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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| wearing continuous glucose monitorings | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGM | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean sensor glucose (MSG) | Mean of daily continuous 24-h blood glucose | Through study completion (during assisted reproductive treatment period，about 2 months） |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion (during assisted reproductive treatment period，about 2 months） |
| Time below range (<3.9mmol/L, %) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of oocytes retrieved | The number of oocytes obtained under ultrasound guidance | Through study completion (during assisted reproductive treatment period，about 2 months） |
| Oocyte retrieval rate | Oocyte Retrieval Rate = Number of Oocytes Retrieved / Number of Follicles |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Zhou, Dr. | Contact | +86 021 24056515 | zhoujian@sjtu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Sixth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200233 | China |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Percentage of time below glucose level of 3.9 mmol/L (70 mg/dL) measured by CGM.
| 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 | 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 | Through study completion (during assisted reproductive treatment period，about 2 months） |
| Standard deviation (SD) | Standard deviation of blood glucose measurements during CGM | Through study completion (during assisted reproductive treatment period，about 2 months） |
| 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 | 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 | 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 | 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. | 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 | 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 | Through study completion, about 1 year |
| Live Birth Rate | The proportion of successful deliveries resulting in a live-born infant. | Through study completion, 18 months |
| D000091662 | Genital Diseases |
| D007246 | Infertility |