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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 28, 2014