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Completed

NCT Number: NCT01715324

Adjuvant Growth Therapy in in Vitro Fertilization

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.

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Key information

Age range

35 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adjuvant Growth Hormon

Drug

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

Clinique Ovo

Industry

Collaborators

  • EMD Serono

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Oct 26, 2012
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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