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

Not Applicable

Recruiting

• Conditions: Infertility Female

• Registration Number: NCT06863337
• Lead Sponsor: Shanghai 6th People's Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-06
• Study First Posted: 2025-03-07
• Study Start: 2025-03-26
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-12-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mean sensor glucose (MSG)	Through study completion (during assisted reproductive treatment period，about 2 months）	Mean of daily continuous 24-h blood glucose

Secondary Outcome Measures

Name	Time	Method
time in tight range(3.9~7.8mmol/L, %)	Through study completion (during assisted reproductive treatment period，about 2 months）	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, %)	Through study completion (during assisted reproductive treatment period，about 2 months）	Percentage of time below glucose level of 3.9 mmol/L (70 mg/dL) measured by CGM.
Time above range (>7.8mmol/L, %)	Through study completion (during assisted reproductive treatment period，about 2 months）	Percentage of time above glucose level of 7.8 mmol/L (140 mg/dL) measured by CGM
Standard deviation (SD)	Through study completion (during assisted reproductive treatment period，about 2 months）	Standard deviation of blood glucose measurements during CGM
Coefficient of variation (CV)	Through study completion (during assisted reproductive treatment period，about 2 months）	Standard deviation divided by mean glucose level measured by CGM

Trial Locations

Locations (1)

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China