Effect of Growth Hormone Administration With Controlled Ovarian Stimulation in Expected Poor Responders POSEIDON Group 3 and 4 Undergoing ICSI Using Antagonist Protocol
Overview
- Phase
- Phase 4
- Intervention
- Growth Hormone
- Conditions
- Female Infertility
- Sponsor
- Alexandria University
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Live birth rate
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infertile women aged 20-45 years.
- •AMH level \<1.2 ng/ml.
- •Have two normal ovaries and normal uterine cavity.
Exclusion Criteria
- •Body mass index (BMI) \>30 kg/m
- •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%)
Arms & Interventions
Poseidon Group 4A & 3A
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.
Intervention: Growth Hormone
Outcomes
Primary Outcomes
Live birth rate
Time Frame: 28 gestational weeks
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.
Secondary Outcomes
- Serum E2 level(2-3 weeks)
- Endometrial thickness(2-3 weeks)
- Fertilization rate(1 day after oocyte retrieval)
- Number of day 3 embryos(3 days after oocyte retrieval)
- Clinical pregnancy rate(2 weeks after positive pregnancy test)
- Implantation rate(2 weeks after positive pregnancy test)
- Miscarriage rate(20 weeks)