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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT02766764
• Date of registration: 06/05/2016
• Prospective Registration: Yes
• Primary sponsor: Cairo University
• Public title: Combined Dehydropeiandrosterone and Growth Hormone in Women With Expected Poor Ovarian Response Undergoing ICSI
• Scientific title: Evaluation of the Role of Combined Dehydropeiandrosterone and Growth Hormone in Women With Expected Poor Ovarian Response Undergoing ICSI: A Double Blind Placebo Controlled Study.
• Date of first enrolment: June 2016
• Target sample size: 230
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02766764
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Egypt

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: 43 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Subfertility

Intervention(s)

Drug: Placebo 1

Drug: DHEA

Drug: Growth hormone

Drug: Placebo 2

Primary Outcome(s)

Ongoing pregnancy [Time Frame: 12 weeks after embryo transfer]

Secondary ID(s)

DHEA 4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors