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Clinical Trials/NCT01549171
NCT01549171UnknownNot Applicable

Pilot Study to Examine Iloprost Can Enhance Human Assisted Reproductive Technology Pregnancy Outcomes.

Fertility Specialists of Houston1 site in 1 country100 target enrollmentStarted: January 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Presence of embryo sac in uterus under ultrasound

Study Overview

Brief 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.

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 39 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Arms & Interventions

Iloprost

This is the study group with 1 uM Iloprost.

Intervention: Iloprost (Drug)

Control

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

Intervention: normal saline (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • The delivery outcome is the secondary outcome measured.(10 months after embryo transfer)

Investigators

Sponsor
Fertility Specialists of Houston
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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