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Follicular Fluid Raman Shifts and IVF Outcomes

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ClinicalTrials.gov Identifier: NCT04838535
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
ShangHai Ji Ai Genetics & IVF Institute

Study Description
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Brief Summary:
This study intends to collect about 150 cases of follicular fluid samples from PCOS and non-PCOS infertility patients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycles (in clinical routines).We tend to detect Raman metabolic profile of the follicular fluid of the PCOS and non-PCOS groups, and find the correlation between the metabolic profile of the follicular fluid of PCOS patients and the oocyte quality, IVF outcome and subsequent embryo development are also under investigation. Metabolomics analysis was applied to look for markers of follicular fluid in PCOS patients, and further exploring data and strategies to improve the embryonic development potential and IVF outcome of PCOS patients.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome IVF Diagnostic Test: Raman spectrum Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Correlation Between Follicular Fluid Raman Spectrum and Embryo Development in Infertile Patients With Polycystic Ovary Syndrome
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : June 19, 2021
Estimated Study Completion Date : December 19, 2021

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Arms and Interventions
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Arm Intervention/treatment
PCOS follicular fluid Diagnostic Test: Raman spectrum
The wavelength of the follicular fluids were scaned by Raman spectrum


Outcome Measures
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Primary Outcome Measures :
  1. Difference between polycystic ovary syndrome and normal follicular fluids [ Time Frame: 24 months ]
    Raman spectrum was applied and the Raman spectrum characteristic absorption peak can be revealed. PCA analysis was used to measure the degree of differential shifts.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients fit the Rotterdam criteria for PCOS
  • Patients under IVF cycles

Exclusion Criteria:

  • Patients with male factors infertility
  • Patients with fallopian tube factors infertility
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04838535


Locations
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China, Shanghai
Shanghai JiAi Genetics and IVF Institute Recruiting
Shanghai, Shanghai, China, 200011
Contact: Jing Fu, Dr.    63459977    fujing_givf@163.com   
Sponsors and Collaborators
ShangHai Ji Ai Genetics & IVF Institute
Investigators
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Study Chair: Xiaoxi Sun, Prof. Shanghai JiAi Genetics & IVF Institute
Principal Investigator: Jing Fu, Dr. Shanghai JiAi Genetics & IVF Institute
More Information
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Responsible Party: ShangHai Ji Ai Genetics & IVF Institute
ClinicalTrials.gov Identifier: NCT04838535    
Other Study ID Numbers: JIAI E2019-09
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
 Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases