Novel Coronavirus Infection and Reproductive Function
- Conditions
- COVID-19 Infection
- Interventions
- Other: no intervention
- Registration Number
- NCT05685992
- Lead Sponsor
- Jinling Hospital, China
- Brief Summary
This study aims to observe the impact of COVID-19 infection on the reproductive function and assisted pregnancy outcome of infertile couples undergoing assisted reproductive technology and to determine which factors are related to the clinical pregnancy rate. A multicenter, prospective, observational cohort study was adopted. Infertile couples who met the selection criteria were included in this study, the SAS anxiety self-rating scale was filled out, the basic situation was observed, and blood samples and related tissues were collected for testing. Relevant reproductive function, laboratory, clinical, and psychological indicators were collected, and the correlation between the above indicators and the outcome of the ART-related pregnancy were analyzed.
- Detailed Description
In this multicenter, prospective, observational cohort study, we included infertile couples based on inclusion criteria. The couples were asked to fill in the SAS anxiety self-rating scale. Basic information about patients' vaccination status, symptoms related to viral infection, menstruation, sexual desire, and sexual function were obtained. Blood samples of couples were collected on the date of diagnosis, the start date of the fresh cycle during assisted reproductive technology treatment, the day of oocyte retrieval, the day of embryo transfer, the day of 14 days, 35 days after embryo transfer, and the day of 70 days of gestation. Follicular fluid, granulosa cells on the day of oocyte retrieval, and embryo culture fluid on the day of embryo transfer were collected. Blood samples and endometrial tissues were collected five days after oocyte retrieval. Blood samples from the menstrual period, endometrial transformation day, and embryo transfer day of the frozen embryo transfer cycle were also collected. Then C-reactive protein, erythrocyte sedimentation rate, procalcitonin and IL-6, granulocyte-macrophage colony-stimulating factor (GM-CSF), TNF-α, VEGF, and other cytokines and chemokines were determined. In addition, fasting blood glucose, insulin, blood lipids, alpha-function, renin-angiotensinase, I-aldosterone, and other susceptibility indicators to COVID-19 infection were tested. Oxygen saturation, malondialdehyde (MDA), HO-1, and SOD oxidative stress indices of the fingertip pulse were determined. An endometrial receptivity gene chip and proteomics detected endometrial tissue. A panel kit for blood vessel and inflammation indicators detected the abortion decidua tissue. Reproductive function indices AMH, INHB, sex hormones, follicle retrieval rate, Gn days, total Gn, endometrial thickness, the incidence of OHSS, semen quality, oocyte maturation rate, fertilization rate, qualified embryo rate, blastocyst formation rate, and other laboratory indices of both men and women were collected. Assisted pregnancy outcome: clinical pregnancy rate, embryo implantation rate, early abortion rate, ongoing pregnancy rate, and other clinical indicators, as well as psychological indicators such as the SAS anxiety scale, were analyzed to determine the correlation between the above indicators and ART-related pregnancy outcome.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- Diagnosed with infertility
- Patients with contraindications to pregnancy or assisted reproductive technology
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Infertile couples infected or not infected with COVID-19 no intervention Infertile couples infected or not infected with COVID-19 were included.This is an observational study with no interventions.
- Primary Outcome Measures
Name Time Method Ongoing pregnancy rate 1 year If the fetal sac, fetal bud, and primitive fetal heartbeat are found by vaginal B-ultrasound examination 55-65 days after embryo transfer, the diagnosis of ongoing pregnancy will be made.
- Secondary Outcome Measures
Name Time Method Clinical and laboratory indicators related to male and female reproductive function 1 year AMH, INB, sex hormone, follicle output rate, Gn days, total Gn, endometrial thickness on the embryo transfer day, semen quality; Oocyte maturation rate, fertilization rate, high-level embryo rate, blastocyst formation rate
Outcome indicators of assisted pregnancy 1 year Embryo implantation rate, early abortion rate, ongoing pregnancy rate, incidence of OHSS
Trial Locations
- Locations (3)
Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital
🇨🇳Nantong, Jiangsu, China
Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital
🇨🇳Xuzhou, Jiangsu, China
Department for Reproductive Medicine, Jinling Hospital
🇨🇳Nanjing, Jiangsu, China