Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response

Study Overview
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Brief Summary
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In this study, the investigators will assess the efficacy of growth hormone co-stimulation to GnRH antagonist regimen in poor responders to COH for IVF.

Detailed Description
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To date, a limited number of studies have been performed in order to assess whether the addition of GH can improve the probability of pregnancy in poor responders undergoing ovarian stimulation for IVF. Moreover, the existing studies are underpowered and, thus, inconclusive. In this study, the investigators will assess the efficacy of growth hormone co-stimulation to GnRH antagonist regimen in poor responders to COH for IVF.

Official Title
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Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response

Conditions
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Infertility, Female

Intervention / Treatment
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* Drug: Growth hormone/HPuFSH/GnRH antagonist
* Drug: HPuFSH/GnRH antagonist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Serum anti-Müllerian hormone (AMH) less than 1.2 ng/ml Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 42 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Growth hormone/HPuFSH/GnRH antagonist<br>The patients receive growth hormone | Drug: Growth hormone/HPuFSH/GnRH antagonist<br>* Growth hormone (Somatropin, Sedico, Egypt) [4 IU/day] and highly purified urinary FSH (HPuFSH) (Fostimon,IBSA, Switzerland) [300 IU/day] will be started on cycle day 3 and will be continued until and including the day of human chorionic gonadotropin (HCG) administration. Starting from cycle day 8, the dose of HPuFSH will be adjusted individually according to ovarian response which will be monitored using transvaginal ultrasound and serum estradiol (E2). GnRH antagonist (Cetrorelix acetate) (Cetrotide; Serono International S.A., Geneva, Switzerland) 0.25 mg S.C. once daily will be started when the leading follicle is 14 mm in mean diameter and will be continued until and including the day of HCG administration.<br>|
| Active Comparator: HPuFSH/GnRH antagonist<br>Growth hormone is not used | Drug: HPuFSH/GnRH antagonist<br>* Highly purified urinary FSH (HPuFSH) (Fostimon,IBSA, Switzerland) [300 IU/day] will be started on cycle day 3 and will be continued until and including the day of human chorionic gonadotropin (HCG) administration. Starting from cycle day 8, the dose of HPuFSH will be adjusted individually according to ovarian response which will be monitored using transvaginal ultrasound and serum estradiol (E2). GnRH antagonist (Cetrorelix acetate) (Cetrotide; Serono International S.A., Geneva, Switzerland) 0.25 mg S.C. once daily will be started when the leading follicle is 14 mm in mean diameter and will be continued until and including the day of HCG administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants who achieved a clinical pregnancy in a transfer cycle |  | Five weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants who achieved a ongoing pregnancy in a transfer cycle |  | Eighteen weeks after embryo transfer | 

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