Effect of GH Administration in Poor Responders Undergoing Intracytoplasmic Sperm Injection (ICSI)

Study Overview
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Brief Summary
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Despite the use of various treatment strategies, poor response to ovarian stimulation remains a major clinical challenge with lower chance to obtain sufficient number of oocytes and thus less likely to conceive with high risk of cycle cancellation. The aim of this study is to evaluate the effect of recombinant human GH administration to gonadotropins on clinical and laboratory ICSI outcomes in expected poor responders more and less than 35 years (Poseidon group 4 and 3 respectively).

Official Title
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Effect of Growth Hormone Administration With Controlled Ovarian Stimulation in Expected Poor Responders POSEIDON Group 3 and 4 Undergoing ICSI Using Antagonist Protocol

Conditions
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Female Infertility

Intervention / Treatment
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* Drug: Growth Hormone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertile women aged 20-45 years. AFC <5. AMH level <1.2 ng/ml. Have two normal ovaries and normal uterine cavity. Exclusion Criteria: Body mass index (BMI) >30 kg/m2. Follicle Stimulating Hormone (FSH) > 15 IU/L. History of abnormal karyotype in one or both partners. Endocrine, metabolic or autoimmune disorders, such as diabetes, thyroid disorder, and polycystic ovary syndrome (PCOS). Women with a known medical disease (e.g. severe hypertension or hepatic disease). Endometriosis. Previous ovarian surgery. Current or history of malignancies, chemotherapy or radiotherapy. Severe male actor (total motile sperm count <1×106 or normal morphology <1%)

Ages Eligible for Study
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Minimum Age: 20 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: Poseidon Group 4A & 3A<br>80 eligible infertile women fulfilling the criteria of Poseidon Group 4 (35 years or more and AMH <1.2ng/ml) will be randomized into Group 4A will receive controlled ovarian stimulation (COS) and growth hormone (GH) and Group 4B will receive COS only. Similarly, 80 eligible infertile women fulfilling the criteria of Poseidon Group 3 (less than 35 years and AMH <1.2ng/ml) will be randomized into Group 3A will receive COS and GH and Group 3B will receive COS only. | Drug: Growth Hormone<br>* In GH groups (Group 4A & 3A), patients will receive additional treatment with GH (Somatropin, 4 IU/day, subcutaneous injection), daily beginning on the initial day of gonadotropin stimulation until triggering the oocyte maturation by hCG. Control groups (Group 4B & 3B) will receive only standard COS without GH supplementation<br>* Other names: somatropin 4 IU;|
| No Intervention: poseidon Group 4B & 3B<br>80 eligible infertile women fulfilling the criteria of Poseidon Group 4 (35 years or more and AMH <1.2ng/ml) will be randomized into Group 4A will receive controlled ovarian stimulation (COS) and growth hormone (GH) and Group 4B will receive COS only. Similarly, 80 eligible infertile women fulfilling the criteria of Poseidon Group 3 (less than 35 years and AMH <1.2ng/ml) will be randomized into Group 3A will receive COS and GH and Group 3B will receive COS only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate | calculated as the number of live births (defined as at least one live born after 28 weeks of gestation) divided by the total number of patients who performed pregnancy tests. | 28 gestational weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum E2 level | Serum Estradiol level on day of human chorionic gonadotropin (hCG) in pg. | 2-3 weeks | 
| Endometrial thickness | Endometrial thickness on day of hCG in mm | 2-3 weeks | 
| Fertilization rate | number of 2pn oocytes to the total number of injected oocytes | 1 day after oocyte retrieval | 
| Number of day 3 embryos | Total number of available embryos on day 3 after oocyte retrieval | 3 days after oocyte retrieval | 
| Clinical pregnancy rate | Calculated as the number of clinical pregnancies (defined as the presence of a gestational sac with positive heart beat detected by transvaginal ultrasound scan 2 weeks after positive pregnancy test) divided by the number of embryo transfer procedures | 2 weeks after positive pregnancy test | 
| Implantation rate | Calculated as the ratio of the number of gestational sacs detected by sonography to the total number of embryos transferred | 2 weeks after positive pregnancy test | 
| Miscarriage rate | The number fetal losses per clinical pregnancies | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Growth hormone, Poor responder, Poseidon group,, ICSI