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

Study Overview
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Brief Summary
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Experimental study to evaluate if rGH addition to a standard controlled ovarian stimulation treatment improves ovarian response in women with previous poor ovarian response.

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

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

Intervention / Treatment
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* Drug: Somatropin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rGH Group<br> | Drug: Somatropin<br>* 0.1 IU/Kg/day from day one of stimulation until rHCG triggering<br>|
| No Intervention: Non rGH group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of metaphase II oocytes retrieved |  | 3 months after having finished recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate |  | 9 months after ovum pick-up | 
| Adverse events due to rGH |  | 3 months after having finished recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Poor Ovarian response in IVF, Metaphase II oocytes, Pregnancy Rate, Growth Hormone