Follicle Stimulating Hormone (FSH) Receptor Polymorphisms in In-Vitro Fertilization Cycles.
The Use of FSH Receptor Polymorphisms To Improve Pregnancy Rates In In-Vitro Fertilization
1 other identifier
observational
75
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2009
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 26, 2009
CompletedFirst Posted
Study publicly available on registry
October 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedDecember 10, 2013
December 1, 2013
3.7 years
October 26, 2009
December 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
3 years
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Endometriosis
- Polycystic ovarian syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Reproductive Associateslead
- Ferring Pharmaceuticalscollaborator
Study Sites (2)
University Reproductive Associates
Hasbrouck Heights, New Jersey, 07604, United States
University Reproductive Associates
Hoboken, New Jersey, 07030, United States
Biospecimen
2 EDTA containing lavender topped tubes will be collected before, during or within 3 months after an IVF cycle. Genomic DNA will be extracted and saved for genotyping.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aimee Seungdamrong, MD
University Reproductive Associates
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
October 26, 2009
First Posted
October 28, 2009
Study Start
July 1, 2009
Primary Completion
March 1, 2013
Study Completion
May 1, 2013
Last Updated
December 10, 2013
Record last verified: 2013-12