The effect of using Growth Hormone in Invitro Fertilisation on livebirth rates
A randomised, double blind placebo controlled study assessing the effect of recombinant human growth hormone (r-hGH) on live birth rates in women who are poor responders undergoing an Invitro Fertilisation(IVF) or Intracytoplasmic Sperm Injection(ICSI) cycle.
Robinson Institute
389 participants
Oct 25, 2010
Interventional
Conditions
Summary
It is well known that the chance of live birth in assisted reproduction treatment decreases with increasing female age, and drops markedly after 40 years of age, however, some woman younger than this is an ‘unexpected poor responder’ during their IVF cycle. Tesarik reported in 2005 that the ability of human oocytes to form normal embryos is related to the concentration of different hormones in follicular fluid (Mendoza et al., 1999, 2002). Among the hormones studied, growth hormone (GH) showed the most consistent relationship with different parameters of embryo quality, and higher concentrations of GH in follicular fluid were associated with rapid embryo cell division, good embryo morphology and a high embryo implantation potential (Mendoza et al., 1999, 2002).He also reports a decrease in follicular fluid GH concentration in women aged 40 years as compared with young women. Studies evaluating the benefits of co-treatment with recombinant human Growth Hormone (r-hGH) during controlled ovarian stimulation for human assisted reproduction treatment have reported controversial findings. A Cochrane review (Harper et al. 2008) and updated as part of a review of the management of poor responders (Kyrou et al. 2008), suggest that there exists some evidence for the use of GH in the management of IVF cycles of poor responders. The aim of this study is to determine the influence of GH treatment as an adjunct to stimulation with the maximal dose of Follicle Stimulating Hormone(FSH) stimulation in the unexpected poor responding IVF patient, ie patients requiring maximal dose of stimulation despite being under 41 years of age.
Eligibility
Inclusion Criteria10
- Have early follicular phase (Day 2-6) serum levels within the last 3 months prior to study entry of: FSH less than or equal to 15 IU/L and no recorded FSH level ever greater than 15IU/L
- Have a regular spontaneous menstrual cycle between 21 and 35 days in length.
- Have had a previous IVF/ICSI cycle resulting in collection of less than or equal to 5 oocytes.
- Be ordered a starting dose of ovarian stimulation of r-FSH of greater than or equal to 250 and less than or equal to 450 IU
- A body mass index (BMI) less than or equal to 32 kg/m2
- Have access to ejaculatory sperm. If not, the subject can only be entered if donor sperm will be used.
- Presence of both ovaries.
- Have a uterine cavity without abnormalities, which, in the investigator’s opinion, could impair embryo implantation or pregnancy evolution as assessed within the last 3 years using ultrasound (US), hysteroscopy (HSC), or hysterosalpingography (HSG).
- Have a negative cervical PAP test within the last 12 months prior to study entry, as evidenced by laboratory report in subject’s medical notes.
- have a normal fasting blood glucose level
Exclusion Criteria14
- A history or current presence of Polycystic Ovarian Syndrome (PCOS) (Rotterdam criteria)
- Azoospermia requiring testicular sperm extraction
- Undergoing Preimplantation Genetic Screening during her IVF/ICSI cycle
- Previous chemotherapy and /or radiotherapy treatment
- Had previous severe ovarian hyper stimulation syndrome (OHSS).
- Any contraindication to being pregnant and/or carrying a pregnancy to term.
- A history of or current presence of tumours of the hypothalamus and pituitary gland.
- Current ovarian enlargement or ovarian cyst of unknown aetiology
- Current or past history of clinically significant systemic disease, including chronic kidney or liver disease, diabetes mellitus type I & II, uncontrolled thyroid disease, any autoimmune disease
- Current chronic infectious disease, including positive result for Hepatitis B, Hepatitis C, HumanImmunodeficency Virus (HIV)
- Acute or severe illness during the previous 6 months considered clinically significant according to clinician assessment
- Current or past history of malignancies including ovarian, uterine or breast cancer (except non-melanomatous skin malignancies)
- Abnormal gynaecological bleeding of undetermined origin
- Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years, according to clinical assessment including current smoking.
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Interventions
administration of Growth Hormone 12IU given daily as a subcutaneous injection from day 1of IVF ovarian stimulation using recombinant follicle stimulating hormone administration to day of oocyte maturation
Locations(2)
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ACTRN12609001060235