Subfertility Clinical Trial
Official title:
Does DHEA Improve Pregnancy Rate in Women Undergoing IVF/ICSI With Expected Poor Ovarian Response According to the Bologna Criteria? A Randomized Controlled Study
140 women with expected poor ovarian response undergoing IVF/ICSI will be randomly divided
into 2 groups using computer generated random numbers . Group 1 ( study group) will receive
DHEA 25 mg ( DHEA 25mg, Natrol , USA) t.d.s daily for 12 weeks before starting IVF/ICSI
cycle. Group 2 ( control group) will not receive DHEA. 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 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 pregnancy.
The study will be conducted in Cairo university hospitals and Dar Al-Teb Infertility and
Assisted conception center, Giza Egypt. All patients attending the centre will be evaluated
for their expected ovarian response.Patients fulfilling the Bologna criteria definition of
poor ovarian response will be invited to participate in the study and to sign informed
consent forms. The invitation will include a clear full explanation of the study.
140 women will be randomly divided into 2 groups using computer generated random numbers.
Group 1 ( study group) will include 70 women who will receive DHEA 25 mg t.d.s ( DHEA®,
Natrol , USA) twice daily for 12 weeks before starting IVF/ICSI cycle. Group 2 will include
70 women who will not receive DHEA and will serve as the control group. All women fulfilling
the inclusion criteria will be invited to participate in the study. A written informed
consent will be taken and only women signing the consent will be included in the study.
Patients included in the study will be subjected to full history taking and clinical
examination including general, abdominal and gynecological examination. This will be
followed by a vaginal ultrasound scan to assess uterus, ovaries and any pelvic masses.
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 GnRH 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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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