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

NCT02151006 | Completed Phase 3 DMC

• 1 other identifier: Sub 2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Subfertility

Keywords

DHEA; IVF; ICSI

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy

  Sonographic detection of a gestational sac

  5 weeks after embryo transfer

Secondary Outcomes (3)

• Number of oocytes retrieved

  one hour after ovum pick up

• Number of formed embryos

  3 days after ovum pick up

• Quality of formed embryos

  3 days after ovum pick up

Study Arms (2)

DHEA

ACTIVE COMPARATOR

women will receive DHEA 6 weeks before starting IVF/ICSI

Drug: DHEA

Control

NO INTERVENTION

Interventions

DHEA DRUG

DHEA

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Cairo University Hospitals

Cairo, Egypt

Location

Dar AlTeb subfertility centre

Giza, Egypt

Location

Related Publications (5)

• Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.

  PMID: 21505041 BACKGROUND

• Barad D, Brill H, Gleicher N. Update on the use of dehydroepiandrosterone supplementation among women with diminished ovarian function. J Assist Reprod Genet. 2007 Dec;24(12):629-34. doi: 10.1007/s10815-007-9178-x. Epub 2007 Dec 11.

  PMID: 18071895 BACKGROUND

• Casson PR, Lindsay MS, Pisarska MD, Carson SA, Buster JE. Dehydroepiandrosterone supplementation augments ovarian stimulation in poor responders: a case series. Hum Reprod. 2000 Oct;15(10):2129-32. doi: 10.1093/humrep/15.10.2129.

  PMID: 11006185 BACKGROUND

• Gleicher N, Weghofer A, Barad DH. The role of androgens in follicle maturation and ovulation induction: friend or foe of infertility treatment? Reprod Biol Endocrinol. 2011 Aug 17;9:116. doi: 10.1186/1477-7827-9-116.

  PMID: 21849061 BACKGROUND

• 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.

  PMID: 26963897 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Mohamed MM Kotb, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

EG (2)