Low-dose GH Supplementation Increases Clinical Pregnancy Rate

Study Overview
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Brief Summary
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The objective of this study is to assess whether a low dose of GH supplementation (0.5 IU/day) increases clinical pregnancy rates in women with a history of POR who failed to become pregnant in two previous IVF cycles.

Detailed Description
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The investigators aim to study the impact of a low-dose growth hormone (GH) supplementation in pregnancy rates in poor responders in a prospective, self-controlled study of 64 poor responders to previous IVF cycles who failed to achieve pregnancy and were supplemented with low-doses of GH in a subsequent cycle using the same gonadotropin dose and protocol. Our primary endpoint was the clinical pregnancy rate (CPR), considering secondary endpoints the number of retrieved oocytes, embryos, embryo quality and the proportion of cycles with embryo transfer. Controlled ovarian hyperstimulation will be performed using a GnRH agonist long protocol from day 21-23 of the menstrual cycle at a dose of 1 mg/ day, using the same schedule and dose as in the previous cycle, so that the only difference between them is the GH supplementation. After confirming pituitary inhibition, the dose of GnRH agonist will be decreased to 0.5 mg/day, and COH will begin with gonadotropins at a dose of 300 UI, subsequently adjusting according to clinical response. Human chorionic gonadotropin (hCG) will be administered when follicles reached > 17 mm in diameter. A dose of 0.5 IU of GH will be administered daily from the first day of the agonist until the day of hCG administration. Oocyte retrieval will be performed 36 hours after hCG administration by ultrasound-guided follicle aspiration.

Official Title
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Low-dose Growth Hormone Supplementation Increases Clinical Pregnancy Rate in Poor Responders Undergoing in Vitro Fertilisation.

Conditions
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Infertility

Intervention / Treatment
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* Drug: Growth Hormone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with a history of POR, defined according to the Bologna criteria Absence of pregnancy in at least two previous IVF cycles Exclusion Criteria: Body mass index ≥ 30 kg/m2 Presence of endocrinopathies Altered karyotype in one or both partners History of invasive ovarian surgery History of chronic, autoimmune or metabolic diseases Altered meiosis in testicular biopsy or altered sperm-FISH Drug therapy in the male partner Participation, within the previous 6 months, in another clinical trial with medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GH cycle<br>Subsequent IVF cycle, supplemented with a low dose of growth hormone. | Drug: Growth Hormone<br>* A dose of 0.5 IU of growth hormone will be administered daily from the first day of the agonist until the day of hCG administration<br>* Other names: Somatotropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound | 7 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrieved oocytes | Total number of retrieved oocytes | On egg retrieval day | 
| Number of obtained embryos | Total number of obtained embryos | 3 days after egg retrieval | 
| Embryo quality | Total number of top quality embryos per cycle | 3 days after embryo transfer | 
| Proportion of cycles with embryo transfer | Proportion of cycles reaching embryo transfer per initiated cycle | 3 days after egg retrieval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, Poor ovarian response, Growth hormone