Clinical trial NCT01298960: Growth Hormone (GH) in in Vitro Fertilization (IVF) Poor-responder Patients
Official title: Phase II Randomized Study of Cotreatment With Growth Hormone in a Long GnRH Agonist Protocol in Women With Previous Poor Ovarian Response
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Complications; Artificial Fertilization, Introduction of Embryo in Embryo Transfer
Keywords: Poor Ovarian response in IVF
Metaphase II oocytes
Pregnancy Rate
Growth Hormone
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Number of metaphase II oocytes retrieved
timeFrame: 3 months after having finished recruitment
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 9 months after ovum pick-up
measure: Adverse events due to rGH
timeFrame: 3 months after having finished recruitment
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus
Study officials:
affiliation: Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus
name: Pedro N Barri, PhD, MD
role: STUDY_CHAIR
affiliation: Departament of Obstetrics, Gyneacology and Reproductive Medine, Institut Universitari Dexeus
name: Buenaventura Coroleu, PhD. MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus
name: Marta Devesa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus
name: Francisca Martinez, PhD. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harper K, Proctor M, Hughes E. Growth hormone for in vitro fertilization. Cochrane Database Syst Rev. 2003;(3):CD000099. doi: 10.1002/14651858.CD000099.
citation: Kolibianakis EM, Venetis CA, Diedrich K, Tarlatzis BC, Griesinger G. Addition of growth hormone to gonadotrophins in ovarian stimulation of poor responders treated by in-vitro fertilization: a systematic review and meta-analysis. Hum Reprod Update. 2009 Nov-Dec;15(6):613-22. doi: 10.1093/humupd/dmp026. Epub 2009 Jun 26.