Official Title
The Effects and Underlying Mechanisms of Novel Coronavirus Infection on Reproductive Function and Assisted Pregnancy Outcome
Brief Summary

This study aims to observe the impact of COVID-19 infection on the reproductive functionand assisted pregnancy outcome of infertile couples undergoing assisted reproductivetechnology and to determine which factors are related to the clinical pregnancy rate. Amulticenter, prospective, observational cohort study was adopted. Infertile couples whomet the selection criteria were included in this study, the SAS anxiety self-rating scalewas filled out, the basic situation was observed, and blood samples and related tissueswere collected for testing. Relevant reproductive function, laboratory, clinical, andpsychological indicators were collected, and the correlation between the above indicatorsand 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.

Unknown status
Covid-19 Infection

Other: no intervention

no intervention

Eligibility Criteria

Inclusion Criteria:

- Diagnosed with infertility

Exclusion Criteria:

- Patients with contraindications to pregnancy or assisted reproductive technology

Eligibility Gender
All
Eligibility Age
Minimum: 20 Years ~ Maximum: 42 Years
Countries
China
Locations

Department for Reproductive Medicine, Jinling Hospital
Nanjing, Jiangsu, China

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

Contacts

Bing Yao, PHD
025-80864609
yaobing@nju.edu.cn

Li Chen, PHD
025-80864609
872276095@qq.com

Jinling Hospital, China
NCT Number
Keywords
Covid-19
Reproductive function
Sustained pregnancy rate
MeSH Terms
Infections
Communicable Diseases
COVID-19
Coronavirus Infections