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

Glucose Pattern in Infertile Women Receiving Assisted Reproduction: a Prospective Study Using Continuous Glucose Monitoring

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility Female
• Intervention / Treatment: Device: CGM

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Zhou, Dr.; Phone Number: +86 021 24056515; Email: zhoujian@sjtu.edu.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200233
      • Recruiting
      • Shanghai Sixth People's Hospital
      • Contact: Li Cao, B.S.; Phone Number: +86 18800257949; Email: caoli1558@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Informed consent and voluntary participation in this study;
2. Age ≥ 18 years and ≤40 years old;
3. Infertile patients who will undergo their first or second cycle of in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) at the study center;
4. The chosen ovulation promotion regimens is the GnRH antagonist regimen/progesterone-promoting ovulation under hyperprogesterone state (PPOS) regimen.

Exclusion Criteria:

1. Recent infections (excluding viral infections of the reproductive system such as HPV);
2. Recent glucocorticoid treatment or chemotherapy;
3. 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;
4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: wearing continuous glucose monitorings; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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）

Secondary Outcome Measures

Outcome Measure	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, %)	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）

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: 20250303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes