NCT03373149

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Riyadh Fertility and Reproductive Health center · Academic / Other
• Sex: Female
• Age: 35 Years – 42 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility, Female

Interventions

Type	Name	Description
DRUG	Growth 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.
DRUG	HPuFSH/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.

Timeline

• Start date: 2017-11-29
• Primary completion: 2020-07-01
• Completion: 2020-11-01
• First posted: 2017-12-14
• Last updated: 2020-05-27

Locations

1 site across 1 country: Egypt