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Human Growth Hormone Pre-treatment for 6 Weeks Prior to Ovulation Induction for IVF

NCT02179255 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-02-18

No results posted yet for this study

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.

Conditions

  • Female Infertility Due to Diminished Ovarian Reserve

Interventions

DRUG

Human Growth Hormone

1.9 mg (5.7 units) daily injection of Recombinant Human Growth Hormone (HGH) for at least 6 weeks (42 days) continuing into the approximately 14 days of ovulation induction phase of the trial.

DRUG

Follicle Stimulating Hormone

FSH 450 to 600 units per day administered SQ daily dose adjusted based on the patients response starting on day 2 of the 28 day menstrual cycle and continued until Ovulation trigger

Sponsors & Collaborators

  • Center for Human Reproduction

    lead OTHER

Principal Investigators

  • David H Barad, MD · Center for Human Reproduction

  • Norbert Gleicher · Center for Human Reproduction

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-01
Primary Completion
2021-06-30
Completion
2022-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02179255 on ClinicalTrials.gov