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

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Universitari Dexeus
• Treatments: Hormones

Criteria

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.