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

Study Overview
=================
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.

Official Title
-----------------
Pilot Study to Examine Iloprost Can Enhance Human Assisted Reproductive Technology Pregnancy Outcomes.

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Drug: Iloprost
* Other: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ART case Exclusion Criteria: age < 40 no pre-implantation genetic diagnosis procedure

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Iloprost<br>This is the study group with 1 uM Iloprost. | Drug: Iloprost<br>* supplement in culture medium during culture in the lab. The concentration is 1 uM.<br>* Other names: Ilomedin;|
| Control<br>This is the control group with vehicle (normal saline) only. | Other: normal saline<br>* Supplement with vehicle only no Iloprost.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The delivery outcome is the secondary outcome measured. | The live birth and the weight and length of baby is examined. | 10 months after embryo transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human ART, Prostacyclin, Iloprost, Pregnancy