PregnancyNCT01549171
Enhanced Assisted Reproductive Technology Pregnancy Rate by Prostacyclin Analog (Iloprost)
An observational study of Pregnancy, run by Fertility Specialists of Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Iloprost and normal saline
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: ART cases with age < 40 and without pre-implantation genetic diagnosis
Who may be able to join
- ART case
Who cannot join
- age < 40
- no pre-implantation genetic diagnosis procedure
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Fertility Specialists of Houston
Houston, Texas, 77054
Wan-Song A Wun, Ph.D., 713-512-7680, awun@obgynassociates.com
George M Grunert, M.D., 713-512-7760, ggrunert@fshivf.com
About this study
Official title: Pilot Study to Examine Iloprost Can Enhance Human Assisted Reproductive Technology Pregnancy Outcomes.
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Iloprost, normal saline
- Keywords
- Human ART, Prostacyclin, Iloprost, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IloprostDrug
Also called Ilomedin
supplement in culture medium during culture in the lab. The concentration is 1 uM.
normal salineOther
Supplement with vehicle only no Iloprost.
| Study group | Role | What they receive |
|---|---|---|
| Iloprost | This is the study group with 1 uM Iloprost. Receives: Drug: Iloprost | |
| Control | This is the control group with vehicle (normal saline) only. Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of embryo sac in uterus under ultrasound
The competency of embryo is determined by its ability to implant into endometirum.
Measured: 5 weeks after embryo transfer
Secondary outcomes (1)
The delivery outcome is the secondary outcome measured.
The live birth and the weight and length of baby is examined.
Measured: 10 months after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startJan 2010
- Primary completionNov 2011
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fertility Specialists of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Origio A/S
- Responsible party
- Sponsor
- Investigators
- George M Grunert, M.D., Principal investigator, Obstetrical & Gynecological Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549171
- Sponsor's protocol ID
- OGAFSH-01
- Status last verified
- Mar 2012
- First submitted
- 6 Mar 2012
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 7542807Grunert GM, Dunn RC, Valdes CT, Schenk LM, Mangal RK, Wun WSA: Prostacyclin agonist (Iloprost) enhances human embryo development. Fertility and Sterility 84:S237, 2005
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.
PubMed 12213900Huang 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.
PubMed 15489241Huang 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.
PubMed 15205402
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Examine Iloprost Can Enhance Human Assisted Reproductive Technology Pregnancy Outcomes.
- ClinicalTrials.gov ID
- NCT01549171
- Acronym / sponsor ID
- OGAFSH-01
- Conditions
- Pregnancy
- Keywords
- Human ART, Prostacyclin, Iloprost, Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fertility Specialists of HoustonUniversity, hospital or other
- Collaborators
- Origio A/S
- Study start
- Jan 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iloprost | – | Drug: IloprostThis is the study group with 1 uM Iloprost. |
| Control | – | Other: normal salineThis is the control group with vehicle (normal saline) only. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- ART cases with age < 40 and without pre-implantation genetic diagnosis
Key inclusion criteria (1 listed)
- ART case
Key exclusion criteria (2 listed)
- age < 40
- no pre-implantation genetic diagnosis procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IloprostAlso: Ilomedinsupplement in culture medium during culture in the lab. The concentration is 1 uM. | Drug | Iloprost |
| normal salineSupplement with vehicle only no Iloprost. | Other | Control |
Primary outcome
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.
1 secondary outcome
The delivery outcome is the secondary outcome measured.
Time frame: 10 months after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
- Background: PubMed 7542807Battenfeld 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.
- BackgroundGrunert GM, Dunn RC, Valdes CT, Schenk LM, Mangal RK, Wun WSA: Prostacyclin agonist (Iloprost) enhances human embryo development. Fertility and Sterility 84:S237, 2005
- Background: PubMed 12213900Huang 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.
- Background: PubMed 15489241Huang 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.
- Background: PubMed 15205402Huang 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.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George M Grunert, M.D. principal investigator
Obstetrical & Gynecological Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Fertility Specialists of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of embryo sac in uterus under ultrasound (time frame: 5 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01549171, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2012.