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

Tracking Information

First Received Date ^ICMJE

February 17, 2011

Last Updated Date

March 26, 2013

Start Date ^ICMJE

February 2011

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01298960 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Pregnancy rate [ Time Frame: 9 months after ovum pick-up ] [ Designated as safety issue: No ]
Adverse events due to rGH [ Time Frame: During study period ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Complications; Artificial Fertilization, Introduction of Embryo in Embryo Transfer

Intervention ^ICMJE

Drug: Somatropin

0.1 IU/Kg/day from day one of stimulation until rHCG triggering

Study Arm (s)

Experimental: rGH Group
Intervention: Drug: Somatropin
No Intervention: Non rGH group

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 39 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01298960

Other Study ID Numbers ^ICMJE

FUNDEX001, 2010-022151-32

Has Data Monitoring Committee

Responsible Party

Fundación Santiago Dexeus Font

Study Sponsor ^ICMJE

Institut Universitari Dexeus

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Institut Universitari Dexeus

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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