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

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ClinicalTrials.gov Identifier: NCT01002885
Recruitment Status : Completed
First Posted : October 28, 2009
Last Update Posted : December 10, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease

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

Study Type : Observational
Actual Enrollment : 75 participants
Time Perspective: Prospective
Official Title: The Use of FSH Receptor Polymorphisms To Improve Pregnancy Rates In In-Vitro Fertilization
Study Start Date : July 2009
Primary Completion Date : March 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  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. [ Time Frame: 3 years ]

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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.

Inclusion Criteria:

  1. 100 women less than 35 years old at time of signing the Informed Consent Form.
  2. Day 3 FSH level less than or equal to 10 mIU/ml with an estradiol < 70 pg/ml
  3. Day 3 antral follicle count of greater than 10 follicles total.
  4. Couples who have male factor infertility, tubal factor infertility, and unexplained infertility.

Exclusion Criteria patients who have:

  1. Endometriosis
  2. Polycystic ovarian syndrome
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002885

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
Principal Investigator: Aimee Seungdamrong, MD University Reproductive Associates
More Information

Responsible Party: Peter McGovern, MD, Director, University Reproductive Associates
ClinicalTrials.gov Identifier: NCT01002885     History of Changes
Other Study ID Numbers: 0120090163
First Posted: October 28, 2009    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013

Keywords provided by Peter McGovern, MD, University Reproductive Associates:
FSH Receptor Polymorphisms

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs