Poor Ovarian Response Clinical Trial
Official title:
Will Long-term Endogenous Androgen Priming, Using a Combination of Low Dose HCG and Aromatase Inhibitor in Bologna Criteria Poor Responder Patients Increase Ovarian Reserve Parameters - A Pilot Study
Until now no scientific clinical evidence exists regarding the possible impact of long term endogenous androgen priming in IVF patients aligned with the Bologna Criteria, in specific the impact of priming on serum parameters correlated with the ovarian reserve, antral follicle count, and the number of retrievable follicles. Thus, this pilot-study will explore a new suggested protocol for the Bologna criteria patient developed from basic physiology, and will if successful result in a subsequent randomized controlled trial in the same subset of patients, enabling a possible paradigm shift in the treatment of poor ovarian response (POR).
A single center study pilot study in 30 IVF Bologna criteria POR patients. All patients
fulfilling the ESHRE Bologna criteria will be eligible for inclusion.
Eight weeks prior to stimulation for IVF, patients will start treatment with a low dose of
rhCG (Ovitrelle). At the same time daily treatment with the aromatase inhibitor daily will
commence, concomitantly with GnRHa down-regulation with a depot GnRHa.
After 8 weeks, stimulation will be performed with a fixed dose of 300 IU rFSH (Gonal F,
Merck) for the first 5 days in patients ≤ 34 years of age and 300 IU Pergoveris (Merck) in
patients ≥ 35 years of age. The use of hCG and aromatase inhibitor will stop on the first day
of stimulation.
Monitoring will be performed according to the standard procedure of the clinic. Patients will
receive a bolus of 6.500 IU rhCG (Ovitrelle, Merck) for triggering of final oocyte
maturation. Oocyte pick-up and embryo transfer will be performed according to the policy of
the clinic. Oocyte pick-up (OPU) and embryo transfer will be performed according to standard
procedures.
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