Clinical trial NCT05685992: Novel Coronavirus Infection and Reproductive Function
Official title: The Effects and Underlying Mechanisms of Novel Coronavirus Infection on Reproductive Function and Assisted Pregnancy Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Infection
Keywords: COVID-19
Reproductive function
Sustained pregnancy rate
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Failure to establish a clinical pregnancy after 12 months of regular unprotected intercourse, or due to impaired fertility of the individual or his or her partner, is termed infertility.

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with infertility

Exclusion Criteria:

* Patients with contraindications to pregnancy or assisted reproductive technology

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 1 year
Secondary outcomes:
measure: Clinical and laboratory indicators related to male and female reproductive function
timeFrame: 1 year
measure: Outcome indicators of assisted pregnancy
timeFrame: 1 year
Other outcomes:
measure: Coagulation index
timeFrame: 1 year
measure: Indicators of susceptibility to COVID-19 infection
timeFrame: 1 year
measure: Oxidative stress index
timeFrame: 1 year
measure: SAS Anxiety Scale
timeFrame: 1 year
Locations:
city: Nanjing
country: China
facility: Department for Reproductive Medicine, Jinling Hospital
state: Jiangsu
city: Nantong
country: China
facility: Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Department of Reproductive Medicine, Jinling Hospital
name: Bing Yao, PHD
role: STUDY_CHAIR
affiliation: Department of Reproductive Medicine, Jinling Hospital
name: Li Chen, PHD
role: STUDY_DIRECTOR
affiliation: Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital
name: Xiaojie Huang, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital
name: Jiayi Ding, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Jinling Hospital
name: Qin Sun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Jinling Hospital
name: Meiling Li, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Jinling Hospital
name: Cheng Zhou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Jinling Hospital
name: Xi Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Jinling Hospital
name: Yuming Feng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Jinling Hospital
name: Juanjuan Xu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Jinling Hospital
name: Haiyan Fu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Jinling Hospital
name: Cencen Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Jinling Hospital
name: Hong Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Jinling Hospital
name: Lu Zheng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Critical Care Medicine, Jinling Hospital
name: Yuxiu Liu, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital
name: Xiaofang Tan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital
name: Yunxia Zhu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Jinling Hospital
name: Jueraitetibaike Kadiliya, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Jinling Hospital
name: Zhichan Zou, MD
role: PRINCIPAL_INVESTIGATOR
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