Enhanced Assisted Reproductive Technology Pregnancy Rate by Prostacyclin Analog (Iloprost)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pregnancy |
Drug: Iloprost Other: normal saline |
| Study Type: | Observational |
| 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.
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Iloprost
This is the study group with 1 uM Iloprost.
|
Drug: Iloprost
supplement in culture medium during culture in the lab. The concentration is 1 uM.
Other Name: Ilomedin
|
|
Control
This is the control group with vehicle (normal saline) only.
|
Other: normal saline
Supplement with vehicle only no Iloprost.
|
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| Ages Eligible for Study: | 20 Years to 39 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
ART cases with age < 40 and without pre-implantation genetic diagnosis
Inclusion Criteria:
- ART case
Exclusion Criteria:
- age < 40
- no pre-implantation genetic diagnosis procedure
Contacts and Locations| United States, Texas | |
| Fertility Specialists of Houston | Recruiting |
| Houston, Texas, United States, 77054 | |
| Contact: Wan-Song A Wun, Ph.D. 713-512-7680 awun@obgynassociates.com | |
| Contact: George M Grunert, M.D. 713-512-7760 ggrunert@fshivf.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 |
More Information
Publications:
| Responsible Party: | Fertility Specialists of Houston |
| ClinicalTrials.gov Identifier: | NCT01549171 History of Changes |
| Other Study ID Numbers: | OGAFSH-01 |
| Study First Received: | March 6, 2012 |
| Last Updated: | March 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Fertility Specialists of Houston:
|
Human ART Prostacyclin Iloprost Pregnancy |
Additional relevant MeSH terms:
|
Epoprostenol Iloprost Tezosentan Platelet Aggregation Inhibitors Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on May 22, 2013