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

• Conditions: Pregnancy
• Interventions: Drug: Iloprost; Other: normal saline

• Registration Number: NCT01549171
• Lead Sponsor: Fertility Specialists of Houston

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 Timeline

• Study Start: 2010-01
• Primary Completion: 2011-11
• Status Verified: 2012-03
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-08
• Last Update Submitted: 2012-03-08
• Study First Posted: 2012-03-09
• Last Update Posted: 2012-03-09
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• ART case

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Iloprost	Iloprost	This is the study group with 1 uM Iloprost.
Control	normal saline	This is the control group with vehicle (normal saline) only.

Primary Outcome Measures

Name	Time	Method
Presence of embryo sac in uterus under ultrasound	5 weeks after embryo transfer	The competency of embryo is determined by its ability to implant into endometirum.

Secondary Outcome Measures

Name	Time	Method
The delivery outcome is the secondary outcome measured.	10 months after embryo transfer	The live birth and the weight and length of baby is examined.

Trial Locations

Locations (1)

Fertility Specialists of Houston; 🇺🇸 Houston, Texas, United States