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

March 8, 2012 updated by: Fertility Specialists of Houston

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77054
        • Recruiting
        • Fertility Specialists of Houston
        • Contact:
        • Contact:
        • Sub-Investigator:
          • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • ART case

Exclusion Criteria:

  • age < 40
  • no pre-implantation genetic diagnosis procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of embryo sac in uterus under ultrasound
Time Frame: 5 weeks after embryo transfer
The competency of embryo is determined by its ability to implant into endometirum.
5 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The delivery outcome is the secondary outcome measured.
Time Frame: 10 months after embryo transfer
The live birth and the weight and length of baby is examined.
10 months after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fertility Specialists of Houston

Collaborators

Origio A/S

Investigators

  • Principal Investigator: George M Grunert, M.D., Obstetrical & Gynecological Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (Estimate)

March 9, 2012

Study Record Updates

Last Update Posted (Estimate)

March 9, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OGAFSH-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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