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

Institut Universitari Dexeus1 site in 1 country52 target enrollmentFebruary 2011

ConditionsComplications; Artificial Fertilization, Introduction of Embryo in Embryo Transfer

InterventionsSomatropin

DrugsSomatropin

Overview

Phase: Phase 2
Intervention: Somatropin
Conditions: Complications; Artificial Fertilization, Introduction of Embryo in Embryo Transfer
Sponsor: Institut Universitari Dexeus
Enrollment: 52
Locations: 1
Primary Endpoint: Number of metaphase II oocytes retrieved
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

June 2013

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Institut Universitari Dexeus

Responsible Party

Principal Investigator

Ignacio Rodriguez MSc

BSC

Institut Universitari Dexeus

Eligibility 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 \<
•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.