RecruitingPhase 3ACTRN12609001060235

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.


Sponsor

Robinson Institute

Enrollment

389 participants

Start Date

Oct 25, 2010

Study Type

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

Sex: FemalesMin Age: 18 YearssMax Age: 41 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding growth hormone (GH) to standard fertility treatment (IVF) can improve the chances of pregnancy in women who don't respond well to fertility drugs — meaning they produce very few eggs despite high doses of medication. Some research suggests GH improves egg quality, especially in women whose ovaries are not responding well. You may be eligible if: - You are a woman between 18 and 41 years old - You have had a previous IVF/ICSI cycle that collected 5 or fewer eggs - You have regular menstrual cycles (21–35 days) - You have both ovaries with a normal uterus - Your FSH (a hormone) level was normal in the past 3 months - Your BMI is 32 or less - You have a normal fasting blood sugar level You may NOT be eligible if: - You have polycystic ovarian syndrome (PCOS) - You have had previous chemotherapy or radiotherapy - You have a history of severe ovarian hyperstimulation syndrome - You have significant health conditions such as diabetes, kidney or liver disease, thyroid disease, or autoimmune conditions - You have a current or past cancer (except non-melanoma skin cancer) - You are a current smoker or have a history of substance abuse Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 matur

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)

Auckland, New Zealand

New Zealand

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ACTRN12609001060235