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

Complications; Artificial Fertilization, Introduction of Embryo in Embryo Transfer Clinical Trial

— FUNDEX001  

Official title:

Phase II Randomized Study of Cotreatment With Growth Hormone in a Long GnRH Agonist Protocol in Women With Previous Poor Ovarian Response

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01298960
• Other study ID #: FUNDEX001
• Secondary ID: 2010-022151-32
• Status: Terminated
• Phase: Phase 2
• Start date: February 2011
• Est. completion date: June 2013

Study information

• Verified date: February 2020
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complications; Artificial Fertilization, Introduction of Embryo in Embryo Transfer

Intervention

Drug:
• Somatropin
0.1 IU/Kg/day from day one of stimulation until rHCG triggering

Locations

Country	Name	City	State
Spain	Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Universitari Dexeus

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Harper K, Proctor M, Hughes E. Growth hormone for in vitro fertilization. Cochrane Database Syst Rev. 2003;(3):CD000099. Review. Update in: Cochrane Database Syst Rev. 2009;(4):CD000099. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of metaphase II oocytes retrieved		3 months after having finished recruitment
Secondary	Pregnancy rate		9 months after ovum pick-up
Secondary	Adverse events due to rGH		3 months after having finished recruitment

External Links

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