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

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ClinicalTrials.gov Identifier: NCT01298960
Recruitment Status : Suspended
First Posted : February 18, 2011
Last Update Posted : July 1, 2015
Sponsor:
Information provided by (Responsible Party):
Ignacio Rodriguez, Institut Universitari Dexeus

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2011
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Arm Intervention/treatment
Experimental: rGH Group Drug: Somatropin
0.1 IU/Kg/day from day one of stimulation until rHCG triggering
No Intervention: Non rGH group



Primary Outcome Measures :
  1. Number of metaphase II oocytes retrieved [ Time Frame: 3 months after having finished recruitment ]

Secondary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 9 months after ovum pick-up ]
  2. Adverse events due to rGH [ Time Frame: 3 months after having finished recruitment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Responsible Party: Ignacio Rodriguez, BSC, Institut Universitari Dexeus
ClinicalTrials.gov Identifier: NCT01298960     History of Changes
Other Study ID Numbers: FUNDEX001
2010-022151-32 ( EudraCT Number )
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: July 1, 2015
Last Verified: June 2015

Keywords provided by Ignacio Rodriguez, 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