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Growth Hormone (GH) in in Vitro Fertilization (IVF) Poor-responder Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT01298960•Fundacion Dexeus

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 39 years

Sex

FEMALE

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.
+2 more criteria

Locations (1)

Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus

Barcelona, Spain

Key Dates

Start Date

February 1, 2011

Primary Completion Date

June 1, 2013

Completion Date

June 1, 2013

Last Updated

February 12, 2020

Enrollment

ACTUAL participants

Conditions

Complications; Artificial Fertilization, Introduction of Embryo in Embryo Transfer

Interventions

Somatropin

DRUG