Enhanced Assisted Reproductive Technology Pregnancy Rate by Prostacyclin Analog (Iloprost)
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Pilot Study to Examine Iloprost Can Enhance Human Assisted Reproductive Technology Pregnancy Outcomes.|
- Presence of embryo sac in uterus under ultrasound [ Time Frame: 5 weeks after embryo transfer ] [ Designated as safety issue: Yes ]The competency of embryo is determined by its ability to implant into endometirum.
- The delivery outcome is the secondary outcome measured. [ Time Frame: 10 months after embryo transfer ] [ Designated as safety issue: Yes ]The live birth and the weight and length of baby is examined.
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
This is the study group with 1 uM Iloprost.
supplement in culture medium during culture in the lab. The concentration is 1 uM.
Other Name: Ilomedin
This is the control group with vehicle (normal saline) only.
Other: normal saline
Supplement with vehicle only no Iloprost.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549171
|United States, Texas|
|Fertility Specialists of Houston||Recruiting|
|Houston, Texas, United States, 77054|
|Contact: Wan-Song A Wun, Ph.D. 713-512-7680 firstname.lastname@example.org|
|Contact: George M Grunert, M.D. 713-512-7760 email@example.com|
|Sub-Investigator: Randall C Dunn, M.D.|
|Sub-Investigator: Schenk M Leah, M.D.|
|Sub-Investigator: Mangal K Rakesh, M.D.|
|Sub-Investigator: Chauhan R Subodh, M.D.|
|Sub-Investigator: Wan-Song A Wun, Ph.D.|
|Principal Investigator:||George M Grunert, M.D.||Obstetrical & Gynecological Associates|