Growth Hormone (GH) in in Vitro Fertilization (IVF) Poor-responder Patients (FUNDEX001)

Institut Universitari Dexeus

Status and phase

Terminated

Phase 2

Conditions

Complications; Artificial Fertilization, Introduction of Embryo in Embryo Transfer

Treatments

Drug: Somatropin

Study type

Interventional

Funder types

Other

Identifiers

NCT01298960

2010-022151-32 (EudraCT Number)

FUNDEX001

Details and patient eligibility

About

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

Enrollment

52 patients

Sex

Female

Ages

18 to 39 years old

Volunteers

No Healthy Volunteers

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.