro fertilization cycles where a 450 IU daily dose of gonadotropins is administered compared to those where a 600 IU daily dose is administered for women who are at risk of a poor ovarian response in order to determine if one dose or the other results in improved cycle outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfertility
Keywords
IVF, dose comparison of gonadotrophins, poor responder to ovarian stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
450 IU daily dose of gonadotrophin
Arm Type
Active Comparator
Arm Title
600 IU daily dose of gonadotrophin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
menotropins for injection
Other Intervention Name(s)
Menopur
Intervention Description
comparison of different dosages
Intervention Type
Drug
Intervention Name(s)
urofollitropin for injection
Other Intervention Name(s)
Bravelle
Intervention Description
comparison of different dosages
Primary Outcome Measure Information:
Title
Number of metaphase II oocytes retrieved during the course of one treatment cycle
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of follicles recruited per patient during stimulation
Time Frame
2 years
Title
Fertilization rate per patient (number of normally fertilized (with 2 pronuclei) oocytes/number of mature oocytes collected)
Time Frame
2 years
Title
Embryo cleavage rate per patient (number of divided normally fertilized oocytes/number of normally fertilized oocytes)
Time Frame
2 years
Title
Number of embryos available per patient
Time Frame
2 years
Title
Number of supernumerary embryos available for cryopreservation per patient
Time Frame
2 years
Title
Implantation rate
Time Frame
2 years
Title
Biochemical pregnancy rate
Time Frame
2 years
Title
Clinical pregnancy rate
Time Frame
2 years
Title
Rate of multiple gestation
Time Frame
2 years
Title
Ongoing pregnancy rate
Time Frame
2 years
Title
Live birth rate
Time Frame
2 years
Title
rate of occurrence of ovarian hyperstimulation syndrome (OHSS)
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: RESIDENT OF CANADA Premenopausal Age 40 years or less at the time of enrollment At risk of a poor ovarian response defined as: either <5 oocytes or <8 follicles in a previous cycle, FSH > 10 IU/L, AMH < 1 pg/ml , antral follicle count less or equal to 8 or previous IVF cancellation Primary infertility or secondary Not previously undertaken a cycle that was included in this study Exclusion Criteria: Simultaneous participation in another clinical trial Body mass index (BMI) > 38 kg/m2 Early follicular phase (day 2-4) serum FSH level > 20 mIU/ml Any contraindication to being pregnant and carrying a pregnancy to term Contraindication for the use of Estrace® , Suprefact®, Menopur®, Bravelle®, hCG, and luteal phase support medication Any ovarian or abdominal abnormality that may interfere with adequate transvaginal ultrasound evaluation Administration of any investigational drugs within three months prior to study enrollment Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study Positive results of screening of either partner for HIV antibodies, Hepatitis B (other than for surface antibodies present after vaccination) or Hepatitis C Unwillingness to give written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise Lapensee, MD
Organizational Affiliation
ovo fertilité
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacques Kadoch, MD
Organizational Affiliation
OVO Fertilité and OVO R & D
Official's Role
Study Director
Facility Information:
Facility Name
Ovo Fertilité
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4P 2S4
Country
Canada

12. IPD Sharing Statement

Citations:
Citation
Srouji SS, Missmer SA, Ginsburg ES (2004) Impact of increasing gonadotropins > 450 IU on cycle outcome. Brigham and Women's Hospital, Boston, MA. Fertil Steril 82 (Suppl 2): P292.
Results Reference
background
Citation
Flisser E, Krey LC, Berkeley AS (2005) Diminishing Returns of Increasing Gonadotropin Dosage in Subsequent In Vitro Fertilization (IVF) Cycles?. Fertil Steril 84 (Suppl 1) P483.
Results Reference
background
PubMed Identifier
26361207
Citation
Lefebvre J, Antaki R, Kadoch IJ, Dean NL, Sylvestre C, Bissonnette F, Benoit J, Menard S, Lapensee L. 450 IU versus 600 IU gonadotropin for controlled ovarian stimulation in poor responders: a randomized controlled trial. Fertil Steril. 2015 Dec;104(6):1419-25. doi: 10.1016/j.fertnstert.2015.08.014. Epub 2015 Sep 8.
Results Reference
derived
Links:
URL
http://www.ovoclinic.com/
Description
OVO fertilité website

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Effect of a Higher Than Maximum 450IU Gonadotropin Dose in an In-vitro Fertilization Cycle

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