Clinical trial NCT06863337: Glucose Pattern in Infertile Women Receiving Assisted Reproduction Using Continuous Glucose Monitoring
Official title: Glucose Pattern in Infertile Women Receiving Assisted Reproduction: a Prospective Study Using Continuous Glucose Monitoring
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility Female
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Mean sensor glucose (MSG)
timeFrame: Through study completion (during assisted reproductive treatment period，about 2 months）
Secondary outcomes:
measure: time in tight range(3.9~7.8mmol/L, %)
timeFrame: Through study completion (during assisted reproductive treatment period，about 2 months）
measure: Time below range (<3.9mmol/L, %)
timeFrame: Through study completion (during assisted reproductive treatment period，about 2 months）
measure: Time above range (>7.8mmol/L, %)
timeFrame: Through study completion (during assisted reproductive treatment period，about 2 months）
measure: Coefficient of variation (CV)
timeFrame: Through study completion (during assisted reproductive treatment period，about 2 months）
measure: Standard deviation (SD)
timeFrame: Through study completion (during assisted reproductive treatment period，about 2 months）
Other outcomes:
measure: Number of oocytes retrieved
timeFrame: Through study completion (during assisted reproductive treatment period，about 2 months）
measure: Oocyte retrieval rate
timeFrame: Through study completion (during assisted reproductive treatment period，about 2 months）
measure: Number of MII oocytes
timeFrame: Through study completion (during assisted reproductive treatment period，about 2 months）
measure: Rate of MII oocytes
timeFrame: Through study completion (during assisted reproductive treatment period，about 2 months）
measure: Rate of high-quality embryos
timeFrame: Through study completion (during assisted reproductive treatment period，about 2 months）
measure: Biochemical pregnancy rate
timeFrame: Through study completion (during assisted reproductive treatment period，about 6 months）
measure: Clinical pregnancy rate
timeFrame: Through study completion (during assisted reproductive treatment period，about 6 months）
measure: Miscarriage rate
timeFrame: Through study completion, about 1 year
measure: Live Birth Rate
timeFrame: Through study completion, 18 months
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
Study officials:
References: