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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Institut Universitari Dexeus
ClinicalTrials.gov Identifier:
NCT01298960
First received: February 17, 2011
Last updated: March 26, 2013
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Complications; Artificial Fertilization, Introduction of Embryo in Embryo Transfer
 Drug: Somatropin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Randomized Study of Cotreatment With Growth Hormone in a Long GnRH Agonist Protocol in Women With Previous Poor Ovarian Response

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Institut Universitari Dexeus:

Primary Outcome Measures:
  • Number of metaphase II oocytes retrieved [ Time Frame: 3 months after having finished recruitment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy rate [ Time Frame: 9 months after ovum pick-up ] [ Designated as safety issue: No ]
  • Adverse events due to rGH [ Time Frame: 3 months after having finished recruitment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 52
Study Start Date: February 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rGH Group Drug: Somatropin
0.1 IU/Kg/day from day one of stimulation until rHCG triggering
No Intervention: Non rGH group

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298960

Locations
Spain
Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus
Barcelona, Spain, 08037
Sponsors and Collaborators
Institut Universitari Dexeus
Investigators
Study Chair: Pedro N Barri, PhD, MD Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus
Principal Investigator: Buenaventura Coroleu, PhD. MD Departament of Obstetrics, Gyneacology and Reproductive Medine, Institut Universitari Dexeus
Principal Investigator: Marta Devesa, MD Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus
Principal Investigator: Francisca Martinez, PhD. MD Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Fundación Santiago Dexeus Font
ClinicalTrials.gov Identifier: NCT01298960     History of Changes
Other Study ID Numbers: FUNDEX001, 2010-022151-32
Study First Received: February 17, 2011
Last Updated: March 26, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica

Keywords provided by Institut Universitari Dexeus:
Poor Ovarian response in IVF
Metaphase II oocytes
Pregnancy Rate
Growth Hormone

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013