NCT02561793

Brief Summary

440 women with expected poor ovarian response undergoing IVF/ICSI (intracytoplasmic sperm injection) will be randomly divided into 2 groups using computer generated random numbers . Group 1 ( study group) will receive Dehydroepiandrosterone (DHEA) 25 mg ( DHEA 25mg, Natrol , USA) t.d.s daily for 12 weeks before starting IVF/ICSI cycle. Group 2 ( control group) will receive a placebo. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
440

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

1.9 years

First QC Date

September 25, 2015

Last Update Submit

July 3, 2016

Conditions

Subfertility

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    Ongoing pregnancy will be confirmed by a transvaginal scan confirming the presence of an embryo with evidence of heart beats.

    12 weeks after embryo transfer

Secondary Outcomes (1)

  • Clinical pregnancy rate

    5 weeks after embryo transfer

Study Arms (2)

DHEA

ACTIVE COMPARATOR

Women will receive DHEA 12 weeks before starting IVF/ICSI

Drug: DHEA

Placebo

PLACEBO COMPARATOR

Women will receive a placebo 12 weeks before starting IVF/ICSI

Drug: Placebo

Interventions

DHEADRUG

Women will receive DHEA 12 weeks before starting IVF/ICSI

DHEA
PlaceboDRUG

women will receive a placebo 12 weeks before starting IVF/ICSI

Placebo

Eligibility Criteria

Age20 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo University Hospitals

Cairo, Egypt

RECRUITING

Dar AlTeb subfertility centre

Giza, Egypt

RECRUITING

Related Publications (3)

  • Jirge PR, Chougule SM, Gavali VG, Bhomkar DA. Impact of dehydroepiandrosterone on clinical outcome in poor responders: A pilot study in women undergoing in vitro fertilization, using bologna criteria. J Hum Reprod Sci. 2014 Jul;7(3):175-80. doi: 10.4103/0974-1208.142477.

    PMID: 25395742BACKGROUND

  • Xu B, Li Z, Yue J, Jin L, Li Y, Ai J, Zhang H, Zhu G. Effect of dehydroepiandrosterone administration in patients with poor ovarian response according to the Bologna criteria. PLoS One. 2014 Jun 16;9(6):e99858. doi: 10.1371/journal.pone.0099858. eCollection 2014.

    PMID: 24932478BACKGROUND

  • Spremovic-Radjenovic S, Bila J, Gudovic A, Vidakovic S, Dokic M, Radunovic N. [Poor Ovarian Response to Stimulation for In Vitro Fertilization]. Srp Arh Celok Lek. 2015 May-Jun;143(5-6):354-61. doi: 10.2298/sarh1506354s. Serbian.

    PMID: 26259413BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-KetosteroidsKetosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Gynecology and Obstetrics

Study Record Dates

First Submitted

September 25, 2015

First Posted

September 28, 2015

Study Start

October 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

July 6, 2016

Record last verified: 2016-07

Locations

EG(2)