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NCT05685966 | RECRUITING | COVID-19


Retrospective Study of COVID-19 on Reproductive Function
Sponsor:

Jinling Hospital, China

Information provided by (Responsible Party):

Bingyao

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

COVID-19

Intervention/treatment

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 Type : OBSERVATIONAL
Estimated Enrollment : 400 participants
Official Title : Retrospective Study of COVID-19 on Reproductive Function and Assisted Reproductive Technology Pregnancy Outcome in China
Actual Study Start Date : 2023-01-20
Estimated Primary Completion Date : 2023-03-30
Estimated Study Completion Date : 2024-01-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 20 Years to 42 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

Retrospective Study of COVID-19 on Reproductive Function

Location Details

NCT05685966


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Locations


RECRUITING

China, Jiangsu

Department for Reproductive Medicine, Jinling Hospital

Nanjing, Jiangsu, China,

RECRUITING

China, Jiangsu

Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital

Nantong, Jiangsu, China,

RECRUITING

China, Jiangsu

Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital

Xuzhou, Jiangsu, China,

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