Monitoring glucose levels in infertile women undergoing assisted reproduction
Glucose Pattern in Infertile Women Receiving Assisted Reproduction: a Prospective Study Using Continuous Glucose Monitoring
NA · Shanghai 6th People's Hospital · NCT06863337
This study is testing if keeping track of blood sugar levels in women undergoing fertility treatments like IVF can help improve their chances of getting pregnant and having a healthy baby.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Shanghai 6th People's Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06863337 on ClinicalTrials.gov |
What this trial studies
This study aims to continuously monitor glucose variations in infertile women receiving assisted reproductive technologies (ART) such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). By utilizing continuous glucose monitoring (CGM), the research seeks to explore the relationship between glucose fluctuations and ART outcomes, potentially leading to improved clinical pregnancy and live birth rates. The findings may help tailor ART regimens to minimize glucose variation, enhancing individualized patient care. This approach is novel as glucose monitoring is not typically performed during ART cycles.
Who should consider this trial
Good fit: Ideal candidates are infertile women aged 18 to 40 who are undergoing their first or second IVF/ICSI cycle.
Not a fit: Patients with recent infections, glucocorticoid treatment, or specific clinical conditions affecting ART outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pregnancy and live birth rates for women undergoing assisted reproduction.
How similar studies have performed: While this approach of continuous glucose monitoring during ART is novel, similar studies in other contexts have shown promise in optimizing treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Sixth People's Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Jian Zhou, Dr.
- Email: zhoujian@sjtu.edu.cn
- Phone: +86 021 24056515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infertility Female