UnknownPhase 4

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

Egypt230 participantsStarted 2016-06

Plain-language 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.

Who can participate

Age range20 Years – 43 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women undergoing ICSI with expected poor ovarian response according to the Bologna criteria Exclusion Criteria: * Body mass index \>35 Kg/m2. * Women with a single ovary. * Allergy to DHEA or GH. * Diabetic women on insulin as insulin lowers DHEA levels and might reduce its effectiveness

What they're measuring

Ongoing pregnancy

Timeframe: 12 weeks after embryo transfer

Trial details

NCT IDNCT02766764

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12

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