NCT01145144

Brief Summary

The aim of this study was to evaluate the effect of dehydroepiandrosterone supplementation on in vitro fertilization performance and outcome among poor-responder patient.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 16, 2010

Completed
Last Updated

June 16, 2010

Status Verified

June 1, 2010

Enrollment Period

1.5 years

First QC Date

May 3, 2010

Last Update Submit

June 15, 2010

Conditions

Ovarian Stimulation

Keywords

DehydroepiandrosteroneDHEAIVF outcomelong protocol IVFpoor-responderrecombinant LHembryo qualitypregnancy ratelive birth ratepoor response to ovarian stimulation

Outcome Measures

Primary Outcomes (4)

  • peak estradiol level.

  • number of retrieved oocytes.

  • Embryos that were graded as a top quality (according to the number of cells and percent of fragmentation)

  • number of embryos reserved for transfer.

Secondary Outcomes (2)

  • pregnancy rate.

  • live birth rate.

Study Arms (2)

DHEA supplementation

EXPERIMENTAL

DHEA was added to induction of ovulation by recombinant FSH and recombinant LH, in IVF long protocol

Drug: dehydroepiandrosterone crystalline fine powder

only induction of ovulation by same long protocol without DHEA

NO INTERVENTION

Interventions

dehydroepiandrosterone crystalline fine powderDRUG
DHEA supplementation

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • previous poor response to ovarian stimulation in IVF.

You may not qualify if:

  • patients over the age of 42
  • patients who received DHEA at any time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Meir Medical center IVF unit

Kfar Saba, Kfar Saba, Israel

Location

Meir Medical Center

Kfar Saba, Kfar Sava, Israel

Location

Related Publications (1)

  • Wiser A, Gonen O, Ghetler Y, Shavit T, Berkovitz A, Shulman A. Addition of dehydroepiandrosterone (DHEA) for poor-responder patients before and during IVF treatment improves the pregnancy rate: a randomized prospective study. Hum Reprod. 2010 Oct;25(10):2496-500. doi: 10.1093/humrep/deq220. Epub 2010 Aug 21.

    PMID: 20729538DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2010

First Posted

June 16, 2010

Study Start

January 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

June 16, 2010

Record last verified: 2010-06

Locations

IL(2)