Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
ID06863337

Glucose Pattern in Infertile Women Receiving Assisted Reproduction Using Continuous Glucose Monitoring

Led by Shanghai 6th People's Hospital · Updated on 2025-12-23

100

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Infertility affects about 20% of couples of reproductive age worldwide, leading to increased use of assisted reproductive technologies (ART). This research aims to continuously observe blood glucose changes during ART treatment in infertile women using continuous glucose monitoring (CGM). The goal is to explore whether glucose variation influences assisted reproduction outcomes and to improve clinical pregnancy and live birth rates through tailored treatment. Participants will wear two FreeStyle Libre Pro Flash CGM devices during key periods of their ovarian stimulation. The first sensor collects baseline glucose data before starting ovulation induction, and the second sensor tracks glucose continuously during the ovulation induction cycle for 14 days. This protocol allows detailed glucose monitoring throughout the ART regimen. During the study, glucose levels will be carefully monitored and recorded, including mean sensor glucose, time within target glucose range, and glucose variability. The study lasts about two months during the assisted reproductive treatment period. Researchers will use this data to understand glucose patterns and their potential impact on ART success, supporting individualized care for patients undergoing infertility treatments.

CONDITIONS

Brief Title

Glucose Pattern in Infertile Women Receiving Assisted Reproduction Using Continuous Glucose Monitoring

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide informed consent and voluntarily agree to participate
  • Be female aged 18 to 40 years
  • Infertile and undergoing first or second IVF/ICSI cycle at the study center
  • Scheduled to receive GnRH antagonist or progesterone-promoting ovulation (PPOS) regimen for ovulation induction
Not Eligible

You will not qualify if you...

  • Recent infections (excluding viral infections like HPV of the reproductive system)
  • Recent glucocorticoid treatment or chemotherapy
  • Medical conditions affecting assisted reproduction outcomes such as repeated implantation failure, recurrent miscarriage, history of unilateral ovary removal, uterine malformations, or parental chromosomal abnormalities
  • Inability to tolerate adhesive sensors or having allergies or serious skin diseases (e.g., psoriasis, bacterial skin infections) around sensor placement area

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - About 2 months

Participants will wear two FreeStyle Libre Pro Flash continuous glucose monitors (CGM) to continuously track blood glucose levels at key time points throughout the ovarian stimulation process during assisted reproductive treatment.

2 sensor placement visits and 2 sensor removal visits

Trial Site Locations

Total: 1 location

1

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China, 200233

Actively Recruiting

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Research Team

J

Jian Zhou, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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