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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01549171
Enrollment
100
Registered
2012-03-09
Start date
2010-01-31
Completion date
2013-12-31
Last updated
2012-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Human ART, Prostacyclin, Iloprost, Pregnancy

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.

Interventions

DRUGIloprost

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

OTHERnormal saline

Supplement with vehicle only no Iloprost.

Sponsors

Origio A/S
CollaboratorINDUSTRY
Fertility Specialists of Houston
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 39 Years
Healthy volunteers
No

Inclusion criteria

* ART case

Exclusion criteria

* age \< 40 * no pre-implantation genetic diagnosis procedure

Design outcomes

Primary

MeasureTime frameDescription
Presence of embryo sac in uterus under ultrasound5 weeks after embryo transferThe competency of embryo is determined by its ability to implant into endometirum.

Secondary

MeasureTime frameDescription
The delivery outcome is the secondary outcome measured.10 months after embryo transferThe live birth and the weight and length of baby is examined.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026