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

NCT01549171 | Unknown

• 1 other identifier: OGAFSH-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Human ART; Prostacyclin; Iloprost; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The delivery outcome is the secondary outcome measured.

  10 months after embryo transfer

Study Arms (2)

Iloprost

This is the study group with 1 uM Iloprost.

Drug: Iloprost

Control

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

Other: normal saline

Interventions

Iloprost DRUG

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

Also known as: Ilomedin

Iloprost

normal saline OTHER

Supplement with vehicle only no Iloprost.

Control

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• ART case

You may not qualify if:

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

Sponsors & Collaborators

• Fertility Specialists of Houston: lead
• Origio A/S: collaborator

Study Sites (1)

Fertility Specialists of Houston

Houston, Texas, 77054, United States

RECRUITING

Related Publications (5)

• Battenfeld R, Schuh W, Schobel C. Studies on reproductive toxicity of iloprost in rats, rabbits and monkeys. Toxicol Lett. 1995 Aug;78(3):223-34. doi: 10.1016/0378-4274(95)03323-d.

  PMID: 7542807 BACKGROUND

• 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

  BACKGROUND

• 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. doi: 10.1210/jc.2002-020199.

  PMID: 12213900 BACKGROUND

• 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. doi: 10.1093/humrep/deh524. Epub 2004 Oct 15.

  PMID: 15489241 BACKGROUND

• 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. doi: 10.1093/humrep/deh352. Epub 2004 Jun 17.

  PMID: 15205402 BACKGROUND

MeSH Terms

Interventions

Iloprost; Saline Solution

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• George M Grunert, M.D.

  Obstetrical & Gynecological Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 9, 2012
• Study Start: January 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2013
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

US (1)