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

NCT ID: NCT01549171

Last Updated: 2012-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Pregnancy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Iloprost

This is the study group with 1 uM Iloprost.

Iloprost

Intervention Type DRUG

supplement in culture medium during culture in the lab. The concentration is 1 uM.

Control

This is the control group with vehicle (normal saline) only.

normal saline

Intervention Type OTHER

Supplement with vehicle only no Iloprost.

Interventions

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Iloprost

supplement in culture medium during culture in the lab. The concentration is 1 uM.

Intervention Type DRUG

normal saline

Supplement with vehicle only no Iloprost.

Intervention Type OTHER

Other Intervention Names

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Ilomedin

Eligibility Criteria

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Inclusion Criteria

* ART case

Exclusion Criteria

* age \< 40
* no pre-implantation genetic diagnosis procedure
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Origio A/S

INDUSTRY

Sponsor Role collaborator

Fertility Specialists of Houston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George M Grunert, M.D.

Role: PRINCIPAL_INVESTIGATOR

Obstetrical & Gynecological Associates

Locations

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Fertility Specialists of Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Wan-Song A Wun, Ph.D.

Role: primary

713-512-7680

George M Grunert, M.D.

Role: backup

713-512-7760

References

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Battenfeld R, Schuh W, Schobel C. Studies on reproductive toxicity of iloprost in rats, rabbits and monkeys. Toxicol Lett. 1995 Aug;78(3):223-34. doi: 10.1016/0378-4274(95)03323-d.

Reference Type BACKGROUND
PMID: 7542807 (View on PubMed)

Grunert GM, Dunn RC, Valdes CT, Schenk LM, Mangal RK, Wun WSA: Prostacyclin agonist (Iloprost) enhances human embryo development. Fertility and Sterility 84:S237, 2005

Reference Type BACKGROUND

Huang JC, Arbab F, Tumbusch KJ, Goldsby JS, Matijevic-Aleksic N, Wu KK. Human fallopian tubes express prostacyclin (PGI) synthase and cyclooxygenases and synthesize abundant PGI. J Clin Endocrinol Metab. 2002 Sep;87(9):4361-8. doi: 10.1210/jc.2002-020199.

Reference Type BACKGROUND
PMID: 12213900 (View on PubMed)

Huang JC, Wun WS, Goldsby JS, Matijevic-Aleksic N, Wu KK. Cyclooxygenase-2-derived endogenous prostacyclin enhances mouse embryo hatching. Hum Reprod. 2004 Dec;19(12):2900-6. doi: 10.1093/humrep/deh524. Epub 2004 Oct 15.

Reference Type BACKGROUND
PMID: 15489241 (View on PubMed)

Huang JC, Goldsby JS, Wun WS. Prostacyclin enhances the implantation and live birth potentials of mouse embryos. Hum Reprod. 2004 Aug;19(8):1856-60. doi: 10.1093/humrep/deh352. Epub 2004 Jun 17.

Reference Type BACKGROUND
PMID: 15205402 (View on PubMed)

Other Identifiers

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OGAFSH-01

Identifier Type: -

Identifier Source: org_study_id

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