Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dehydroepiandrosterone Versus Growth Hormone in Women Undergoing ICSI With Expected Poor Ovarian Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02736591
Recruitment Status : Unknown
Verified July 2016 by AbdelGany Hassan, Cairo University.
Recruitment status was:  Recruiting
First Posted : April 13, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
AbdelGany Hassan, Cairo University

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.


Condition or disease Intervention/treatment Phase
Subfertility Drug: DHEA Drug: Growth Hormone-Releasing Hormone Drug: Placebo 1 Drug: Placebo 2 Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dehydroepiandrosterone Versus Growth Hormone in Women Undergoing ICSI With Expected Poor Ovarian Response
Study Start Date : June 2016
Estimated Primary Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Active Comparator: DHEA
Women will receive oral DHEA 25 mg t.d.s. 12 weeks before ICSI
Drug: DHEA
Women will receive oral DHEA 25 mg t.d.s. 12 weeks before ICSI.

Drug: 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.

Active Comparator: 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
Drug: 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

Drug: Placebo 1
Women will receive an oral placebo similar to DHEA for 12 weeks before ICSI.




Primary Outcome Measures :
  1. Ongoing pregnancy [ Time Frame: 12 weeks after embryo transfer ]
    ongoing pregnancy will be confirmed by the presence of fetal cardiac pulsations by a transvaginal ultrasound 12 weeks after embryo transfer.


Secondary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: 5 weeks after embryo transfer ]
    clinical pregnancy will be confirmed by the presence of an intrauterine gestational sac using a transvaginal ultrasound 5 weeks after embryo transfer.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women undergoing IVF/ICSI with POR according to the Bologna criteria

Exclusion Criteria:

  • 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

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): NCT02736591


Contacts
Layout table for location contacts
Contact: AbdelGany M Hassan, MRCOG, MD +201017801604 abdelgany2@gmail.com

Locations
Layout table for location information
Egypt
Cairo University Hospitals Recruiting
Cairo, Egypt
Contact: AbdelGany MA Hassan, MRCOG, MD    00217801604    abdelgany2@gmail.com   
Principal Investigator: AbdelGany MA Hassan, MRCOG, MD         
Dar AlTeb subfertility centre Recruiting
Cairo, Egypt
Contact: AbdelGany MA Hassan, MRCOG, MD    00217801604    abdelgany2@gmail.com   
Principal Investigator: AbdelGany MA Hassan, MRCOG, MD         
Sub-Investigator: Mohamed MM Kotb, MD         
Sub-Investigator: Ahmed MA AwadAllah, MD         
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Principal Investigator: AbdelGany M Hassan Cairo University

Publications:
Layout table for additonal information
Responsible Party: AbdelGany Hassan, Lecturer of Gynecology and Obstetrics, Cairo University
ClinicalTrials.gov Identifier: NCT02736591     History of Changes
Other Study ID Numbers: sub 13
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Growth Hormone-Releasing Hormone
Dehydroepiandrosterone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors