Adjuvant Growth Therapy in in Vitro Fertilization

January 7, 2022 updated by: Clinique Ovo

Adjuvant Growth Therapy in in Vitro Fertilization: A Randomized Control Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

288

Phase

  • Phase 4

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4P 2S4
        • Clinique OVO

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

35 years to 42 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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
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 Names:
  • 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 7 weeks
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).
7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total dose of gonadotropins
Time Frame: 7 weeks
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
7 weeks
Number of observed follicles
Time Frame: 7 weeks
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
7 weeks
Number of mature (Metaphase II) oocytes retrieved
Time Frame: 7 weeks
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
7 weeks
Oocyte morphology
Time Frame: 7 weeks
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
7 weeks
Fertilization rate
Time Frame: 7 weeks
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
7 weeks
Embryo morphology
Time Frame: 7 weeks
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
7 weeks
Embryo cleavage rate
Time Frame: 7 weeks
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
7 weeks
Number of embryos available
Time Frame: 7 weeks
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
7 weeks
Number of supernumerary embryos available for cryopreservation
Time Frame: 7 weeks
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
7 weeks
Implantation rate
Time Frame: 7 weeks
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
7 weeks
Miscarriage rate
Time Frame: 40 weeks
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
40 weeks
Live birth rate
Time Frame: 40 weeks
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
40 weeks
Adverse side effects in women
Time Frame: 7 weeks
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
7 weeks

Collaborators and Investigators

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

Sponsor

Clinique Ovo

Collaborators

EMD Serono

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 (ACTUAL)

June 25, 2014

Primary Completion (ACTUAL)

July 1, 2021

Study Completion (ACTUAL)

August 1, 2021

Study Registration Dates

First Submitted

October 24, 2012

First Submitted That Met QC Criteria

October 24, 2012

First Posted (ESTIMATE)

October 26, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 7, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OVO-09-03

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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