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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Infertility Female

Treatments: Device: CGM

Study type: Interventional

Funder types: Other

Identifiers

NCT06863337

20250303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

wearing continuous glucose monitorings

Experimental group

Description:

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.

Treatment:

Device: CGM