Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233, China
Location status: Recruiting
NCT Number: NCT06863337
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.
Interested in participating?
Request Info18 year–40 year
Female
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200233, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Through study completion (during assisted reproductive treatment period,about 2 months)
Mean of daily continuous 24-h blood glucose
Time frame: Through study completion (during assisted reproductive treatment period,about 2 months)
Percentage of time within glucose level of 3.9-7.8 mmol/L (70-140 mg/dL) measured by CGM
Time frame: Through study completion (during assisted reproductive treatment period,about 2 months)
Percentage of time below glucose level of 3.9 mmol/L (70 mg/dL) measured by CGM.
Time frame: Through study completion (during assisted reproductive treatment period,about 2 months)
Percentage of time above glucose level of 7.8 mmol/L (140 mg/dL) measured by CGM
Time frame: Through study completion (during assisted reproductive treatment period,about 2 months)
Standard deviation divided by mean glucose level measured by CGM
Time frame: Through study completion (during assisted reproductive treatment period,about 2 months)
Standard deviation of blood glucose measurements during CGM
Time frame: Through study completion (during assisted reproductive treatment period,about 2 months)
The number of oocytes obtained under ultrasound guidance
Time frame: Through study completion (during assisted reproductive treatment period,about 2 months)
Oocyte Retrieval Rate = Number of Oocytes Retrieved / Number of Follicles
Time frame: Through study completion (during assisted reproductive treatment period,about 2 months)
The number of metaphase II oocytes that have nuclear maturity at the time of injection
Time frame: Through study completion (during assisted reproductive treatment period,about 2 months)
the proportion of oocytes that have nuclear maturity at the time of injection
Time frame: Through study completion (during assisted reproductive treatment period,about 2 months)
the proportion of Day 2 and Day 3 embryos with high score or grade
Time frame: Through study completion (during assisted reproductive treatment period,about 6 months)
The proportion of pregnancies confirmed by the detection of hCG in serum or urine, but without ultrasound confirmation of a gestational sac or fetal heartbeat.
Time frame: Through study completion (during assisted reproductive treatment period,about 6 months)
The proportion of pregnancies confirmed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy
Time frame: Through study completion, about 1 year
The proportion of pregnancies that end spontaneously before 28 weeks of gestation after confirmation of clinical pregnancy
Time frame: Through study completion, 18 months
The proportion of successful deliveries resulting in a live-born infant.
Contact information is provided by the study sponsor or research team.
Shanghai 6th People's Hospital
Other
Glucose Pattern in Infertile Women Receiving Assisted Reproduction: a Prospective Study Using Continuous Glucose Monitoring
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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