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Adjuvant Growth Therapy in in Vitro Fertilization

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by OVO R & D
Sponsor:
Collaborator:
EMD Serono
Information provided by (Responsible Party):
OVO R & D
ClinicalTrials.gov Identifier:
NCT01715324
First received: October 24, 2012
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

In an In Vitro Fertilization (IVF) cycle super ovulating drugs (gonadotropins) are usually taken to stimulate the ovaries to produce more than one egg. In Vitro Fertilization protocols are constantly under review in order to improve the recruitment of the follicles, which contain the eggs, whilst minimizing the doses of gonadotrophins required, with the ultimate aim of increasing the live birth rate.

The addition of growth hormone, which is a biological hormone that can be synthetically produced, as a supplement to gonadotrophins in an In Vitro Fertilization cycle has been suggested as a way in which In Vitro Fertilization pregnancy rates may be increased.Growth hormone has been shown, in animal and human studies, to be important in the recruitment of follicles.However, to date, only a limited number of clinical studies have been performed in order to assess whether the addition of growth hormone can improve the probability of pregnancy in women undergoing ovarian stimulation for In Vitro Fertilization. As the total number of patients analysed in these studies was small it has not been possible to determine whether if there is any improvement the outcome of an In Vitro Fertilization cycle when a woman is given growth hormone therapy as a supplement during her treatment.

This goal of this study is to determine the effectiveness of using growth hormone therapy as a supplement to the administration of gonadotropins in an antagonist In Vitro Fertilization protocol.


Condition Intervention Phase
Infertility
Drug: Adjuvant Growth Hormon
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Growth Therapy in in Vitro Fertilization: A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by OVO R & D:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    To determine if the clinical pregnancy rate during the course of one treatment cycle in women receiving Growth Hormone daily in addition to gonadotropin-releasing hormone antagonist protocol is significantly higher than those receiving only gonadotropin-releasing hormone antagonist protocol (control group).


Secondary Outcome Measures:
  • Total dose of gonadotropins [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.

  • Number of observed follicles [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.

  • Number of mature (Metaphase II) oocytes retrieved [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.

  • Oocyte morphology [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.

  • Fertilization rate [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.

  • Embryo morphology [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.

  • Embryo cleavage rate [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.

  • Number of embryos available [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.

  • Number of supernumerary embryos available for cryopreservation [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.

  • Implantation rate [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.

  • Miscarriage rate [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.

  • Live birth rate [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.

  • Adverse side effects in women [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
    To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.


Estimated Enrollment: 528
Study Start Date: September 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Growth Hormon
The participants randomized in the control group will be prescribed a regular antagonist IVF cycle with dose appropriate stimulation medication and will receive 2.5 mg of Adjuvant Growth Hormon (Saizen) daily via subcutaneous injections, from the beginning of the ovarian reserve stimulation until the day of the ovulation triggering.
Drug: Adjuvant Growth Hormon
The treatment group will receive 2.5 mg of Saizen daily via subcutaneous injections, from the beginning of the ovarian reserve stimulation until the day of the ovulation triggering
Other Name: Saizen
No Intervention: Control
The participants randomized in the control group will be prescribed a regular antagonist IVF cycle with dose appropriate stimulation medication without Adjuvant Growth Hormon (Saizen).

  Eligibility

Ages Eligible for Study:   35 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women between the ages of 35 to 42
  • Primary or secondary infertility)

    • No previous treatment IVF cycle using the same proposed protocol
  • Negative pregnancy test at randomization (urine or blood)

Exclusion Criteria:

  • Contraindication to Saizen®
  • Simultaneous participation in another clinical trial
  • follicle stimulating hormone > 12 IU/L and/or anti-mullerian hormone < 0.5 pg/ml
  • Body mass index ≥ 35 kg/m2
  • Known risk of gestational diabetes
  • Administration of any investigational medication three months prior to study enrolment
  • Positive results of screening for either partner for HIV antibodies, Hepatitis B (other than surface antibodies present after vaccination) or Hepatitis C
  • Not able to communicate in French or English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715324

Contacts
Contact: Nelly Delouya, RN (514) 798-2000 ext 759 n.delouya@cliniqueovo.com
Contact: Sophie Leblanc, RN 514-798-2000 ext 617 s.leblanc@cliniqueovo.com

Locations
Canada, Quebec
Clinique Ovo Recruiting
Montreal, Quebec, Canada, H4P 2S4
Contact: Shirley Brugerie, Director    (514) 798-2000 ext 753    s.brugerie@cliniqueovo.com   
Contact: Nelly Delouya, RN    514-798-2000 ext 759    n.delouya@cliniqueovo.com   
Principal Investigator: Jacques Kadoch, MD         
Sponsors and Collaborators
OVO R & D
EMD Serono
Investigators
Principal Investigator: Jacques Kadoch, MD OVO R & D
  More Information

No publications provided

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01715324     History of Changes
Other Study ID Numbers: OVO-09-03
Study First Received: October 24, 2012
Last Updated: May 12, 2014
Health Authority: Canada: Health Canada

Keywords provided by OVO R & D:
In vitro fertilization
Antagonist protocol
Growth Hormone

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on November 27, 2014