Growth Hormone in Poor Responders to IVF Trial
- Conditions
- Infertility
- Interventions
- Registration Number
- NCT01616225
- Lead Sponsor
- Pacific Centre for Reproductive Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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
- BMI > 38 kg/m2
- Poorly controlled thyroid disease
- Known cancer or prior history of malignancies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No Growth Hormone Supplementation No Saizen Control (Standard IVF Protocol) - Follicular Growth Hormone Start Saizen (Human Growth Hormone) Starting growth hormone during the follicular phase of the prior menstrual cycle. Luteal Growth Hormone Start Saizen (Human Growth Hormone) Growth hormone starting in the luteal phase of the previous menstrual cycle.
- Primary Outcome Measures
Name Time Method Oocyte yield 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 Outcome Measures
Name Time Method Pregnancy rate Approximately 2 weeks following completion of treatment. To assess the effect of adjuvant GH on: the proportion of subjects reaching embryo transfer; embryo quality; implantation rate; clinical pregnancy rate evaluated 5 weeks after IVF/ICSI (week 7 of gestation); proportion of subjects with clinical pregnancy; mean (SD) crown-rump length 5 weeks after IVF/ICSI (week 7 of gestation); proportion of subjects with a viable fetus(es) at week 12 of gestation; proportion of subjects with live births; duration of FSH stimulation; ampules of FSH consumed; and safety.
Trial Locations
- Locations (1)
Pacific Centre for Reproductive Medicine
🇨🇦Burnaby, British Columbia, Canada