Female Infertility
Conditions
Keywords
Growth hormone, Poor responder, Poseidon group,, ICSI
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).
Interventions
DRUGGrowth Hormone
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
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Infertile women aged 20-45 years. 2. AFC \<5. 3. AMH level \<1.2 ng/ml. 4. Have two normal ovaries and normal uterine cavity.
Exclusion criteria
1. Body mass index (BMI) \>30 kg/m2. 2. Follicle Stimulating Hormone (FSH) \> 15 IU/L. 3. History of abnormal karyotype in one or both partners. 4. Endocrine, metabolic or autoimmune disorders, such as diabetes, thyroid disorder, and polycystic ovary syndrome (PCOS). 5. Women with a known medical disease (e.g. severe hypertension or hepatic disease). 6. Endometriosis. 7. Previous ovarian surgery. 8. Current or history of malignancies, chemotherapy or radiotherapy. 9. Severe male actor (total motile sperm count \<1×106 or normal morphology \<1%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live birth rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Serum E2 level | 2-3 weeks | Serum Estradiol level on day of human chorionic gonadotropin (hCG) in pg. |
| Endometrial thickness | 2-3 weeks | Endometrial thickness on day of hCG in mm |
| Fertilization rate | 1 day after oocyte retrieval | number of 2pn oocytes to the total number of injected oocytes |
| Miscarriage rate | 20 weeks | The number fetal losses per clinical pregnancies |
| Clinical pregnancy rate | 2 weeks after positive pregnancy test | 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 |
| Implantation rate | 2 weeks after positive pregnancy test | Calculated as the ratio of the number of gestational sacs detected by sonography to the total number of embryos transferred |
| Number of day 3 embryos | 3 days after oocyte retrieval | Total number of available embryos on day 3 after oocyte retrieval |
Countries
Egypt
Outcome results
None listed