Adjuvant Growth Therapy in in Vitro Fertilization

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Drug: Adjuvant Growth Hormon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Growth Hormon<br>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<br>* 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<br>* Other names: Saizen;|
| No Intervention: Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group. | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In vitro fertilization, Antagonist protocol, Growth Hormone