Follicular Fluid Raman Shifts and IVF Outcomes

NCT04838535 | Unknown

• 1 other identifier: JIAI E2019-09
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; IVF

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Study Arms (1)

PCOS follicular fluid

OTHER

Diagnostic Test: Raman spectrum

Interventions

Raman spectrum DIAGNOSTIC_TEST

The wavelength of the follicular fluids were scaned by Raman spectrum

PCOS follicular fluid

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with male factors infertility
• Patients with fallopian tube factors infertility

Sponsors & Collaborators

• ShangHai Ji Ai Genetics & IVF Institute: lead

Study Sites (1)

Shanghai JiAi Genetics and IVF Institute

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Xiaoxi Sun, Prof.

  Shanghai JiAi Genetics & IVF Institute

  STUDY CHAIR

• Jing Fu, Dr.

  Shanghai JiAi Genetics & IVF Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2021
• First Posted: April 9, 2021
• Study Start: June 19, 2019
• Primary Completion: June 19, 2021
• Study Completion: December 19, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

CN (1)