Does Dehydro Epiandrosterone (DHEA) Improve Pregnancy Rate in Women Undergoing IVF/ICSI With Expected Poor Ovarian Response?
Condition: Subfertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): DHEA
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DHEA; IVF; ICSI