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

NCT06863337 | Recruiting DMC FDA Device

• 1 other identifier: 20250303
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility Female

Outcome Measures

Primary Outcomes (1)

• Mean sensor glucose (MSG)

  Mean of daily continuous 24-h blood glucose

  Through study completion (during assisted reproductive treatment period，about 2 months）

Secondary Outcomes (5)

• time in tight range(3.9~7.8mmol/L, %)

  Through study completion (during assisted reproductive treatment period，about 2 months）

• Time below range (<3.9mmol/L, %)

  Through study completion (during assisted reproductive treatment period，about 2 months）

• Time above range (>7.8mmol/L, %)

  Through study completion (during assisted reproductive treatment period，about 2 months）

• Coefficient of variation (CV)

  Through study completion (during assisted reproductive treatment period，about 2 months）

• Standard deviation (SD)

  Through study completion (during assisted reproductive treatment period，about 2 months）

Other Outcomes (9)

• Number of oocytes retrieved

  Through study completion (during assisted reproductive treatment period，about 2 months）

• Oocyte retrieval rate

  Through study completion (during assisted reproductive treatment period，about 2 months）

• Number of MII oocytes

  Through study completion (during assisted reproductive treatment period，about 2 months）

Study Arms (1)

wearing continuous glucose monitorings

EXPERIMENTAL

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

Interventions

CGM 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.

wearing continuous glucose monitorings

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Central Study Contacts

Jian Zhou, Dr.

CONTACT

+86 021 24056515; zhoujian@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor, Chief Physician, Deputy Director

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: March 26, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)