Human Growth Hormone Pre-treatment for 6 Weeks Prior to Ovulation Induction for IVF
Status:
Enrolling by invitation
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
Synthetic human growth hormone (HGH) has been available for more than a decade for specific
indication in children and adults. Past Randomized Control Trials (RCT)s of HGH (under
off-label use) for improving ovarian function have shown that a combination of traditional
gonadotropin ovulation induction protocols, with addition of HGH is effective in increasing
pregnancy rates, but not increasing egg production after IVF in women with documented
diminished ovarian reserve (DOR). The investigators hypothesize that by initiating HGH at
least 6 weeks prior to IVF start, the investigators will be able to increase production of
oocytes and further improve pregnancy chances. This hypothesis is based on prior observations
of effects of growth hormone on small antral follicles and the fact that prior studies
utilized HGH principally only during ovulation induction itself.
The investigators plan to recruit 30 women (15 in each group) to an open label randomized
controlled trial of HGH for augmentation of ovarian response among women with documented DOR
and poor prior response to ovulation induction.
Eligible participants will be women < 45 years with documented history of prior retrieval of
2 or fewer oocytes while on maximal ovulation induction despite prior supplementation with
dehydroepiandrosterone (DHEA).
Women will be treated with 1.9 mg (5.7 units) of HGH per day, beginning about 6 weeks before
start of their treatment cycle. Cost of treatment with HGH will be a cost to the
participating patient. HGH will cost the patient approximately $800 per week of treatment.
Patients who are randomized to the non-HGH treated group, and do not conceive, will in the
following cycle be offered HGH supplementation outside of this clinical trial. This
subsequent cycle will not be part of the study dataset and patients will also be responsible
for the cost of HGH.
Even with only 7 patients in each group, this trial will have a 99% power (error 0.05%) to
detect a mean increase to 4 oocytes in the treated group. The investigators plan to recruit
15 patients in each group to allow for possible dropouts.