Clinical trial NCT01549171: Enhanced Assisted Reproductive Technology Pregnancy Rate by Prostacyclin Analog (Iloprost)
Official title: Pilot Study to Examine Iloprost Can Enhance Human Assisted Reproductive Technology Pregnancy Outcomes.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: Human ART
Prostacyclin
Iloprost
Pregnancy
Lead sponsor: Fertility Specialists of Houston
Sponsor class: OTHER
Collaborators: name: Origio A/S
First posted: 2012-03-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ART cases with age \< 40 and without pre-implantation genetic diagnosis

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.

Eligibility criteria: Inclusion Criteria:

* ART case

Exclusion Criteria:

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

Primary outcomes:
measure: Presence of embryo sac in uterus under ultrasound
timeFrame: 5 weeks after embryo transfer
Secondary outcomes:
measure: The delivery outcome is the secondary outcome measured.
timeFrame: 10 months after embryo transfer
Other outcomes:
Locations:
city: Houston
country: United States
facility: Fertility Specialists of Houston
state: Texas
Study officials:
affiliation: Obstetrical & Gynecological Associates
name: George M Grunert, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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
citation: 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.
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. doi: 10.1093/humrep/deh524. Epub 2004 Oct 15.
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. doi: 10.1093/humrep/deh352. Epub 2004 Jun 17.