Growth Hormone (GH) in in Vitro Fertilization (IVF) Poor-responder Patients
NCT ID: NCT01298960
Last Updated: 2020-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
52 participants
INTERVENTIONAL
2011-02-28
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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rGH Group
Somatropin
0.1 IU/Kg/day from day one of stimulation until rHCG triggering
Non rGH group
No interventions assigned to this group
Interventions
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Somatropin
0.1 IU/Kg/day from day one of stimulation until rHCG triggering
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
39 Years
FEMALE
No
Sponsors
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Fundacion Dexeus
OTHER
Responsible Party
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Ignacio Rodriguez MSc
BSC
Principal Investigators
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Pedro N Barri, PhD, MD
Role: STUDY_CHAIR
Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus
Buenaventura Coroleu, PhD. MD
Role: PRINCIPAL_INVESTIGATOR
Departament of Obstetrics, Gyneacology and Reproductive Medine, Institut Universitari Dexeus
Marta Devesa, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus
Francisca Martinez, PhD. MD
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus
Locations
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Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus
Barcelona, , Spain
Countries
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References
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Harper K, Proctor M, Hughes E. Growth hormone for in vitro fertilization. Cochrane Database Syst Rev. 2003;(3):CD000099. doi: 10.1002/14651858.CD000099.
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.
Related Links
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Related Info
Other Identifiers
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2010-022151-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FUNDEX001
Identifier Type: -
Identifier Source: org_study_id
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