Trial | NCT01298960  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    somatropin ...

  • Study Participants

    52
Experimental study to evaluate if rGH addition to a standard controlled ovarian stimulation treatment improves ovarian response in women with previous poor ovarian response.
Study Started
Feb 28
2011
Primary Completion
Jun 30
2013
Study Completion
Jun 30
2013
Last Update
Feb 12
2020

Drug Somatropin

0.1 IU/Kg/day from day one of stimulation until rHCG triggering

rGH Group Experimental

Non rGH group No Intervention

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.
No Results Posted