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Recruiting NCT06863337

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

No phase Interventional Infertility Female

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CGM.
Who it may be relevant to
Registry conditions: Infertility Female. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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 wi

Primary outcome measures

  • Mean sensor glucose (MSG) [Time frame: Through study completion (during assisted reproductive treatment period，about 2 months）]
Secondary outcome measures (5)
  • time in tight range(3.9~7.8mmol/L, %) [Time frame: Through study completion (during assisted reproductive treatment period，about 2 months）]
  • Time below range (<3.9mmol/L, %) [Time frame: Through study completion (during assisted reproductive treatment period，about 2 months）]
  • Time above range (>7.8mmol/L, %) [Time frame: Through study completion (during assisted reproductive treatment period，about 2 months）]
  • Coefficient of variation (CV) [Time frame: Through study completion (during assisted reproductive treatment period，about 2 months）]
  • Standard deviation (SD) [Time frame: Through study completion (during assisted reproductive treatment period，about 2 months）]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

China · 1 center
  • Shanghai Sixth People's Hospital — Shanghai

Identifiers

NCT: NCT06863337 · 20250303

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗