Dehydroepiandrosterone Versus Growth Hormone in Women Undergoing ICSI With Expected Poor Ovarian Response
NCT ID: NCT02736591
Last Updated: 2016-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
210 participants
INTERVENTIONAL
2016-06-30
Brief Summary
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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.
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Detailed Description
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300 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 daily for 12 weeks before starting IVF/ICSI cycle and a placebo similar to GH daily from day 6 of stimulation until the day of hCG trigger. Group 2 will receive an oral placebo t.d.s. daily for 12 weeks before ICSI in addition to GH Growth hormone (Somatotropin, Sedico, Egypt) 4 IU on day 6 of hMG stimulation in a daily dose of 2.5 mg 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 (Human chorionic gonadotrophin (HCG) administration. 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.
The stimulation protocol will start on day 2 using 450-300 IU HMG ( Merional® IBSA, Lugano, Switzerland) and gonadotrophin releasing hormone antagonist, cetrorelix (Cetrotide® Merck Serono, Darmstadt, Germany) 0.025 mg daily. Gonadotropins will be administered for 4 to 5 days, after which the dose will be adjusted according to the ovarian response. The ovarian response will be monitored by transvaginal ultrasound and serum E2 levels. When three or more follicles reached a maximum diameter of 16 mm, highly purified HCG 5000 or 10,000 IU (Choriomon ®IBSA) will be administered. The procedure will be cancelled if less than 3 follicles 16 mm in size are present 12 days after starting gonadotropins despite doses reaching 450 IU. The cycle will be also cancelled if there is risk of ovarian hyperstimulation like massive ovarian enlargement or serum estradiol exceeds 3000pg/L Transvaginal oocyte retrieval will be performed 34-36 h after the administration of HCG. Oocytes will be fertilized either via IVF or ICSI based on the couple's history. Fertilization will be assessed 16-18 h after IVF or ICSI . Embryos will be transferred on Day 3 or 5. Vaginal tablets containing progesterone (Prontogest® IBSA) 400 mg/day will be given when fertilization is confirmed. A pregnancy test will be done 2 weeks after embryo transfer. For patients with a positive pregnancy test, progesterone is to be continued for an additional 4 weeks. Clinical pregnancy will be defined as Visualization of an intrauterine gestational sac 5 weeks after embryo transfer. And ongoing pregnancy will be defined as the sonographic confirmation of fetal heart pulsations at 12 weeks.
Sample size calculation:
Investigators are planning a study of independent cases and controls with 1 control(s) per case. Kotb et al found that the ongoing pregnancy rate in women undergoing IVF/ICSI with expected POR according to the Bologna controls is 0.285. On the other hand Bassiouny et al found that the ongoing pregnancy rate in women undergoing ICSI with expected POR who received growth hormone is 0.147, investigators will need to study 138 case patients who will receive DHEA and 138 patients who will receive GH to be able to reject the null hypothesis that the ongoing pregnancy rates for DHEA and GH are equal with probability (power) 0.8. Investigators will add 12 patients to each arm to account for missing data and dropout patients. The Type I error probability associated with this test of this null hypothesis is 0.05. Investigators will use an uncorrected chi-squared statistic to evaluate this null hypothesis.
The primary outcome will be the ongoing pregnancy rate defined as sonographic confirmation of fetal heart beat at 12 weeks of gestation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DHEA
Women will receive oral DHEA 25 mg t.d.s. 12 weeks before ICSI
DHEA
Women will receive oral DHEA 25 mg t.d.s. 12 weeks before ICSI.
Placebo 2
Women will receive a placebo injection similar to growth hormone daily from day 6 of hMG stimulation until the day of hCG triggering.
Growth hormone
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
Growth Hormone-Releasing Hormone
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
Placebo 1
Women will receive an oral placebo similar to DHEA for 12 weeks before ICSI.
Interventions
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DHEA
Women will receive oral DHEA 25 mg t.d.s. 12 weeks before ICSI.
Growth Hormone-Releasing Hormone
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
Placebo 1
Women will receive an oral placebo similar to DHEA for 12 weeks before ICSI.
Placebo 2
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
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Inclusion Criteria
Exclusion Criteria
* women with a single ovary.
* Allergy to DHEA.
* Diabetic women on insulin as insulin lowers DHEA levels and might reduce its effectiveness
20 Years
43 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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AbdelGany Hassan
Lecturer of Gynecology and Obstetrics
Principal Investigators
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AbdelGany M Hassan
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Cairo University Hospitals
Cairo, , Egypt
Dar AlTeb subfertility centre
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Bassiouny 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.
Dakhly 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.
Bayoumi 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.
Other Identifiers
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sub 13
Identifier Type: -
Identifier Source: org_study_id
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