Proteomics & Glyco-Proteomic Analysis of Follicular Fluid
NCT ID: NCT01487486
Last Updated: 2011-12-07
Study Results
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Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2011-12-31
2014-01-31
Brief Summary
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Specific Aims
1. To perform a comprehensive analysis of normal human FF using sensitive mass spectrometry in combination with conventional approaches for proteomic evaluation and using HPLC and Western blot for glyco-proteomic analysis.
2. Characterize differential proteomic and glyco-proteomic patterns of the FF in normal women compared to lean and obese women with PCOS.
3. To supplement the differential proteomic and glyco-proteomic analysis with steroid hormone analysis in all FF samples.
Detailed Description
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Human FF bathes the developing oocyte. Previous studies indicate that the FF contains cytokines, steroidal and protein hormones, and growth factors. The presence of proteins with such significant biological properties implies a paracrine and autocrine role for the FF in promoting normal oocyte development. Furthermore, the presence of any antigenic sialic acid Neu5Gc and the presence of antibodies targeting these antigenic glycoconjugates (glycolipid and glycoproteins decorated with sialic acid) may interfere with oocyte development, hormonal expression, fertilization, and possibly implantation. Here we hypothesize that an exhaustive proteomic and glyco-proteomic characterization of human FF is essential for a thorough understanding of its biological significance. We also hypothesize that PCOS may have differential expression of the FF protein and glyco-protein milieu, and that the expression may differ further between lean and obese women with PCOS. PCOS represents a heterogeneous disorder. The severity of hyperandrogensim, metabolic and menstrual disturbance, and obesity is variable with up to 40% not clinically expressing signs of classic hyperandrogenism. On the other hand, these atypical, often lean, PCOS women can have impaired glucose tolerance and diabetes. Reports suggest that these lean PCOS women have altered serum IGFBP-1, a characteristic endocrine feature of patients with obese PCOS, and related to hyperinsulinemia and/or obesity. The lean phenotype of PCOS and its significance is unclear but may represent a cryptic or unexpressed form of PCOS or may be a prelude to individuals who will later manifest clinical signs of obese/overweight PCOS. Changes in expression may be expected because of the different amounts of steroidal hormones and inflammatory markers in the FF derived from women with PCOS.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Normal patients
Women with infertility diagnosis of male factor only or women who are oocyte donors
IVF Antagonist Protocol
1. Ovulation Induction: Achieved with recombinant FSH (Follistim®) with or without HMG (Menopur®) at total doses of 75-450 IU/day subcutaneous (SC) for 9-14 days.
2. Ovulation Suppression: GnRH Antagonist (Ganirelix® - 250microgram 0.5ml) will be initiated following ovulation induction when lead follicle \>14mm diameter on ultrasound and continued through the day of hCG (Novirel® or Ovidrel ®) injection
3. hCG Injection: Once patient has met criteria for oocyte retrieval, she will inject either Novarel® (5,000-10,000 units Intramuscular) or Ovidrel® (250microgram - 500microgram SC) 35 hours prior to oocyte retrieval.
Polycystic Ovary Syndrome, High BMI
Women with Polycystic Ovary Syndrome with a BMI between 30-35
IVF Antagonist Protocol
1. Ovulation Induction: Achieved with recombinant FSH (Follistim®) with or without HMG (Menopur®) at total doses of 75-450 IU/day subcutaneous (SC) for 9-14 days.
2. Ovulation Suppression: GnRH Antagonist (Ganirelix® - 250microgram 0.5ml) will be initiated following ovulation induction when lead follicle \>14mm diameter on ultrasound and continued through the day of hCG (Novirel® or Ovidrel ®) injection
3. hCG Injection: Once patient has met criteria for oocyte retrieval, she will inject either Novarel® (5,000-10,000 units Intramuscular) or Ovidrel® (250microgram - 500microgram SC) 35 hours prior to oocyte retrieval.
Polycystic Ovary Syndrome, Low BMI
Women with Polycustic Ovary Syndrom with a BMI between 20 \& 25
IVF Antagonist Protocol
1. Ovulation Induction: Achieved with recombinant FSH (Follistim®) with or without HMG (Menopur®) at total doses of 75-450 IU/day subcutaneous (SC) for 9-14 days.
2. Ovulation Suppression: GnRH Antagonist (Ganirelix® - 250microgram 0.5ml) will be initiated following ovulation induction when lead follicle \>14mm diameter on ultrasound and continued through the day of hCG (Novirel® or Ovidrel ®) injection
3. hCG Injection: Once patient has met criteria for oocyte retrieval, she will inject either Novarel® (5,000-10,000 units Intramuscular) or Ovidrel® (250microgram - 500microgram SC) 35 hours prior to oocyte retrieval.
Interventions
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IVF Antagonist Protocol
1. Ovulation Induction: Achieved with recombinant FSH (Follistim®) with or without HMG (Menopur®) at total doses of 75-450 IU/day subcutaneous (SC) for 9-14 days.
2. Ovulation Suppression: GnRH Antagonist (Ganirelix® - 250microgram 0.5ml) will be initiated following ovulation induction when lead follicle \>14mm diameter on ultrasound and continued through the day of hCG (Novirel® or Ovidrel ®) injection
3. hCG Injection: Once patient has met criteria for oocyte retrieval, she will inject either Novarel® (5,000-10,000 units Intramuscular) or Ovidrel® (250microgram - 500microgram SC) 35 hours prior to oocyte retrieval.
Eligibility Criteria
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Inclusion Criteria
2. Age \<35 y/o at time of in vitro fertilization (IVF) cycle
3. Normal ovarian function defined Day 3 Follicular Stimulating Hormone (FSH) \<8 pg/ml or Anti-Mullerian Hormone (≥ 1.0 ng/ml)
1. Female patients undergoing COH and TVA donating her oocytes
2. Female patients undergoing COH and TVA for male factor infertility only (i.e. no female causes of infertility)
3. Normal menstrual cycles
1. Diagnosis of PCOS by Rotterdam Criteria
1\. Diagnosis of PCOS by Rotterdam Criteria 2. BMI \> 30 kg/m2
Exclusion Criteria
2. Female partners with infertility associated diagnosis (i.e. tubal factor, cervical factor, endometriosis)
3. Unexplained infertility
18 Years
FEMALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
University of Cincinnati
OTHER
Responsible Party
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Steven Lindheim
Professor
Principal Investigators
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Steven Lindheim, MD, MMM
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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Center for Reproductive Health
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Steven Lindheim, MD, MMM
Role: primary
Julie Sroga, MD
Role: backup
References
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Farquhar CM, Birdsall M, Manning P, Mitchell JM, France JT. The prevalence of polycystic ovaries on ultrasound scanning in a population of randomly selected women. Aust N Z J Obstet Gynaecol. 1994 Feb;34(1):67-72. doi: 10.1111/j.1479-828x.1994.tb01041.x.
Carmina E, Lobo RA. Do hyperandrogenic women with normal menses have polycystic ovary syndrome? Fertil Steril. 1999 Feb;71(2):319-22. doi: 10.1016/s0015-0282(98)00455-5.
Carmina E, Wong L, Chang L, Paulson RJ, Sauer MV, Stanczyk FZ, Lobo RA. Endocrine abnormalities in ovulatory women with polycystic ovaries on ultrasound. Hum Reprod. 1997 May;12(5):905-9. doi: 10.1093/humrep/12.5.905.
Clayton RN, Ogden V, Hodgkinson J, Worswick L, Rodin DA, Dyer S, Meade TW. How common are polycystic ovaries in normal women and what is their significance for the fertility of the population? Clin Endocrinol (Oxf). 1992 Aug;37(2):127-34. doi: 10.1111/j.1365-2265.1992.tb02296.x.
Mendoza C, Ruiz-Requena E, Ortega E, Cremades N, Martinez F, Bernabeu R, Greco E, Tesarik J. Follicular fluid markers of oocyte developmental potential. Hum Reprod. 2002 Apr;17(4):1017-22. doi: 10.1093/humrep/17.4.1017.
Polson DW, Adams J, Wadsworth J, Franks S. Polycystic ovaries--a common finding in normal women. Lancet. 1988 Apr 16;1(8590):870-2. doi: 10.1016/s0140-6736(88)91612-1.
Suikkari AM, Koivisto VA, Rutanen EM, Yki-Jarvinen H, Karonen SL, Seppala M. Insulin regulates the serum levels of low molecular weight insulin-like growth factor-binding protein. J Clin Endocrinol Metab. 1988 Feb;66(2):266-72. doi: 10.1210/jcem-66-2-266.
Conover CA, Lee PD, Kanaley JA, Clarkson JT, Jensen MD. Insulin regulation of insulin-like growth factor binding protein-1 in obese and nonobese humans. J Clin Endocrinol Metab. 1992 Jun;74(6):1355-60. doi: 10.1210/jcem.74.6.1375600.
Other Identifiers
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Proteomics of FF in PCOS
Identifier Type: -
Identifier Source: org_study_id