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Enhanced Assisted Reproductive Technology Pregnancy Rate by Prostacyclin Analog (Iloprost)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Fertility Specialists of Houston.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Origio A/S
Information provided by (Responsible Party):
Fertility Specialists of Houston
ClinicalTrials.gov Identifier:
NCT01549171
First received: March 6, 2012
Last updated: March 8, 2012
Last verified: March 2012

March 6, 2012
March 8, 2012
January 2010
November 2011   (final data collection date for primary outcome measure)
Presence of embryo sac in uterus under ultrasound [ Time Frame: 5 weeks after embryo transfer ] [ Designated as safety issue: Yes ]
The competency of embryo is determined by its ability to implant into endometirum.
Same as current
Complete list of historical versions of study NCT01549171 on ClinicalTrials.gov Archive Site
The delivery outcome is the secondary outcome measured. [ Time Frame: 10 months after embryo transfer ] [ Designated as safety issue: Yes ]
The live birth and the weight and length of baby is examined.
Same as current
Not Provided
Not Provided
 
Enhanced Assisted Reproductive Technology Pregnancy Rate by Prostacyclin Analog (Iloprost)
Pilot Study to Examine Iloprost Can Enhance Human Assisted Reproductive Technology Pregnancy Outcomes.

Human fallopian tube secretes high concentration of prostacyclin. Fallopian tube is the site for early embryo development. The effect of prostacyclin on human early embryo development is waiting to be clarified. The study hypothesis is prostacyclin can enhance early embryo development.

Huang et al, found that human fallopian tube expresses prostacyclin synthetase and cyclooxygenase. These enzyme systems synthesize abundant prostacyclin (PGI2). In the fallopian tube PGI2 causes smooth muscle relaxation, possibly facilitating tubal transport of gametes and embryos. Huang et al reported that addition of the PGI2 analogue Iloprost to embryo culture media significantly enhanced mouse embryo development to the blastocyst and complete hatched stages. The implantation and live birth rates of Iloprost cultured embryos were significantly better than non-Iloprost embryos in the mouse model. The mean weights of fetal mice were not significant different from control group. There was no teratogenic effect observed.

In a previously presented study, the investigators cultured donated frozen human zygotes in culture media with and without the addition of Iloprost. The Iloprost treated embryos showed significantly better growth rate and morphology, as determined by the size, and grading of the trophectoderm and inner cell mass.

Iloprost is FDA approved for the treatment of pulmonary hypertension. It has a significantly longer half-life than native PGI2. Iloprost is a class C pregnancy drug and has not been associated with teratogenic effects. This study intends to expand the usage of Iloprost to culture embryos.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

ART cases with age < 40 and without pre-implantation genetic diagnosis

Pregnancy
  • Drug: Iloprost
    supplement in culture medium during culture in the lab. The concentration is 1 uM.
    Other Name: Ilomedin
  • Other: normal saline
    Supplement with vehicle only no Iloprost.
  • Iloprost
    This is the study group with 1 uM Iloprost.
    Intervention: Drug: Iloprost
  • Control
    This is the control group with vehicle (normal saline) only.
    Intervention: Other: normal saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2013
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ART case

Exclusion Criteria:

  • age < 40
  • no pre-implantation genetic diagnosis procedure
Female
20 Years to 39 Years
No
United States
 
NCT01549171
OGAFSH-01
No
Fertility Specialists of Houston
Fertility Specialists of Houston
Origio A/S
Principal Investigator: George M Grunert, M.D. Obstetrical & Gynecological Associates
Fertility Specialists of Houston
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP