Follicular Fluid Raman Shifts and IVF Outcomes

April 8, 2021 updated by: ShangHai Ji Ai Genetics & IVF Institute

The Correlation Between Follicular Fluid Raman Spectrum and Embryo Development in Infertile Patients With Polycystic Ovary Syndrome

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Recruiting
        • Shanghai JiAi Genetics and IVF Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PCOS follicular fluid
Diagnostic test: Raman spectrum
The wavelength of the follicular fluids were scaned by Raman spectrum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ShangHai Ji Ai Genetics & IVF Institute

Investigators

  • Study Chair: Xiaoxi Sun, Prof., Shanghai JiAi Genetics & IVF Institute
  • Principal Investigator: Jing Fu, Dr., Shanghai JiAi Genetics & IVF Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2019

Primary Completion (Anticipated)

June 19, 2021

Study Completion (Anticipated)

December 19, 2021

Study Registration Dates

First Submitted

April 3, 2021

First Submitted That Met QC Criteria

April 8, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

April 9, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JIAI E2019-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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