Enhanced Assisted Reproductive Technology Pregnancy Rate by Prostacyclin Analog (Iloprost)
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|ClinicalTrials.gov Identifier: NCT01549171|
Recruitment Status : Unknown
Verified March 2012 by Fertility Specialists of Houston.
Recruitment status was: Recruiting
First Posted : March 9, 2012
Last Update Posted : March 9, 2012
|Condition or disease||Intervention/treatment|
|Pregnancy||Drug: Iloprost Other: normal saline|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Case Control|
|Official Title:||Pilot Study to Examine Iloprost Can Enhance Human Assisted Reproductive Technology Pregnancy Outcomes.|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||November 2011|
|Estimated Study Completion Date :||December 2013|
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.
- Presence of embryo sac in uterus under ultrasound [ Time Frame: 5 weeks after embryo transfer ]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 ]The live birth and the weight and length of baby is examined.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|