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Completed

NCT Number: NCT01002885

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

University Reproductive Associates, Hasbrouck Heights, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 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.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University Reproductive Associates

Other

Collaborators

  • Ferring Pharmaceuticals

Registry information

Official study title

The Use of FSH Receptor Polymorphisms To Improve Pregnancy Rates In In-Vitro Fertilization

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Oct 28, 2009
Registry last updated
Dec 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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