InfertilityNCT01002885
Follicle Stimulating Hormone (FSH) Receptor Polymorphisms in In-Vitro Fertilization Cycles.
An observational study of Infertility, run by University Reproductive Associates at 2 sites in United States.
Trial summary
This study is being done to identify if certain sequences (patterns) of key genes (called polymorphisms) may predict a response to fertility medications. The investigators will also determine if the individual response to fertility medications affects pregnancy rates in in-vitro fertilization. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Infertility
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2009to May 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients undergoing in-vitro fertilization will be recruited. Inclusion criteria will limit the patient population to those patients most likely to have normal ovarian function since age or disease related ovarian dysfunction will confound interpretation of our results.
Who may be able to join
- 100 women less than 35 years old at time of signing the Informed Consent Form.
- Day 3 FSH level less than or equal to 10 mIU/ml with an estradiol < 70 pg/ml
- Day 3 antral follicle count of greater than 10 follicles total.
- Couples who have male factor infertility, tubal factor infertility, and unexplained infertility.
Who cannot join
- Endometriosis
- Polycystic ovarian syndrome
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Reproductive Associates
Hasbrouck Heights, New Jersey, 07604
University Reproductive Associates
Hoboken, New Jersey, 07030
About this study
Official title: The Use of FSH Receptor Polymorphisms To Improve Pregnancy Rates In In-Vitro Fertilization
This study is being done to identify if certain sequences (patterns) of key genes (called polymorphisms) may predict a response to fertility medications. The investigators will also determine if the individual response to fertility medications affects pregnancy rates in in-vitro fertilization.
Read the detailed description
All IVF patients who meet inclusion criteria and not exclusion criteria will be asked to participate in this study. Upon consent, a blood sample will be obtained in 2 EDTA containing lavender topped tubes before, during or within 3 months after their IVF cycle. Genomic DNA will be extracted and saved for genotyping.
The Investigators will collect data on each individual's age, ethnic background, and estradiol levels on the day of hCG administration, total gonadotropin amount, clinical pregnancy rates, basal FSH levels, and occurrence of OHSS. The Investigators will then analyze all samples from all patients for their FSH receptor genotypes.
Patients will be compensated $75 via a check within 6-8 weeks of their blood drawn.
- Conditions
- Infertility
- Keywords
- Infertility, FSH Receptor Polymorphisms
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is to evaluate the frequency of FSH receptor polymorphisms in our population.
The investigators are looking to quantify how often certain FSH receptor Polymorphisms occur in the population and cetain racial groups. We will be looking at patient's race along with the laboratory results.
Measured: 3 years
Secondary outcomes (1)
The secondary outcome is to further clarify the variation in response to FSH due to FSH receptor polymorphisms using the protocols largely used in the United States, including our center.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2013
- Study completionMay 2013
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Reproductive Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Principal investigator, Peter McGovern, MD, University Reproductive Associates
- Investigators
- Aimee Seungdamrong, MD, Principal investigator, University Reproductive Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002885
- Sponsor's protocol ID
- 0120090163
- Status last verified
- Dec 2013
- First submitted
- 26 Oct 2009
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of FSH Receptor Polymorphisms To Improve Pregnancy Rates In In-Vitro Fertilization
- ClinicalTrials.gov ID
- NCT01002885
- Acronym / sponsor ID
- 0120090163
- Conditions
- Infertility
- Keywords
- Infertility, FSH Receptor Polymorphisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Reproductive AssociatesUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Jul 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 28 Oct 2009 (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.
This study is being done to identify if certain sequences (patterns) of key genes (called polymorphisms) may predict a response to fertility medications. The investigators will also determine if the individual response to fertility medications affects pregnancy rates in in-vitro fertilization.
Detailed description
All IVF patients who meet inclusion criteria and not exclusion criteria will be asked to participate in this study. Upon consent, a blood sample will be obtained in 2 EDTA containing lavender topped tubes before, during or within 3 months after their IVF cycle. Genomic DNA will be extracted and saved for genotyping.
The Investigators will collect data on each individual's age, ethnic background, and estradiol levels on the day of hCG administration, total gonadotropin amount, clinical pregnancy rates, basal FSH levels, and occurrence of OHSS. The Investigators will then analyze all samples from all patients for their FSH receptor genotypes.
Patients will be compensated $75 via a check within 6-8 weeks of their blood drawn.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing in-vitro fertilization will be recruited. Inclusion criteria will limit the patient population to those patients most likely to have normal ovarian function since age or disease related ovarian dysfunction will confound interpretation of our results.
Key inclusion criteria (4 listed)
- 100 women less than 35 years old at time of signing the Informed Consent Form.
- Day 3 FSH level less than or equal to 10 mIU/ml with an estradiol < 70 pg/ml
- Day 3 antral follicle count of greater than 10 follicles total.
- Couples who have male factor infertility, tubal factor infertility, and unexplained infertility.
Key exclusion criteria (2 listed)
- Endometriosis
- Polycystic ovarian syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome measure is to evaluate the frequency of FSH receptor polymorphisms in our population.
Time frame: 3 years
The investigators are looking to quantify how often certain FSH receptor Polymorphisms occur in the population and cetain racial groups. We will be looking at patient's race along with the laboratory results.
1 secondary outcome
The secondary outcome is to further clarify the variation in response to FSH due to FSH receptor polymorphisms using the protocols largely used in the United States, including our center.
Time frame: 3 years
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 10 Dec 2013.
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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.
Aimee Seungdamrong, MD principal investigator
University Reproductive Associates
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by University Reproductive Associates 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 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: finished, as of the sponsor's last update on 10 Dec 2013. 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?
The primary outcome measure is to evaluate the frequency of FSH receptor polymorphisms in our population. (time frame: 3 years). 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 10 Dec 2013.