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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorShanghai 6th People's Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: wearing continuous glucose monitoringsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

1

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)
2

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)
3

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)
4

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)

Sponsors and contacts

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