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Status unknownNCT01549171Updated Mar 9, 2012

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

An observational study in Pregnancy, sponsored by Fertility Specialists of Houston. Status unknown at 1 site in United States. Open to female participants aged 20 Years to 39 Years. Per ClinicalTrials.gov, last updated 2012-03-09.

Sponsored by Fertility Specialists of Houston · Observational

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
20 Years to 39 Years
Sex
Female
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Pregnancy

Keywords

  • Human ART
  • Prostacyclin
  • Iloprost
  • Pregnancy
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In context

Lead sponsor

This is the only study on the registry with Fertility Specialists of Houston as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • ART case

Exclusion criteria

Exclusion Criteria:

  • age \< 40
  • no pre-implantation genetic diagnosis procedure
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)

Groups and cohorts

  • Iloprost

    This is the study group with 1 uM Iloprost.

    Drug: Iloprost

  • Control

    This is the control group with vehicle (normal saline) only.

    Other: normal saline

Interventions

  • DrugIloprost

    supplement in culture medium during culture in the lab. The concentration is 1 uM.

    Also known as: Ilomedin

  • Othernormal saline

    Supplement with vehicle only no Iloprost.

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What researchers measure

Primary outcomes

  1. Presence of embryo sac in uterus under ultrasound

    The competency of embryo is determined by its ability to implant into endometirum.

    Time frame: 5 weeks after embryo transfer

Secondary outcomes

  1. The delivery outcome is the secondary outcome measured.

    The live birth and the weight and length of baby is examined.

    Time frame: 10 months after embryo transfer

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Study locations

1 of 1 sites recruiting
  • Fertility Specialists of Houston
    Houston, Texas 77054, United States
    • Wan-Song A Wun, Ph.D. · Contact · awun@obgynassociates.com · 713-512-7680
    • George M Grunert, M.D. · Contact · ggrunert@fshivf.com · 713-512-7760
    • Randall C Dunn, M.D. · Sub investigator
    • Schenk M Leah, M.D. · Sub investigator
    • Mangal K Rakesh, M.D. · Sub investigator
    • Chauhan R Subodh, M.D. · Sub investigator
    • Wan-Song A Wun, Ph.D. · Sub investigator
    Recruiting
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References and documents

Publications

  • Battenfeld R, Schuh W, Schobel C. Studies on reproductive toxicity of iloprost in rats, rabbits and monkeys. Toxicol Lett. 1995 Aug;78(3):223-34. doi: 10.1016/0378-4274(95)03323-d. PubMed 7542807 ↗
  • Grunert GM, Dunn RC, Valdes CT, Schenk LM, Mangal RK, Wun WSA: Prostacyclin agonist (Iloprost) enhances human embryo development. Fertility and Sterility 84:S237, 2005
  • Huang JC, Arbab F, Tumbusch KJ, Goldsby JS, Matijevic-Aleksic N, Wu KK. Human fallopian tubes express prostacyclin (PGI) synthase and cyclooxygenases and synthesize abundant PGI. J Clin Endocrinol Metab. 2002 Sep;87(9):4361-8. doi: 10.1210/jc.2002-020199. PubMed 12213900 ↗
  • Huang JC, Wun WS, Goldsby JS, Matijevic-Aleksic N, Wu KK. Cyclooxygenase-2-derived endogenous prostacyclin enhances mouse embryo hatching. Hum Reprod. 2004 Dec;19(12):2900-6. doi: 10.1093/humrep/deh524. Epub 2004 Oct 15. PubMed 15489241 ↗
  • Huang JC, Goldsby JS, Wun WS. Prostacyclin enhances the implantation and live birth potentials of mouse embryos. Hum Reprod. 2004 Aug;19(8):1856-60. doi: 10.1093/humrep/deh352. Epub 2004 Jun 17. PubMed 15205402 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01549171
Lead sponsor
Fertility Specialists of Houston
Collaborators
Origio A/S
Responsible party
Sponsor
First posted
Mar 9, 2012
Start date
Jan 2010
Primary completion
Nov 2011
Completion
Dec 2013 (estimated)
Last update
Mar 9, 2012

Study contacts

George M Grunert, M.D.
principal investigator · Obstetrical & Gynecological Associates

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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