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

NCT ID: NCT01002885

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Infertility

Keywords

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Infertility FSH Receptor Polymorphisms

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

1. Endometriosis
2. Polycystic ovarian syndrome
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

University Reproductive Associates

OTHER

Sponsor Role lead

Responsible Party

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Peter McGovern, MD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aimee Seungdamrong, MD

Role: PRINCIPAL_INVESTIGATOR

University Reproductive Associates

Locations

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University Reproductive Associates

Hasbrouck Heights, New Jersey, United States

Site Status

University Reproductive Associates

Hoboken, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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0120090163

Identifier Type: -

Identifier Source: org_study_id