An interventional study of CGM in Infertility Female, sponsored by Shanghai 6th People's Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Shanghai 6th People's Hospital · Not applicable, Interventional, and Other
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.
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.
540 studies on the registry are indexed under Infertility, Female; 138 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 371 interventional studies indexed under Infertility, Female.
Browse Infertility, Female studies →Shanghai 6th People's Hospital is the lead sponsor of 69 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will wear two FreeStyle Libre Pro Flash CGM (Abbott Diabetes Care, Alameda, CA, USA) to ensure continuous tracking of blood glucose levels at key time points throughout the ovarian stimulation.
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.
Mean sensor glucose (MSG)
Mean of daily continuous 24-h blood glucose
Time frame: Through study completion (during assisted reproductive treatment period，about 2 months）
time in tight range(3.9~7.8mmol/L, %)
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）
Time below range (<3.9mmol/L, %)
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）
Time above range (>7.8mmol/L, %)
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）
Coefficient of variation (CV)
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 (SD)
Standard deviation of blood glucose measurements during CGM
Time frame: Through study completion (during assisted reproductive treatment period，about 2 months）
Number of oocytes retrieved
The number of oocytes obtained under ultrasound guidance
Time frame: Through study completion (during assisted reproductive treatment period，about 2 months）
Oocyte retrieval rate
Oocyte Retrieval Rate = Number of Oocytes Retrieved / Number of Follicles
Time frame: Through study completion (during assisted reproductive treatment period，about 2 months）
Number of MII oocytes
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）
Rate of MII oocytes
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）
Rate of high-quality embryos
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 2 months）
Biochemical pregnancy rate
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）
Clinical pregnancy rate
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 (during assisted reproductive treatment period，about 6 months）
Miscarriage rate
The proportion of pregnancies that end spontaneously before 28 weeks of gestation after confirmation of clinical pregnancy
Time frame: Through study completion, about 1 year
Live Birth Rate
The proportion of successful deliveries resulting in a live-born infant.
Time frame: Through study completion, 18 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai 6th People's Hospital