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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01549171
• Other study ID #: OGAFSH-01
• Status: Unknown status
• Phase: N/A
• First received: March 6, 2012
• Last updated: March 8, 2012
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: March 2012
• Source: Fertility Specialists of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

Inclusion Criteria:

• ART case

Exclusion Criteria:

• age < 40

• no pre-implantation genetic diagnosis procedure

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• Iloprost
supplement in culture medium during culture in the lab. The concentration is 1 uM.

Other:
• normal saline
Supplement with vehicle only no Iloprost.

Locations

Country	Name	City	State
United States	Fertility Specialists of Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Fertility Specialists of Houston	Origio A/S

Country where clinical trial is conducted

United States, 

References & Publications (5)

Battenfeld R, Schuh W, Schöbel C. Studies on reproductive toxicity of iloprost in rats, rabbits and monkeys. Toxicol Lett. 1995 Aug;78(3):223-34. — View Citation

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. — View Citation

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. Epub 2004 Jun 17. — View Citation

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. Epub 2004 Oct 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of embryo sac in uterus under ultrasound	The competency of embryo is determined by its ability to implant into endometirum.	5 weeks after embryo transfer
Secondary	The delivery outcome is the secondary outcome measured.	The live birth and the weight and length of baby is examined.	10 months after embryo transfer