Adjuvant Growth Therapy in in Vitro Fertilization

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715324
• Other study ID #: OVO-09-03
• Status: Completed
• Phase: Phase 4
• Start date: June 25, 2014
• Est. completion date: August 2021

Study information

• Verified date: January 2022
• Source: Clinique Ovo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: August 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
Canada	Clinique Ovo	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Clinique Ovo	EMD Serono

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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