Infertility
Conditions
Brief summary
The primary purpose of the study is to investigate the relationship between different protocols of assisted reproductive technology and the epigenetic safety of the offspring. Different interventions of assisted reproductive technology include controlled ovarian hyperstimulation (COH), in vitro embryo culture, in vitro fertilization(IVF), intracytoplasmic sperm injection(ICSI), frozen-thawed embryo transfer(FET), preimplantation genetic testing(PGT). The investigators are also interested in the relationship between pregnancy outcomes in ART or natural conception and environmental, nutritional and lifestyle factors.
Interventions
Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.
Sponsors
International Peace Maternity and Child Health Hospital
Changhai Hospital
Women's Hospital School Of Medicine Zhejiang University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Couples undergoing treatment for infertility or getting pregnant naturally and wanting to deliver their babies in Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity & Child Health Hospital, and Changhai Hospital of Shanghai. 2. Men 22-55 years old 3. Women 20 - 45 years old
Exclusion criteria
1. Any individual or couple who is outside of age range . 2. Any couple who don't plan to complete their pregnancy check-up or deliver their babies in Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity & Child Health Hospital, or Changhai Hospital of Shanghai.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of mental diseases and metabolic dysfunction | 4 years after delivery | — |
| birth weight | 1 day after delivery | Weight of newborns at delivery. |
| implantation rate | 11-12 weeks after embryo transfer | Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age. |
| clinical pregnancy rate | 6 weeks after embryo transfer | Clinical pregnancy was defined as an observation of gestational sac via ultrasonography. |
| congenital anomalies rate | 1 day after delivery | Congenital anomaly included deformity and development abnormality of any organs or systems. |
| weight | Change from the date of delivery up to 4 years after delivery | the weight of offspring |
| height | Change from the date of delivery up to 4 years after delivery | the height of offspring |
| live birth rate | 1 day after delivery | Number of women with live births / number of women randomized to the specific group.Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pregnancy loss rate | 28 gestational weeks in maximum | Pregnancy loss is defined as any reason that resulted in failure of an embryo to develop, embryonic or fetal death, or spontaneous expulsion of a pregnancy. |
| ectopic pregnancy rate | 12 gestational weeks in maximum | Ectopic pregnancy is defined as an embryo implanted outside the uterine. |
| preterm birth rate | 28 gestational weeks to 37 gestational weeks | preterm birth is defined as gestational weeks between 28 to 37. |
| Incidence of moderate to severe ovarian hyperstimulation syndrome(OHSS) | 3 months after controlled ovarian hyperstimulation | Number of cycles of moderate to severe OHSS/total number of fresh stimulation cycle. |
| neonatal complication rate | 1 day after delivery | Neonatal complication includes neonatal respiratory disorders, neonatal cerebral palsy, neonatal encephalopathy and other disease that should been sent into neonatal ICU. |
| biochemical pregnancy rate | 2 weeks after embryo transfer | Biochemical pregnancy is defined as numbers of women with an elevated serum β-hCG level of more than 10 mIU/ml. |
Countries
China
Contacts
Primary ContactDan Zhang, M.D, Ph.D
Outcome results
None listed