Infertility, Female
Conditions
Keywords
IVF, Growth hormone, Poor responders
Brief summary
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
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.
Interventions
DRUGGrowth hormone/HPuFSH/GnRH antagonist
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.
DRUGHPuFSH/GnRH antagonist
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.
Sponsors
Riyadh Fertility and Reproductive Health center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* Serum anti-Müllerian hormone (AMH) less than 1.2 ng/ml
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of participants who achieved a clinical pregnancy in a transfer cycle | Five weeks after embryo transfer |
Secondary
| Measure | Time frame |
|---|---|
| The number of participants who achieved a ongoing pregnancy in a transfer cycle | Eighteen weeks after embryo transfer |
Countries
Egypt
Contacts
Primary ContactUsama M Fouda, Prof.
Outcome results
None listed