Follicle Stimulating Hormone (FSH) Receptor Polymorphisms in In-Vitro Fertilization Cycles. - Full Text View

Sponsor:	University Reproductive Associates
Collaborator:	Ferring Pharmaceuticals
Information provided by (Responsible Party):	Peter McGovern, MD, University Reproductive Associates
ClinicalTrials.gov Identifier:	NCT01002885

Purpose

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.

Condition
Infertility

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	The Use of FSH Receptor Polymorphisms To Improve Pregnancy Rates In In-Vitro Fertilization

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Infertility

U.S. FDA Resources

Further study details as provided by University Reproductive Associates:

Primary Outcome Measures:

The primary outcome measure is to evaluate the frequency of FSH receptor polymorphisms in our population. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

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.

Estimated Enrollment:	100
Study Start Date:	July 2009
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria patients who have:

Endometriosis
Polycystic ovarian syndrome

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002885

Locations

United States, New Jersey
University Reproductive Associates
Hasbrouck Heights, New Jersey, United States, 07604
University Reproductive Associates
Hoboken, New Jersey, United States, 07030

Sponsors and Collaborators

University Reproductive Associates

Ferring Pharmaceuticals

Investigators

Principal Investigator:

Aimee Seungdamrong, MD

University Reproductive Associates

More Information

No publications provided

Responsible Party:	Peter McGovern, MD, Director, University Reproductive Associates
ClinicalTrials.gov Identifier:	NCT01002885 History of Changes
Other Study ID Numbers:	0120090163
Study First Received:	October 26, 2009
Last Updated:	April 11, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University Reproductive Associates:

Infertility
FSH Receptor Polymorphisms

Additional relevant MeSH terms:

Infertility
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012