This phase 4 trial aims to evaluate if co-administration of a gonadotrophin releasing-hormone (GnRH) agonist improves oocycte maturity.
The main outcome to be investigated is the number of mature oocytes.
One of the important steps during in vitro fertilization (IVF) is stimulating the maturation of oocytes (eggs). GnRH agonists are drugs which act similarly to the body’s natural GnRH. GnRH stimulates the release of other hormones that are important in the female reproductive system. Several retrospective studies suggest that combining a GnRH agonist with standard human chorionic gonadotrophin (hCH) treatment may improve oocyte maturation and pregnancy rates.
This study will determine if co-administration of GnRH agonist enhances oocyte maturation in combination with hCG treatment.
Who are they looking for?
This study will recruit approximately 276 female patients (aged 18-42 years) undergoing one of their first 3 IVF cycle attempts. Patients should be healthy with a BMI (body mass index) of 18-35. Patients must also have an anti-mullerian hormone (AMH) level of greater than 1 ng/ml and follicle stimulating hormone (FSH) level of less than 20 IU/L.
Patients cannot take part in the trial if they have a low ovarian response, primary ovarian failure or hypersensitivity to any of the medications to be administered during the trial. Other exclusion criteria include: uncontrolled hypertension, diabetes, abnormal kidney and liver function, cancer and HIV, HBV or HCV infections.
How will it work
Patients will undergo a standard clinical and hormonal investigation for IVF patients. Patients will be randomly assigned to 2 groups. One group will receive pregnyl (hCG, 10,000 IU) and suprefact (GnRH agonist, 0.5mg). The other group will receive pregnyl and placebo (inactive drug). All patients will receive additional progesterone as per standard treatment.
The effectiveness of the treatment will be assessed by measuring the number of mature oocytes produced 2 days following treatment.