Retrospective Study of COVID-19 on Reproductive Function

Sponsor
Jinling Hospital, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT05685966
Collaborator
(none)
400
3
12.3
133.3
10.8

Study Details

Study Description

Brief Summary

This multi-center, retrospective cohort study aimed to determine which factors are associated with ongoing pregnancy rates in infertile patients received ART treatments during the current outbreak of COVID-19 infection.Couples who underwent IVF-ET/ICSI-ET/FET due to infertility in the department of Reproductive Medicine from 2022-11-23 to 2023-01-07 were included. Patients who were infected with Coronavirus were observation groups; the infection status and clinical outcome were tracked. Patients who were not infected with Coronavirus were control groups.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

Detailed Description

In this multi-center, retrospective cohort study, we included patients who underwent IVF-ET/ICSI-ET/FET due to infertility in the department of Reproductive Medicine from 2022-11-23 to 2023-01-07. Patients who were infected with Coronavirus were observation groups; the infection status and clinical outcome were tracked. Patients who were not infected with Coronavirus were control groups. We compared different parameters between two groups. The primary outcome was ongoing pregnancy rate. Basic information about patients' menstruation, sexual desire, and sexual function were collected from Medical record system. Other information about patients' vaccination status, symptoms related to viral infection were collected by telephone follow ups. Susceptibility indicators to COVID-19 infection including fasting blood glucose, insulin, blood lipids, alpha-function, renin-angiotensinase, I-aldosterone were obtained . 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 also collected . Assisted pregnancy outcome: clinical pregnancy rate, embryo implantation rate, early abortion rate, ongoing pregnancy rate, and other clinical indicators were analyzed to determine whether there is deference in clinical outcomes between two groups.

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Retrospective Study of COVID-19 on Reproductive Function and Assisted Reproductive Technology Pregnancy Outcome in China
Actual Study Start Date :
Jan 20, 2023
Anticipated Primary Completion Date :
Mar 30, 2023
Anticipated Study Completion Date :
Jan 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Infertile couples from the research center who visited for fertility disorders

Infertile couples infected or not infected with COVID-19 were included.This is an observational study with no interventions.

Other: no intervention
no intervention

Outcome Measures

Primary Outcome Measures

  1. Ongoing pregnancy rate [3 months]

    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

  1. Clinical and laboratory indicators related to male and female reproductive function [3 months]

    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

  2. Outcome indicators of assisted pregnancy [3 months]

    Embryo implantation rate, early abortion rate, ongoing pregnancy rate, incidence of OHSS

Other Outcome Measures

  1. Coagulation index [3 months]

    D-dimer

  2. Indicators of susceptibility to COVID-19 infection [3 months]

    blood lipid, blood sugar, insulinand thyroid function

  3. Oxidative stress index [3 months]

    fingertip pulse oxygen saturation

  4. SAS Anxiety Scale [3 months]

    SAS Anxiety Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 42 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosed with infertility

  • Patients with IVF-ET/ICSI-ET/FET from 2022/11/23 to 2023/01/07

Exclusion Criteria:
  • Patients with contraindications to pregnancy or assisted reproductive technology

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department for Reproductive Medicine, Jinling Hospital Nanjing Jiangsu China
2 Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital Nantong Jiangsu China
3 Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital Xuzhou Jiangsu China

Sponsors and Collaborators

  • Jinling Hospital, China

Investigators

  • Study Chair: Bing Yao, PHD, Department of Reproductive Medicine, Jinling Hospital
  • Study Director: Li Chen, PHD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Xiaojie Huang, PHD, Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital
  • Principal Investigator: Jiayi Ding, PHD, Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital
  • Principal Investigator: Qin Sun, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Meiling Li, PHD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Cheng Zhou, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Xi Chen, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Yuming Feng, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Juanjuan Xu, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Haiyan Fu, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Cencen Wang, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Hong Zhang, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Lu Zheng, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Yuxiu Liu, PHD, Department of Critical Care Medicine, Jinling Hospital
  • Principal Investigator: Xiaofang Tan, MD, Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital
  • Principal Investigator: Yunxia Zhu, MD, Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital
  • Principal Investigator: Jueraitetibaike Kadiliya, PHD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Zhichan Zou, MD, Department of Reproductive Medicine, Jinling Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bing Yao, Professor, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT05685966
Other Study ID Numbers:
  • Retrospective study of COVID19
First Posted:
Jan 17, 2023
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bing Yao, Professor, Jinling Hospital, China
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2023