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

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.

Study Overview

• Status: Completed
• Conditions: Infertility

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 Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Reproductive Associates
• Collaborators: Ferring Pharmaceuticals
• Investigators: Principal Investigator: Aimee Seungdamrong, MD, University Reproductive Associates

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: October 26, 2009
• First Submitted That Met QC Criteria: October 26, 2009
• First Posted (Estimate): October 28, 2009

Study Record Updates

• Last Update Posted (Estimate): December 10, 2013
• Last Update Submitted That Met QC Criteria: December 9, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Infertility; FSH Receptor Polymorphisms
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 0120090163