NCT06863337

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

Glucose Pattern in Infertile Women Receiving Assisted Reproduction: a Prospective Study Using Continuous Glucose Monitoring

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shanghai 6th People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

No studies have been seen on glucose variation during medication for assisted reproduction. The aim of this study is to continuously observe glucose variation during assisted reproduction treatment using continuous glucose monitoring (CGM), and to further explore whether glucose variation will affect the outcomes related to assisted reproduction.

Detailed description

Infertility is a growing global health concern and affects approximately 20% of couples of reproductive age. As a result, the use of assisted reproductive technologies (ART) is becoming more prevalent. This study could serve as a basis for the interpretation of glucose levels with respect to these people undergoing ART regimen. Moreover, the success rate of ART still needs to be further improved. Key challenges include optimizing the hormonal components of ART regimens and determining the ideal treatment duration. This study might provide insights into the potential benefits of monitoring glucose levels at specific points during ART cycles (which is not usually performed in routine practice) and help clinicians tailor ART regimen to minimize glucose variation, ultimately improving clinical pregnancy and live birth rates. Additionally, the findings might support integrating CGM into the clinical practice of ART, enhancing individualized patient care.

Conditions

• Infertility Female

Interventions

Type	Name	Description
DEVICE	CGM	Each patient will participate in the group only once and wear two FreeStyle Libre Pro Flash CGM (Abbott Diabetes Care, Alameda, CA, USA), which record glucose readings for up to 14 days. Following the initial consultation and before initiating the ovulation induction protocol, the first CGM sensor will be placed to collect baseline data. Upon entering the ovulation induction cycle, patients will return to the hospital on the 2nd or 3rd day of menstruation, at which point the first CGM sensor will be removed, and the second sensor will be applied. This second sensor will be removed after 14 days. In summary, this protocol ensures continuous tracking of blood glucose levels at key time points throughout the ovarian stimulation.

Timeline

• Start date: 2025-03-26
• Primary completion: 2026-06-30
• Completion: 2027-04-30
• First posted: 2025-03-07
• Last updated: 2025-12-23

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study