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Trial record 76 of 236 for:    PRASTERONE

Does Dehydro Epiandrosterone (DHEA) Improve Pregnancy Rate in Women Undergoing IVF/ICSI With Expected Poor Ovarian Response?

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ClinicalTrials.gov Identifier: NCT02151006
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : May 19, 2015
Sponsor:
Information provided by (Responsible Party):
AbdelGany Hassan, Cairo University

Brief 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.


Condition or disease Intervention/treatment Phase
Subfertility Drug: DHEA Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Active Comparator: DHEA
women will receive DHEA 6 weeks before starting IVF/ICSI
Drug: DHEA
No Intervention: Control



Primary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: 5 weeks after embryo transfer ]
    Sonographic detection of a gestational sac


Secondary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: one hour after ovum pick up ]
  2. Number of formed embryos [ Time Frame: 3 days after ovum pick up ]
  3. Quality of formed embryos [ Time Frame: 3 days after ovum pick up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women undergoing IVF/ICSI treatment with expected poor ovarian response according to the Bologna criteria

Exclusion Criteria:

  • Women with BMI >35 Kg/M2
  • Women with a single ovary
  • Known allergy to DHEA
  • Diabetic women on insulin as insulin lowers DHEA levels and might reduce the effectiveness of DHEA supplements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151006


Locations
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Egypt
Cairo University Hospitals
Cairo, Egypt
Dar AlTeb subfertility centre
Giza, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Mohamed MM Kotb, MD Cairo University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbdelGany Hassan, Lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT02151006     History of Changes
Other Study ID Numbers: Sub 2
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: May 2015
Keywords provided by AbdelGany Hassan, Cairo University:
DHEA
IVF
ICSI
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs