Dehydroepiandrosterone Versus Growth Hormone in Women Undergoing ICSI With Expected Poor Ovarian Response
1 other identifier
interventional
210
1 country
2
Brief Summary
300 women with expected poor ovarian response (POR) undergoing in vitro fertilization or intra-cytoplasmic sperm injection (ICSI) will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Dehydroepiandrosterone (DHEA) 25 mg ( DHEA 25mg, Natrol , USA) t.d.s daily for 12 weeks before starting IVF/ICSI cycle and a placebo similar to growth hormone (GH) daily from day 6 of stimulation until the day of human chorionic gonadotrophin (hCG) trigger. Group 2 will receive an oral placebo t.d.s. daily for 12 weeks before ICSI in addition to GH (Somatotropin, Sedico, Egypt) 4 IU on day 6 of hMG stimulation in a daily dose of 2.5 mg subcutaneous (SC) until the day of hCG triggering. Patients included in the study will be subjected to full history taking and clinical examination. On the second day of menstruation serum FSH, LH, Prolactin and Oestradiol will be assessed and the antral follicular count (AFC) will be assessed using a vaginal ultrasound scan. AFC will be defined as the number of follicles measuring 3-10mm. All patients will have gonadotropin antagonist protocol with Human menopausal gonadotrophin (hMG) stimulation until the day of hCG administration. On the day of hCG administration, ovarian ultrasound scan will be performed using a transvaginal probe. Oocytes will be aspirated 34-36 hours after HCG administration. Oocytes will be fertilized and embryos will be transferred. Both groups will be compared regarding the proportion of ongoing pregnancy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2016
CompletedFirst Posted
Study publicly available on registry
April 13, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedJuly 6, 2016
July 1, 2016
10 months
April 8, 2016
July 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Ongoing pregnancy
ongoing pregnancy will be confirmed by the presence of fetal cardiac pulsations by a transvaginal ultrasound 12 weeks after embryo transfer.
12 weeks after embryo transfer
Secondary Outcomes (1)
Clinical pregnancy
5 weeks after embryo transfer
Study Arms (2)
DHEA
ACTIVE COMPARATORWomen will receive oral DHEA 25 mg t.d.s. 12 weeks before ICSI
Growth hormone
ACTIVE COMPARATORWomen will receive 4 IU of growth hormone on day 6 of hMG stimulation in a daily dose of 2.5 mg SC until the day of hCG triggering
Interventions
Women will receive 4 IU of growth hormone on day 6 of hMG stimulation in a daily dose of 2.5 mg SC until the day of hCG triggering
Women will receive an oral placebo similar to DHEA for 12 weeks before ICSI.
Women will receive a placebo injection similar to growth hormone daily from day 6 of hMG stimulation until the day of hCG triggering.
Eligibility Criteria
You may qualify if:
- women undergoing IVF/ICSI with POR according to the Bologna criteria
You may not qualify if:
- Body mass index \>35 Kg/m2.
- women with a single ovary.
- Allergy to DHEA.
- Diabetic women on insulin as insulin lowers DHEA levels and might reduce its effectiveness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (2)
Cairo University Hospitals
Cairo, Egypt
Dar AlTeb subfertility centre
Cairo, Egypt
Related Publications (4)
Kotb MM, Hassan AM, AwadAllah AM. Does dehydroepiandrosterone improve pregnancy rate in women undergoing IVF/ICSI with expected poor ovarian response according to the Bologna criteria? A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2016 May;200:11-5. doi: 10.1016/j.ejogrb.2016.02.009. Epub 2016 Feb 21.
PMID: 26963897BACKGROUNDBassiouny YA, Dakhly DMR, Bayoumi YA, Hashish NM. Does the addition of growth hormone to the in vitro fertilization/intracytoplasmic sperm injection antagonist protocol improve outcomes in poor responders? A randomized, controlled trial. Fertil Steril. 2016 Mar;105(3):697-702. doi: 10.1016/j.fertnstert.2015.11.026. Epub 2015 Dec 13.
PMID: 26690008BACKGROUNDDakhly DM, Bayoumi YA, Gad Allah SH. Which is the best IVF/ICSI protocol to be used in poor responders receiving growth hormone as an adjuvant treatment? A prospective randomized trial. Gynecol Endocrinol. 2016;32(2):116-9. doi: 10.3109/09513590.2015.1092136. Epub 2015 Sep 29.
PMID: 26416521BACKGROUNDBayoumi YA, Dakhly DM, Bassiouny YA, Hashish NM. Addition of growth hormone to the microflare stimulation protocol among women with poor ovarian response. Int J Gynaecol Obstet. 2015 Dec;131(3):305-8. doi: 10.1016/j.ijgo.2015.05.034. Epub 2015 Aug 23.
PMID: 26381201BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
AbdelGany M Hassan
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Gynecology and Obstetrics
Study Record Dates
First Submitted
April 8, 2016
First Posted
April 13, 2016
Study Start
June 1, 2016
Primary Completion
April 1, 2017
Last Updated
July 6, 2016
Record last verified: 2016-07