Clinical trial · Observational
Proteomics & Glyco-Proteomic Analysis of Follicular Fluid
Proteomics & Glyco-Proteomic Analysis of Follicular Fluid Derived From Health Patient/Donors and Polycystic Ovary Syndrome Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To the best of the investigators knowledge, exhaustive characterization of the low and high abundant proteins and glyco-proteins of the Follicular Fluid (FF) has not yet been achieved. Such an analysis may provide critical molecular data on the role of the FF in oocyte maturation and may identify specific changes in the FF proteome of patients with gynecologic problems, such as Polycystic Ovary Syndrome (PCOS). 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Normal Volunteers | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IVF Antagonist Protocol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Normal patients
- description
- Women with infertility diagnosis of male factor only or women who are oocyte donors
- interventionNames
- Drug: IVF Antagonist Protocol
- label
- Polycystic Ovary Syndrome, High BMI
- description
- Women with Polycystic Ovary Syndrome with a BMI between 30-35
- interventionNames
- Drug: IVF Antagonist Protocol
- label
- Polycystic Ovary Syndrome, Low BMI
- description
- Women with Polycustic Ovary Syndrom with a BMI between 20 \& 25
- interventionNames
- Drug: IVF Antagonist Protocol
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: Inclusion Criteria All 1. Female patients undergoing controlled ovarian hyperstimulation (COH), transvaginal oocyte aspiration (TVA), and Saline Infused Sonography (SIS) with UL collection 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) Inclusion Criteria Controls: 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 Inclusion Criteria Lean PCOS: 1. Diagnosis of PCOS by Rotterdam Criteria 2. BMI ≤ 25 kg/m2 Inclusion Criteria Classic PCOS 1\. Diagnosis of PCOS by Rotterdam Criteria 2. BMI \> 30 kg/m2 Exclusion criteria: 1. Age ≥ 35 y/o 2. Female partners with infertility associated diagnosis (i.e. tubal factor, cervical factor, endometriosis) 3. Unexplained infertility
References
Publications (8)
- BACKGROUNDFarquhar 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. PMID 8053879
- BACKGROUNDCarmina 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. PMID 9988405
- BACKGROUNDCarmina 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. PMID 9194637
- BACKGROUNDClayton 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. PMID 1395063
- BACKGROUNDMendoza 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. PMID 11925399
- BACKGROUNDPolson 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. PMID 2895373
- BACKGROUNDSuikkari 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. PMID 2448329