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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Fertility Specialists of Houston.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Origio A/S
Information provided by (Responsible Party):
Fertility Specialists of Houston
ClinicalTrials.gov Identifier:
NCT01549171
First received: March 6, 2012
Last updated: March 8, 2012
Last verified: March 2012
  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.

Resource links provided by NLM:


Further study details as provided by Fertility Specialists of Houston:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Study Population

ART cases with age < 40 and without pre-implantation genetic diagnosis

Criteria

Inclusion Criteria:

  • ART case

Exclusion Criteria:

  • age < 40
  • no pre-implantation genetic diagnosis procedure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549171

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.         
Sponsors and Collaborators
Fertility Specialists of Houston
Origio A/S
Investigators
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 July 22, 2014