InfertilityNCT00460642
GnRH Antagonist to Prepare Recipients for Embryo Transfer
A study testing GnRH Antagonist (Cetrotide) in people with Infertility, run by Institute for Human Reproduction (IHR) at 2 sites in United States.
Trial summary
26% of all ART cycles performed in the USA in 2003 (CDC data) are frozen embryo transfers (FET) and transfer of embryos resulting from egg donation (ED) to recipients. The typical protocol used to prepare a recipient for ET involves GnRH agonist (Lupron, Tap Pharmaceuticals) to down regulate the patient. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- GnRH Antagonist (Cetrotide)
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2007to Dec 2009
- Phase
- Interventional
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- History of infertility before cryopreserving the embryos or inability to conceive from her own oocytes (based on age and/or a serum FSH > 15 IU/L).
- Any patient desiring to become pregnant as a result of transferring frozen-thawed embryos generated using her own or donor oocytes.
- Subject is in good health as determined by the Investigator on the basis of medical history, physical examination and laboratory screening tests.
- A negative pregnancy test prior to starting treatment with estrogens.
Who cannot join
- Women with a history of liver and/or kidney disease
- Hypertension: systolic pressure over 180 mm Hg or diastolic pressure over 105 at any study visit, measured twice 6 hours apart despite active treatment for hypertension.
- Liver function tests of two times than the upper limit of normal
- Women with active sever endometriosis.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institute for Human Reproduction (IHR)
Chicago, Illinois, 60657
Institute for Human Reproduction (IHR)
Oakbrook Terrace, Illinois, 60181
About this study
Official title: Use of GnRH Antagonist (Cetrotide) Protocol, Instead of Agonist, to Prepare Recipients for Embryo Transfer
26% of all ART cycles performed in the USA in 2003 (CDC data) are frozen embryo transfers (FET) and transfer of embryos resulting from egg donation (ED) to recipients. The typical protocol used to prepare a recipient for ET involves GnRH agonist (Lupron, Tap Pharmaceuticals) to down regulate the patient. A GnRH antagonist, such as Cetrotide (EMD Serono), is comparable to GnRH agonist and FDA approved to prevent spontaneous ovulation with ART treatment, and its usage decreases significantly the number of injections that the patient receives with treatment. The working hypothesis for this study is that the GnRH antagonist (Cetrotide) can be used instead of an agonist to achieve effective down regulation in FET and ED cycles. Presumably, patients will prefer Cetrotide over Lupron because of the markedly fewer injections required.
- Conditions
- Infertility
- Being tested
- GnRH Antagonist (Cetrotide)
- Keywords
- Frozen embryo transfers (FET)., Egg donation (ED)., IVF., ART., Implantation., GnRH antagonist., Cetrotide., Endometrial response., Infertility treatments:, Transfer of embryos from egg donation (ED) to recipients.
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH Antagonist (Cetrotide)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate
Secondary outcomes (1)
Delivery Rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2007 (estimated)
- Study startJan 2007
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Human Reproduction (IHR)
- Sponsor type
- University, hospital or other
- Investigators
- Ilan Tur-Kaspa, MD, Principal investigator, President and Medical Director, Institute for Human Reproduction (IHR) and Director, Clinical IVF-PGD Program, Reproductive Genetics Institute (RGI).
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460642
- Sponsor's protocol ID
- IND 74,817
- Status last verified
- May 2010
- First submitted
- 12 Apr 2007
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of GnRH Antagonist (Cetrotide) Protocol, Instead of Agonist, to Prepare Recipients for Embryo Transfer
- ClinicalTrials.gov ID
- NCT00460642
- Acronym / sponsor ID
- IND 74,817
- Conditions
- Infertility
- Keywords
- Frozen embryo transfers (FET)., Egg donation (ED)., IVF., ART., Implantation., GnRH antagonist., Cetrotide., Endometrial response.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Institute for Human Reproduction (IHR)University, hospital or other
- Study start
- Jan 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Apr 2007 (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.
26% of all ART cycles performed in the USA in 2003 (CDC data) are frozen embryo transfers (FET) and transfer of embryos resulting from egg donation (ED) to recipients. The typical protocol used to prepare a recipient for ET involves GnRH agonist (Lupron, Tap Pharmaceuticals) to down regulate the patient. A GnRH antagonist, such as Cetrotide (EMD Serono), is comparable to GnRH agonist and FDA approved to prevent spontaneous ovulation with ART treatment, and its usage decreases significantly the number of injections that the patient receives with treatment. The working hypothesis for this study is that the GnRH antagonist (Cetrotide) can be used instead of an agonist to achieve effective down regulation in FET and ED cycles. Presumably, patients will prefer Cetrotide over Lupron because of the markedly fewer injections required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- History of infertility before cryopreserving the embryos or inability to conceive from her own oocytes (based on age and/or a serum FSH > 15 IU/L).
- Any patient desiring to become pregnant as a result of transferring frozen-thawed embryos generated using her own or donor oocytes.
- Subject is in good health as determined by the Investigator on the basis of medical history, physical examination and laboratory screening tests.
- A negative pregnancy test prior to starting treatment with estrogens.
Key exclusion criteria (4 listed)
- Women with a history of liver and/or kidney disease
- Hypertension: systolic pressure over 180 mm Hg or diastolic pressure over 105 at any study visit, measured twice 6 hours apart despite active treatment for hypertension.
- Liver function tests of two times than the upper limit of normal
- Women with active sever endometriosis.
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 |
|---|---|---|
| GnRH Antagonist (Cetrotide) | Drug | – |
Primary outcome
Clinical Pregnancy Rate
1 secondary outcome
Delivery Rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2010.
- Related InfoLink provided by the sponsor.
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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.
Ilan Tur-Kaspa, MD principal investigator
President and Medical Director, Institute for Human Reproduction (IHR) and Director, Clinical IVF-PGD Program, Reproductive Genetics Institute (RGI).
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GnRH Antagonist (Cetrotide) in people with Infertility, run by Institute for Human Reproduction (IHR) at 2 sites 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 26 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy Rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2010.