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

Sponsor

Institut Universitari Dexeus (Other)

Overall Status

Terminated

CT.gov ID

NCT01298960

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual 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

Actual Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of metaphase II oocytes retrieved [3 months after having finished recruitment]

Secondary Outcome Measures

Pregnancy rate [9 months after ovum pick-up]
Adverse events due to rGH [3 months after having finished recruitment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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