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Retrospective Study of COVID-19 on Reproductive Function

Retrospective Study of COVID-19 on Reproductive Function and Assisted Reproductive Technology Pregnancy Outcome in China

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05685966
Enrollment
400
Registered
2023-01-17
Start date
2023-01-20
Completion date
2024-01-30
Last updated
2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19, Reproductive function, Sustained pregnancy rate

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.

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.

Interventions

OTHERno intervention

no intervention

Sponsors

Jinling Hospital, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 42 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Ongoing pregnancy rate3 monthsIf 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

MeasureTime frameDescription
Outcome indicators of assisted pregnancy3 monthsEmbryo implantation rate, early abortion rate, ongoing pregnancy rate, incidence of OHSS
Clinical and laboratory indicators related to male and female reproductive function3 monthsAMH, 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

Other

MeasureTime frameDescription
SAS Anxiety Scale3 monthsSAS Anxiety Scale
Indicators of susceptibility to COVID-19 infection3 monthsblood lipid, blood sugar, insulinand thyroid function
Coagulation index3 monthsD-dimer
Oxidative stress index3 monthsfingertip pulse oxygen saturation

Countries

China

Contacts

Primary ContactBing Yao, PHD
yaobing@nju.edu.cn025-80864609
Backup ContactLi Chen, PHD
872276095@qq.com025-80864609

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026