Growth Hormone (GH) in in Vitro Fertilization (IVF) Poor-responder Patients (NCT01298960) | Clinical Trial Compass
TerminatedPhase 2
Growth Hormone (GH) in in Vitro Fertilization (IVF) Poor-responder Patients
Spain52 participantsStarted 2011-02
Plain-language 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.
Who can participate
Age range18 Years – 39 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Number of metaphase II oocytes retrieved
Timeframe: 3 months after having finished recruitment