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

NCT ID: NCT06863337

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-26
• Study Completion Date: 2027-04-30

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.

Conditions

Infertility Female

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CGM

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 6th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jian Zhou

Principal Investigator, Professor, Chief Physician, Deputy Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian Zhou, Dr.

Role: CONTACT

Phone: +86 021 24056515

Email: zhoujian@sjtu.edu.cn

Facility Contacts

Li Cao, B.S.

Role: primary

Other Identifiers

20250303

Identifier Type: -

Identifier Source: org_study_id