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临床试验/NCT05562479
NCT05562479已完成不适用

Effect of Sars-cov-2 on Donor Oocyte Quality and Quantity, a Multicenter Retrospective Study.

Novafem1 个研究点 分布在 1 个国家目标入组 428 人开始时间: 2021年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Novafem
入组人数
428
试验地点
1
主要终点
MII mature oocytes after retrieval

研究概览

简要总结

Purpose: To determine the impact of SARS-CoV-2 infection and immunization on ovarian response to controlled ovarian stimulation (COS) and embryo development after in vitro fertilization (IVF) Methods: A retrospective multicentric cohort study of 427 oocyte donors was conducted between January 1st, 2018 and September 18th, 2022. Patients who recovered from SARS-CoV-2 infection, vaccinated or non-exposed were included. Demographic, cycle characteristics, and laboratory outcomes were compared.

详细描述

This was a multicenter retrospective cohort study performed at the Centro de Fertilidad y Genetica Novafem, Bogota, Colombia, and Clinica de la Mujer - Medicina Reproductiva, Viña del Mar, Chile. The Ethics Committee approved the study protocol of both centers. Informed contents were obtained from patients for data collection with scientific use.

All donors who underwent COS for oocyte donation between January 1st, 2018 and July 31th, 2022 were screened for eligibility and followed up to September 18th, 2022.

Oocyte donation cycles were utilized because this model is an excellent choice for controlling known female characteristics. Previous research concluded that a major predictor of ART outcomes is maternal age.

Eligibility criteria were donors aged older than 18 years or younger than 35 years. After providing informed consent, the patients were questioned about their confirmed past SARS-Cov-2 infection/vaccination status. Patients were categorized into the vaccinated group if they had received two dosages of any SARS-CoV-2 vaccines (BNT162b2 mRNA Pfizer-Biontech, mRNA-1273 Moderna or inactivated SARS-CoV-2 vaccine Sinovac) with a break of at least three weeks between each dose. First and second vaccine dates were requested of vaccinated patients. Vaccine administration details, such as vaccine type, dose, date, manufacturer, and lot number, were collected from immunization records.

For recovering patients, the date of a negative nasopharyngeal COVID polymerase chain reaction (PCR) test was registered. None of the recovering patients were vaccinated with any SARS-CoV-2 vaccine. Both clinics strictly required a negative PCR test for SARS-CoV-2 RNA detection 5 days before oocyte retrieval, except for those patients who were less than 3 months following recovery from SARS-Cov-2 infection. Patients in the control group were selected from medical records prior to March 2020 to ensure they did not have the infection and were not vaccinated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 32 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

MII mature oocytes after retrieval

时间窗: 2018 to 2022

Fertilization rate

时间窗: 2018 to 2022

Blastocyst rate formation

时间窗: 2018 to 2022

次要结局

  • antral follicular count before retrieval(2018 to 2022)

研究者

发起方
Novafem
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Pablo Saffon

Director

Novafem

研究点 (1)

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