Investigating kisspeptin levels during pregnancy in women with PCOS
A Prospective Cohort Study on the Dynamic Monitoring of Serum Kisspeptin Levels Throughout Pregnancy and Exploring Its Predictive Value for Gestational Diabetes Mellitus in PCOS Patients
This study is trying to see how kisspeptin levels change during pregnancy in women with PCOS and if those changes can help predict gestational diabetes and other pregnancy issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06545994 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to monitor serum kisspeptin levels in women diagnosed with polycystic ovary syndrome (PCOS) throughout their pregnancy. It will analyze how these levels correlate with insulin, glucose, and testosterone at different trimesters. The study seeks to determine the predictive value of kisspeptin for gestational diabetes mellitus (GDM) and other pregnancy complications in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 40 who have been diagnosed with PCOS and are registering for prenatal check-ups during early pregnancy.
Not a fit: Patients with other diseases causing ovulation disorders or hyperandrogenism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into predicting and managing gestational diabetes and other complications in pregnant women with PCOS.
How similar studies have performed: While the specific approach of monitoring kisspeptin levels in this context may be novel, related studies have explored hormonal predictors of pregnancy complications in PCOS with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 40 years old * Women diagnosed as PCOS who register for prenatal check ups in the obstetrics outpatient department of hospitals during early pregnancy.(The diagnostic criteria for PCOS are based on the 2003 Rotterdam diagnostic criteria (any two out of the three key characteristics of PCOS: oligo-amenorrhea, hyperandrogenism, and polycystic-appearing ovarian morphology on ultrasonography) . Exclusion Criteria: * All other diseases with ovulation disorders or hyperandrogenism
Where this trial is running
Shanghai, Shanghai Municipality
- OB & GYN Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Hexia Xia, M.D. — The Obstetrics & Gynecology Hospital of Fudan University
- Study coordinator: Wei Zhang, phD
- Email: zhangwei623@hotmail.com
- Phone: +8613611691036
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.