Back to resultsFollicular Fluid Raman Shifts and IVF Outcomes
Primary Purpose
Polycystic Ovary Syndrome, IVF
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Raman spectrum
Sponsored by
About this trial
This is an interventional screening trial for Polycystic Ovary Syndrome
Eligibility 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
Sites / Locations
- Shanghai JiAi Genetics and IVF InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PCOS follicular fluid
Arm Description
Outcomes
Primary Outcome Measures
Difference between polycystic ovary syndrome and normal follicular fluids
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04838535
First Posted
April 3, 2021
Last Updated
April 8, 2021
Sponsor
ShangHai Ji Ai Genetics & IVF Institute
1. Study Identification
Unique Protocol Identification Number
NCT04838535
Brief Title
Follicular Fluid Raman Shifts and IVF Outcomes
Official Title
The Correlation Between Follicular Fluid Raman Spectrum and Embryo Development in Infertile Patients With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
June 19, 2021 (Anticipated)
Study Completion Date
December 19, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ShangHai Ji Ai Genetics & IVF Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, IVF
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PCOS follicular fluid
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Raman spectrum
Intervention Description
The wavelength of the follicular fluids were scaned by Raman spectrum
Primary Outcome Measure Information:
Title
Difference between polycystic ovary syndrome and normal follicular fluids
Description
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.
Time Frame
24 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoxi Sun, Prof.
Organizational Affiliation
Shanghai JiAi Genetics & IVF Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jing Fu, Dr.
Organizational Affiliation
Shanghai JiAi Genetics & IVF Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai JiAi Genetics and IVF Institute
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Fu, Dr.
Phone
63459977
Email
fujing_givf@163.com
12. IPD Sharing Statement
Learn more about this trial
Follicular Fluid Raman Shifts and IVF Outcomes
We'll reach out to this number within 24 hrs