Clinical trial NCT01002885: Follicle Stimulating Hormone (FSH) Receptor Polymorphisms in In-Vitro Fertilization Cycles.
Official title: The Use of FSH Receptor Polymorphisms To Improve Pregnancy Rates In In-Vitro Fertilization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Infertility
FSH Receptor Polymorphisms
Lead sponsor: University Reproductive Associates
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2009-10-28
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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.

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 criteria: 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

Primary outcomes:
measure: The primary outcome measure is to evaluate the frequency of FSH receptor polymorphisms in our population.
timeFrame: 3 years
Secondary outcomes:
measure: 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.
timeFrame: 3 years
Other outcomes:
Locations:
city: Hasbrouck Heights
country: United States
facility: University Reproductive Associates
state: New Jersey
city: Hoboken
country: United States
facility: University Reproductive Associates
state: New Jersey
Study officials:
affiliation: University Reproductive Associates
name: Aimee Seungdamrong, MD
role: PRINCIPAL_INVESTIGATOR
References: