Text Size

Dehydroepiandrosterone Supplementation for Poor Responder Patients During in Vitro Fertilization Treatment

This study has been completed.
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01145144
First received: May 3, 2010
Last updated: June 15, 2010
Last verified: June 2010
History of Changes
  Purpose

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


Condition Intervention
Ovarian Stimulation
 Drug: dehydroepiandrosterone crystalline fine powder

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Prasterone
U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • peak estradiol level. [ Designated as safety issue: No ]
  • number of retrieved oocytes. [ Designated as safety issue: Yes ]
  • Embryos that were graded as a top quality (according to the number of cells and percent of fragmentation) [ Designated as safety issue: Yes ]
  • number of embryos reserved for transfer. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pregnancy rate. [ Designated as safety issue: Yes ]
  • live birth rate. [ Designated as safety issue: Yes ]

Study Start Date: January 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DHEA supplementation
DHEA was added to induction of ovulation by recombinant FSH and recombinant LH, in IVF long protocol
 Drug: dehydroepiandrosterone crystalline fine powder
No Intervention: only induction of ovulation by same long protocol without DHEA

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • previous poor response to ovarian stimulation in IVF.

Exclusion Criteria:

  • patients over the age of 42
  • patients who received DHEA at any time.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145144

Locations
Israel
Meir Medical center IVF unit
kfar Saba, Israel
Meir Medical Center
Kfar Sava, Israel
Sponsors and Collaborators
Meir Medical Center
  More Information

No publications provided by Meir Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Adriam Shulman, IVF Unit Meir Medical Center
ClinicalTrials.gov Identifier: NCT01145144     History of Changes
Other Study ID Numbers: mmc07204-2006ctil
Study First Received: May 3, 2010
Last Updated: June 15, 2010
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
Dehydroepiandrosterone
DHEA
IVF outcome
long protocol IVF
poor-responder
 recombinant LH
embryo quality
pregnancy rate
live birth rate
poor response to ovarian stimulation

Additional relevant MeSH terms:
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013