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NCT Number: NCT06863337

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location status: Recruiting

Location contact

Li Cao, B.S.

CONTACT

[email protected]

+86 18800257949

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Mean sensor glucose (MSG)

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

    Mean of daily continuous 24-h blood glucose

Secondary outcomes

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

    Time frame: 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

  2. Time below range (<3.9mmol/L, %)

    Time frame: 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.

  3. Time above range (>7.8mmol/L, %)

    Time frame: 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

  4. Coefficient of variation (CV)

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

    Standard deviation divided by mean glucose level measured by CGM

  5. Standard deviation (SD)

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

    Standard deviation of blood glucose measurements during CGM

Other outcomes

  1. Number of oocytes retrieved

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

    The number of oocytes obtained under ultrasound guidance

  2. Oocyte retrieval rate

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

    Oocyte Retrieval Rate = Number of Oocytes Retrieved / Number of Follicles

  3. Number of MII oocytes

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

    The number of metaphase II oocytes that have nuclear maturity at the time of injection

  4. Rate of MII oocytes

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

    the proportion of oocytes that have nuclear maturity at the time of injection

  5. Rate of high-quality embryos

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

    the proportion of Day 2 and Day 3 embryos with high score or grade

  6. Biochemical pregnancy rate

    Time frame: Through study completion (during assisted reproductive treatment period,about 6 months)

    The proportion of pregnancies confirmed by the detection of hCG in serum or urine, but without ultrasound confirmation of a gestational sac or fetal heartbeat.

  7. Clinical pregnancy rate

    Time frame: Through study completion (during assisted reproductive treatment period,about 6 months)

    The proportion of pregnancies confirmed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy

  8. Miscarriage rate

    Time frame: Through study completion, about 1 year

    The proportion of pregnancies that end spontaneously before 28 weeks of gestation after confirmation of clinical pregnancy

  9. Live Birth Rate

    Time frame: Through study completion, 18 months

    The proportion of successful deliveries resulting in a live-born infant.

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Zhou, Dr.

CONTACT

[email protected]

+86 021 24056515

Sponsors and collaborators

Lead sponsor

Shanghai 6th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 7, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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