Growth Hormone (GH) in in Vitro Fertilization (IVF) Poor-responder Patients

Phase II Randomized Study of Cotreatment With Growth Hormone in a Long GnRH Agonist Protocol in Women With Previous Poor Ovarian Response

Experimental study to evaluate if rGH addition to a standard controlled ovarian stimulation treatment improves ovarian response in women with previous poor ovarian response.

Inclusion Criteria:

• Women who desire pregnancy with regular spontaneous menstrual cycles of 25-30 days length.
• Infertility requiring IVF with or without ICSI.
• Antecedent of a failed previous IVF cycle with a GnRH long agonist protocol in which at least 3000 IU of FSH were used (cancellation due to poor ovarian response - < 4 mature follicles - or less than 5 oocytes retrieved)and antral follicle count < 5.
• Partner sperm.
• Presence of both ovaries and normal uterine cavity.
• PAP smear within normality in previous 3 years.
• Negative pregnancy test (serum or urine) before rFSH administration.
• Willingness of adhesion to protocol during the whole study period.
• Signed informed consent given.

Exclusion Criteria:

• HIV, HCV, HBV positive serologies in women or partner.
• Important systemic diseases that could interfere with gonadotrophin treatment (ovarian and hypothalamic tumors...).
• BMI > 32 kg/m2 or antecedent of diabetes mellitus.
• Gonadotrophin treatment within the previous 30 days.
• Availability of frozen embryos of previous IVF cycles .
• Abnormal uterine bleeding.
• Previous treatment with LH or LH effect drugs.
• Polycystic ovaries, increased size ovaries or presence of ovarian cysts of unknown ethiology.
• Contraindication for pregnancy.
• Allergies to gonadotrophins or somatotropin.
• History of drug or alcohol abuse in the previous 5 years.
• Previous enrollment in this study or simultaneous participation in another study with drugs.