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A Retrospective Cohort Study on the Impact of Painless Oocyte Retrieval Versus Non-Anesthetic Oocyte Retrieval on Assisted Reproductive Outcomes

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注册号：

Registration number：

ChiCTR2600126899 

最近更新日期：

Date of Last Refreshed on：

2026-06-18 14:39:22 

注册时间：

Date of Registration：

2026-06-18 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

无痛取卵与非麻醉下取卵对辅助生殖结局影响的回顾性队列研究

Public title：

A Retrospective Cohort Study on the Impact of Painless Oocyte Retrieval Versus Non-Anesthetic Oocyte Retrieval on Assisted Reproductive Outcomes

注册题目简写：

English Acronym：

研究课题的正式科学名称：

无痛取卵与非麻醉下取卵对辅助生殖结局影响的回顾性队列研究

Scientific title：

A Retrospective Cohort Study on the Impact of Painless Oocyte Retrieval Versus Non-Anesthetic Oocyte Retrieval on Assisted Reproductive Outcomes

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

任力 

研究负责人：

任力 

Applicant：

Ren Li 

Study leader：

Ren Li 

申请注册联系人电话：

Applicant telephone：

+86 18323187421

研究负责人电话：

Study leader's telephone：

+86 23 8901 1069

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

renli177@163.com

研究负责人电子邮件：

Study leader's E-mail：

renli177@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

重庆市渝中区袁家岗友谊路1号

研究负责人通讯地址：

重庆市袁家岗友谊路1号

Applicant address：

No. 1 Youyi Road, Yuanjiagang, Yuzhong District, Chongqing, China

Study leader's address：

1st You Yi Road, Yu Zhong District, Chongqing , China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

重庆医科大学附属第一医院

Applicant's institution：

The First Affiliated Hospital of Chongqing Medical University

研究负责人所在单位：

重庆医科大学附属第一医院

Affiliation of the Leader：

The First Affiliated Hospital of Chongqing Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2026年科研伦审(2026-0470-01)

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

重庆医科大学附属第一医院医学研究伦理审查委员会

Name of the ethic committee：

Medical Research Ethics Review Committee of the First Affiliated Hospital of Chongqing Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2026-06-08 00:00:00

伦理委员会联系人：

严青

Contact Name of the ethic committee：

Yan Qing

伦理委员会联系地址：

重庆市袁家岗友谊路1号

Contact Address of the ethic committee：

1st You Yi Road, Yu Zhong District, Chongqing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 23 89011876

伦理委员会联系人邮箱：

Contact email of the ethic committee：

444158752@qq.com

研究实施负责（组长）单位：

重庆医科大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Chongqing Medical University

研究实施负责（组长）单位地址：

重庆市袁家岗友谊路1号

Primary sponsor's address：

1st You Yi Road, Yu Zhong District, Chongqing 400016, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

重庆市

市(区县)：

Country：

China

Province：

Chongqing

City：

单位(医院)：

重庆医科大学附属第一医院

具体地址：

重庆市袁家岗友谊路1号

Institution
hospital：

The First Affiliated Hospital of Chongqing Medical University

Address：

1st You Yi Road, Yu Zhong District, Chongqing 400016, China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

No external funding

Target disease：

female infertility

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

（一）主要研究目的：本研究旨在基于回顾性队列设计，比较无痛取卵与非麻醉下取卵两种不同取卵方式对辅助生殖结局的影响，重点评估其对新生儿或胚胎不良事件发生率的影响差异。该主要结局为复合结局指标，涵盖胚胎发育异常（包括异常受精、胚胎发育停滞、胚胎质量下降及胚胎植入前遗传学检测异常等）、妊娠相关不良结局（包括生化妊娠、流产、胎停育、异位妊娠及死胎等）以及新生儿不良结局（包括早产、低出生体重、小于胎龄儿、新生儿窒息、新生儿重症监护室入住情况、新生儿死亡及先天性畸形等），用于综合评价不同取卵方式对胚胎发育、妊娠维持及围产结局的整体影响。研究将结合患者人口学特征、卵巢储备功能、既往生育及辅助生殖史、合并疾病情况及促排卵方案等基线资料，对主要结局进行多因素校正分析，以控制潜在混杂因素的影响，从而客观评估不同取卵方式的安全性差异。 （二）次要研究目的：1.评估无痛取卵与非麻醉下取卵对卵母细胞质量及卵巢反应的影响，包括获卵数及获卵率、成熟卵母细胞数及成熟率、未成熟卵母细胞比例、卵母细胞形态学特征以及卵泡液相关生化指标等。2.比较两种取卵方式对胚胎发育能力的影响差异，包括正常受精率、异常受精率、卵裂率、优质胚胎率、囊胚形成率及可移植/可冻存胚胎数等胚胎学指标。3.分析不同取卵方式对临床妊娠结局的影响，包括临床妊娠率、生化妊娠率、持续妊娠率、流产率及活产率，并进一步评估早产率、新生儿出生体重、先天性畸形发生率及新生儿疾病筛查异常率等围产结局指标。4.进行分层及亚组分析，基于患者年龄、卵巢储备功能、促排卵方案类型、移植周期类型（新鲜周期或冻融周期）及胚胎移植阶段（卵裂期或囊胚期）等因素，探讨不同人群中取卵方式对结局影响的差异性。  

Objectives of Study：

Main Research Objective: This study aims, based on a retrospective cohort design, to compare the effects of painless egg retrieval and egg retrieval without anesthesia on assisted reproduction outcomes. The focus is on evaluating differences in the incidence of adverse events in newborns or embryos. The primary outcome is a composite indicator covering embryonic development abnormalities (including abnormal fertilization, embryonic developmental arrest, decreased embryo quality, and preimplantation genetic testing abnormalities), pregnancy-related adverse outcomes (including biochemical pregnancy, miscarriage, fetal demise, ectopic pregnancy, and stillbirth), and neonatal adverse outcomes (including preterm birth, low birth weight, small for gestational age, neonatal asphyxia, NICU admission, neonatal death, and congenital malformations). This composite measure is used to comprehensively evaluate the overall impact of different egg retrieval methods on embryo development, pregnancy maintenance, and perinatal outcomes. The study will take into account patients' demographic characteristics, ovarian reserve, past fertility and assisted reproductive history, comorbidities, and ovulation stimulation protocols for multivariate adjustment of the primary outcome to control for potential confounders, thereby objectively assessing the safety differences between the two egg retrieval methods. Secondary Research Objectives: 1. To evaluate the effects of painless egg retrieval and egg retrieval without anesthesia on oocyte quality and ovarian response, including the number of oocytes retrieved and retrieval rate, the number and maturation rate of mature oocytes, the proportion of immature oocytes, oocyte morphological features, and follicular fluid biochemical markers. 2. To compare the impact of the two retrieval methods on embryo developmental potential, including normal fertilization rate, abnormal fertilization rate, cleavage rate, high-quality embryo rate, blastocyst formation rate, and the number of embryos available for transfer or freezing. 3. To analyze the effects of different egg retrieval methods on clinical pregnancy outcomes, including clinical pregnancy rate, biochemical pregnancy rate, ongoing pregnancy rate, miscarriage rate, and live birth rate, and further assess perinatal outcomes such as preterm birth rate, neonatal birth weight, incidence of congenital malformations, and abnormal neonatal screening results. 4. To conduct stratified and subgroup analyses based on factors such as patient age, ovarian reserve, type of ovulation stimulation protocol, type of transfer cycle (fresh or frozen), and embryo transfer stage (cleavage or blastocyst stage), to explore differences in outcome effects among different populations.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄18～45岁；
2.在本中心接受经阴道超声引导下取卵术；
3.取卵当天镇痛/麻醉方式记录明确，可判定为无痛取卵组或无麻醉下取卵组；
4.具有完整或基本完整的取卵数据、卵母细胞质量评价、胚胎发育评价和临床妊娠结局等随访资料；
5.患者诊疗数据可通过医院电子病历系统、生殖中心数据库、手术麻醉系统等方式进行追溯。

Inclusion criteria

1. Age between 18 and 45 years;
2.Underwent transvaginal ultrasound-guided oocyte retrieval at our center;
3.The analgesia/anesthesia method on the day of oocyte retrieval was clearly documented and could be classified as either the painless oocyte retrieval group or the non-anesthetic oocyte retrieval group;
4.Availability of complete or substantially complete follow-up data, including oocyte retrieval data, oocyte quality assessment, embryo development assessment, and clinical pregnancy outcomes;
5.Patient clinical data could be retrieved through the hospital electronic medical record system, reproductive medicine database, surgical anesthesia system, and other relevant sources.

排除标准：

1.数据不完整或缺失关键指标：无法确认取卵时镇痛/麻醉方式；缺少关键结果数据，如获卵数、卵母细胞质量、胚胎发育数据、临床妊娠结局等；电子病历、麻醉记录或生殖中心数据库无法追溯；
2.严重并发症影响结果：取卵术中出现严重手术并发症，如卵巢穿刺失败、术中大出血等；
3.取卵过程中使用非规范麻醉/镇痛方案，难以归类到无痛取卵组或无麻醉下取卵组。

Exclusion criteria：

1. Incomplete data or missing key variables: inability to determine the analgesia/anesthesia method used during oocyte retrieval；missing key outcome data, including the number of oocytes retrieved, oocyte quality, embryo development data, clinical pregnancy outcomes, etc.or inability to retrieve records from the electronic medical record system, anesthesia records, or reproductive medicine database;
2. Severe complications affecting outcomes: occurrence of serious intraoperative complications during oocyte retrieval, such as failed ovarian puncture or major intraoperative bleeding;
3. Use of non-standard anesthesia/analgesia protocols during oocyte retrieval, making it difficult to classify patients into either the painless oocyte retrieval group or the non-anesthetic oocyte retrieval group.

研究实施时间：

Study execute time：

从 From 2026-07-01 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-07-01 00:00:00 至 To 2027-12-31 00:00:00  

干预措施：

Interventions：

组别：

无痛取卵组

样本量：

1450

Group：

Painless oocyte retrieval group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

非麻醉下取卵组

样本量：

1450

Group：

Non-anesthetic oocyte retrieval group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆市 

市(区县)：

  

Country：

China 

Province：

Chongqing 

City：

 

单位(医院)：

重庆医科大学附属第一医院 

单位级别：

三级甲等 

Institution
hospital：

The First Affiliated Hospital of Chongqing Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

新生儿或胚胎不良事件发生率

指标类型：

主要指标

Outcome：

Incidence of neonatal or embryo adverse events

Type：

Primary indicator

测量时间点：

自受精至新生儿随访结束

测量方法：

本研究采用复合结局指标进行评价。通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据。若研究周期内发生任一预定义胚胎、妊娠或新生儿不良事件，则定义为发生新生儿或胚胎不良事件，从而计算新生儿或胚胎不良事件发生率。

Measure time point of outcome：

From fertilization to completion of neonatal follow-up

Measure method：

This study used composite outcome indicators for evaluation. Relevant data were extracted through the hospital electronic medical record system, the reproductive center database, the embryo laboratory record and the follow-up system. If any predefined embryo, pregnancy or neonatal adverse events occurred during the study period, it was defined as the occurrence of neonatal or embryonic adverse events, so as to calculate the incidence of neonatal or embryonic adverse events.

指标中文名：

获卵率

指标类型：

次要指标

Outcome：

oocyte retrieval rate

Type：

Secondary indicator

测量时间点：

取卵术后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

after oocyte retrieval

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

新生儿疾病筛查异常率

指标类型：

次要指标

Outcome：

Abnormal rate of neonatal disease screening

Type：

Secondary indicator

测量时间点：

分娩后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

after delivery

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

胚胎移植类型

指标类型：

次要指标

Outcome：

Type of embryo transfer

Type：

Secondary indicator

测量时间点：

受精后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

postfertilization

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

可用囊胚数

指标类型：

次要指标

Outcome：

Available blastocyst number

Type：

Secondary indicator

测量时间点：

受精后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

postfertilization

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

获卵数

指标类型：

次要指标

Outcome：

retrieved oocyte number

Type：

Secondary indicator

测量时间点：

取卵术后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

after oocyte retrieval

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

流产率

指标类型：

次要指标

Outcome：

abortion ratio

Type：

Secondary indicator

测量时间点：

胚胎移植后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

After embryo transfer

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

卵裂数和率

指标类型：

次要指标

Outcome：

The number and rate of embryo cleavage

Type：

Secondary indicator

测量时间点：

受精后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

postfertilization

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

MII期卵母细胞率

指标类型：

次要指标

Outcome：

The rate of MII oocyte

Type：

Secondary indicator

测量时间点：

取卵术后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

after oocyte retrieval

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

正常受精数和率

指标类型：

次要指标

Outcome：

The number and rate of Normal fertilization

Type：

Secondary indicator

测量时间点：

受精后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

postfertilization

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

卵母细胞形态

指标类型：

次要指标

Outcome：

oocyte morphology

Type：

Secondary indicator

测量时间点：

取卵术后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

after oocyte retrieval

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

早产率

指标类型：

次要指标

Outcome：

premature delivery rate

Type：

Secondary indicator

测量时间点：

胚胎移植后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

After embryo transfer

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

临床妊娠率

指标类型：

次要指标

Outcome：

clinical pregnancy rate

Type：

Secondary indicator

测量时间点：

胚胎移植后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

After embryo transfer

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

新生儿体重

指标类型：

次要指标

Outcome：

birth weight

Type：

Secondary indicator

测量时间点：

分娩后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

after delivery

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

持续妊娠率

指标类型：

次要指标

Outcome：

ongoing pregnancy rate

Type：

Secondary indicator

测量时间点：

胚胎移植后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

After embryo transfer

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

生化妊娠率

指标类型：

次要指标

Outcome：

biochemical pregnancy rate

Type：

Secondary indicator

测量时间点：

胚胎移植后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

After embryo transfer

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

新生儿先天性畸形率

指标类型：

次要指标

Outcome：

the rate of neonatal congenital malformation

Type：

Secondary indicator

测量时间点：

分娩后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

after delivery

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

优质胚胎数和率

指标类型：

次要指标

Outcome：

The number and rate of high-quality embryos

Type：

Secondary indicator

测量时间点：

受精后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

postfertilization

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

MII期卵母细胞数

指标类型：

次要指标

Outcome：

The number of MII oocyte

Type：

Secondary indicator

测量时间点：

取卵术后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

after oocyte retrieval

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

指标中文名：

囊胚形成数和率

指标类型：

次要指标

Outcome：

The number and rate of blastulation

Type：

Secondary indicator

测量时间点：

受精后

测量方法：

通过医院电子病历系统、生殖中心数据库、胚胎实验室记录及随访系统提取相关数据

Measure time point of outcome：

postfertilization

Measure method：

Relevant data were extracted through the hospital electronic medical record system, reproductive center database, embryo laboratory record and follow-up system.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 45 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

数据采集：本研究数据采集包括病例报告表（Case Report Form，CRF）及电子数据采集系统（Electronic Data Capture，EDC）两部分。研究数据来源于医院电子病历系统、生殖中心数据库、手术麻醉系统、胚胎实验室记录及随访系统。所有数据由研究人员按照统一标准进行提取，并录入加密电子数据库。采用唯一研究编号替代患者身份信息，对患者姓名、住院号、身份证号、联系方式等直接身份信息进行脱敏处理。 数据管理：采用双人核对录入制度，确保数据录入的准确性，定期对数据进行完整性和一致性检查。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data collection and management will consist of Case Report Forms (CRFs) and an electronic data capture (EDC) system. Data will be extracted from electronic medical records, reproductive medicine databases, anesthesia systems, embryology laboratory records, and follow-up systems. All data will be collected according to standardized procedures and entered into a secure database. Participants will be assigned unique study identification numbers, and all identifiable information will be de-identified. Double data verification and regular quality control procedures will be implemented to ensure data accuracy, completeness, and consistency.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-06-18 14:38:58
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