About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed consent and voluntary participation in this study;
Age ≥ 18 years and ≤40 years old;
Infertile patients who will undergo their first or second cycle of in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) at the study center;
The chosen ovulation promotion regimens is the GnRH antagonist regimen/progesterone-promoting ovulation under hyperprogesterone state (PPOS) regimen.
Disqualifiers
Recent infections (excluding viral infections of the reproductive system such as HPV);
Recent glucocorticoid treatment or chemotherapy;
Clinical conditions affecting the outcome of assisted reproduction, including repeated implantation failure, recurrent spontaneous abortion, history of unilateral oophorectomy, uterine malformations, and parental karyotype abnormalities;
Participants were unable to tolerate tape adhesive around sensor placement area, or with medically documented allergy towards the adhesive (glue) of plasters, or with serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) around sensor placement area.
Trial design
Single group
Treatments tested in this trial
CGM
DeviceEach 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.
Treatment groups
Trial outcomes
Primary outcomes
Mean sensor glucose (MSG)
Mean of daily continuous 24-h blood glucose
Secondary outcomes
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 below range (<3.9mmol/L, %)
Percentage of time below glucose level of 3.9 mmol/L (70 mg/dL) measured by CGM.
Time above range (>7.8mmol/L, %)
Percentage of time above glucose level of 7.8 mmol/L (140 mg/dL) measured by CGM
Coefficient of variation (CV)
Standard deviation divided by mean glucose level measured by CGM
Other outcomes
Number of oocytes retrieved
The number of oocytes obtained under ultrasound guidance
Oocyte retrieval rate
Oocyte Retrieval Rate = Number of Oocytes Retrieved / Number of Follicles
Number of MII oocytes
The number of metaphase II oocytes that have nuclear maturity at the time of injection
Rate of MII oocytes
the proportion of oocytes that have nuclear maturity at the time of injection
Sponsors and contacts
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