CHR is conducting a open-label, prospectively randomized clinical trial on the effects of human growth hormone (HGH) used in conjunction with ovulation induction for in vitro fertilization (IVF). The aim of this study is to determine whether adding human growth hormone during the early stage of follicle development improves ovarian response to gonadotropin stimulation for IVF. Patients who have failed to respond to ovarian stimulation while on DHEA supplementation, or had 2 eggs or fewer, will be invited to participate in the HGH trial.
After years of revolutionary research on the positive effects of DHEA on ovarian reserve, CHR now routinely recommends DHEA supplementation to women of all ages with diminished ovarian reserve (DOR). While DHEA supplementation has helped many women conceive with their own eggs, both here at CHR at other centers that have adopted our DHEA protocol, there are still women whose ovarian reserve is so low that even DHEA supplementation is not enough. After careful review of literature, CHR is now investigating a new protocol to help this group of women, involving human growth hormone (HGH) as an adjuvant to ovarian stimulation with gonadotropins.
Human growth hormone (HGH) is a hormone that raises blood sugar, free fatty acids and insulin-like growth factors (IGFs), which stimulates the production of proteins. HGH as a medication is best known for its use in short-stature children.
HGH and IGFs closely interact. HGH stimulates the production of IGF-1, one of the two IGFs. This HGH-IGF "axis" plays an important role in cell proliferation and inhibits apoptosis (cell death). This "axis" has been associated with a number of normal physiological processes, including follicle maturation (growth of eggs) in the ovaries.
This is an area of controversy, with conflicting results from studies trying to determine the efficacy of HGH use as an adjuvant to gonadotropins in ovarian stimulation. After a careful review of the published data, CHR has decided that the likely reason behind the conflicting reports is the poor timing of HGH administration. Administering HGH for only a short period of time during or before stimulation, most of the published studies missed the most important time period, when the follicles are still small and are most receptive to IGF-1's proliferative effects.
In an analogy to DHEA supplementation, CHR investigators hypothesized that HGH may be more effective if administered at least 6-8 weeks before the IVF cycle starts, targeting these small, growing follicles. At this stage, CHR investigators believe that HGH may be able to improve the quality of eggs in the follicles, and this is the hypothesis of this clinical trial.
HGH clinical trail is offered to patients who are under 45 years of age, who have either failed to respond to CHR's standard ovarian stimulation while on DHEA supplementation, or who produced 2 or fewer eggs under the same protocol. If you are eligible for the study, your clinical coordinator will ask you if you want to participate in the study. If you agree to participate, you will need to sign an informed consent, after which you will be randomized into either the study group, which receives HGH injections, or the control group, which does not receive anything (no "fake" injections).
Unfortunately, human growth hormone is an expensive drug. We estimate about $6,000 of additional cost to patients who are randomized to the HGH arm of the trial.