Prospective Early Pregnancy Cohort and Preimplantation Factor: Factors Related to Successful Implantation, Risk of Miscarriage and Recurrent Pregnancy Loss in the First Trimester
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 主要终点
- Prediction model for the risk of spontaneous abortion
研究概览
简要总结
Miscarriage is a common event associated with severe psychological and social morbidity, further tormenting in women suffering recurrent pregnancy loss (RPL) by at least three consecutive losses.
Ultrasonography and biomarkers have yet to precisely predict viability in pregnancies with symptoms of threatening miscarriage.
A novel biomarker Preimplantation Factor (PIF) derived by the developing embryo might be the key factor for this prediction ameliorating the implantation process by promoting a favorable local immune system in the uterus.
The investigators aim to establish a prospective early pregnancy cohort (PEP-cohort) that includes women throughout the first trimester by both assisted reproductive technology (ART) and spontaneous conceptions. By a combination of consecutive ultrasonographys and blood samples of known predictors of implantation PIF as a predictor of viability will be evaluated.
These data are finally compared to the same data in a retrospective cohort of RPL patients emphasizing the role of PIF.
All collected data will be stored in a Research Biobank for the current studies outlined as well as potential future studies of reproductive medicine in the first trimester.
详细描述
The investigators aim to evaluate Preimplantation Factor (PIF) throughout the first trimester we need to employ two settings of recruitment.
Early part:
The PEP in ART (PEP-A) will enroll participants referred for fertility treatment at Rigshospitalet and North Zealand Hospital. Participants all have cryopreserved embryos suitable for frozen embryo transfer in a natural menstrual cycle. No type of ovulation trigger will be employed, as the LH peak is monitored via home urine-LH test.
For a thorough examination of the luteal phase, participants are recalled for blood samples on day 7, 11, 14 and 16 after positive urine-LH test. Hereafter positive serum human chorionic gonadotropin (hCG) denotes a pregnancy and these participants are offered to continue in the later part of the PEP-cohort.
Late part:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women in ART treatment by natural cycle frozen embryo transfer only monitored by urine LH.
- •Age above 18 years.
- •Ability to understand read and write Danish for the informed consent.
- •Planned delivery at the hospitals involved in the project.
排除标准
- •Abnormal uterine anatomy or function already known or estimated at first transvaginal ultrasonography.
- •History of recurrent pregnancy loss.
- •Ongoing or former (at least 12 months of no use) narcotics or alcohol abuse (above 14 units of alcohol per week).
- •Contraindication for pregnancy.
- •Inclusion Criteria:
- •Spontaneous pregnancy in women above 18 years of age.
- •Gestational age of singleton pregnancy below full eight weeks by first transvaginal ultrasound.
- •Ability to understand read and write Danish for the informed consent.
- •Planned delivery at the hospitals involved in the project.
- •Exclusion Criteria:
- •All types of ART treatment in the actual pregnancy.
- •Abnormal uterine anatomy or function already known or estimated at first transvaginal ultrasonography.
- •History of recurrent pregnancy loss.
- •Ongoing or former (at least 12 months of no use) narcotics or alcohol abuse (above 14 units of alcohol per week).
- •Contraindication for pregnancy.
结局指标
主要结局
Prediction model for the risk of spontaneous abortion
时间窗: During 2018
The ability of serum PIF to predict viability of natural pregnancies with and without other biomarkers, ultrasonographys and medical history data.
PIF and recurrent pregnancy loss (RPL)
时间窗: Late 2018
Serum PIF levels in a unique retrospective cohort of RPL patients
PIF in PEP-A
时间窗: During 2018
Serum PIF by gestational age in the luteal phase
次要结局
- Hormonal development in the luteal phase(During 2018)
研究者
Jesper Friis Petersen
M.D., PhD student
Nordsjaellands Hospital