drugset / Trial / NCT02766764

Combined Dehydropeiandrosterone and Growth Hormone in Women With Expected Poor Ovarian Response Undergoing ICSI

NCT02766764

Phase 4 Unknown 230 enrolled Cairo University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Two hundred and thirty women with expected poor ovarian response undergoing IVF/ICSI will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive DHEA 25 mg (DHEA 25mg, Natrol , USA) t.d.s for 12 weeks before starting IVF/ICSI cycle in addition to Growth hormone (GH; Somatotropin, Sedico, Egypt) 4 IU on day 6 of human menopausal gonadotropin (hMG) stimulation in a daily dose of 2.5 mg subcutaneous (sc) until the day of human chorionic gonadotropin (hCG) triggering Group 2 will receive an oral placebo t.d.s. daily for 12 weeks before ICSI in addition to a sc placebo similar to GH daily from day 6 of stimulation until the day of hCG trigger.

Timeline

Start
2016-06
Primary completion
2018-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator DHEA Unknown 25 mg Oral
Comparator Somatropin Protein / enzyme biologic 2.5 mg Subcutaneous

Indications