Adjuvant Growth Hormone in Infertile Women With Prior Poor IVF Response: a Randomized, Controlled, Open-label Study
Overview
- Phase
- Phase 2
- Intervention
- No Saizen Control (Standard IVF Protocol)
- Conditions
- Infertility
- Sponsor
- Pacific Centre for Reproductive Medicine
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Oocyte yield
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief Summary
This study (the "Adjuvant Growth Hormone Study") is being done to see the effects of adding Growth Hormone (GH) during fertility treatment (also called in vitro fertilization or IVF). Growth Hormone is a protein that your body normally produces. Growth Hormone can act on several different organs, including the ovaries, where eggs are made. From evidence gathered from studies done by fertility doctors over the years, researchers believe that women who have not become pregnant through IVF in the past might have better results if they go on a course of Growth Hormone during the IVF treatment. However, more research needs to be done to confirm whether adding Growth Hormone is beneficial and also to find out the best time to start Growth Hormone treatment during IVF.
We hope that our Adjuvant Growth Hormone study will help answer these questions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject with prior poor response(s) to ovarian stimulation for IVF or ICSI. Poor response is defined as a history of producing fewer than four follicles ≥14 mm in diameter during previous COS cycles where FSH or HMG was used from cycle start at a daily dose of ≥450 IU
- •Age ≤ 45 years
- •Baseline blood labs, measured within previous month, show fasting blood glucose \<6.1 mmol/L and TSH ≤ 5.5 mU/L
- •Early follicular phase (Day 2 or Day 3) serum FSH, evaluated in the preceding 6 months
- •Subject willing and able to give informed consent
Exclusion Criteria
- •Concurrently enrolled in any other clinical trial
- •Previous participation in this study
- •Using GnRH agonist in COS protocol
- •Any prior early follicular phase serum FSH level ≥12 IU/L
- •Use of any of the following is contraindicated or inappropriate: GH, Cetrotide®, FSH, LH or hCG
- •Used OCP within the prior month
- •Pregnant or lactating
- •Untreated hydrosalpinx
- •Tobacco smoker
- •Diabetic or otherwise at risk of gestational diabetes
Arms & Interventions
No Growth Hormone Supplementation
Intervention: No Saizen Control (Standard IVF Protocol)
Luteal Growth Hormone Start
Growth hormone starting in the luteal phase of the previous menstrual cycle.
Intervention: Saizen (Human Growth Hormone)
Follicular Growth Hormone Start
Starting growth hormone during the follicular phase of the prior menstrual cycle.
Intervention: Saizen (Human Growth Hormone)
Outcomes
Primary Outcomes
Oocyte yield
Time Frame: Following course of treatment (2-3 weeks)
To assess the effect of adjuvant GH on the number of mature oocytes recovered from women undergoing COS using a GnRH antagonist protocol.
Secondary Outcomes
- Pregnancy rate(Approximately 2 weeks following completion of treatment.)