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临床试验/CTRI/2022/06/043228
CTRI/2022/06/043228已完成不适用

Quality of life in infertile individual / couple with poor ovarian reserve requiring donor oocytes and its related factors attending infertility clinic- A multi-centric cross-sectional study

Indira IVF Hospital Private Limited10 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2022年6月13日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
210
试验地点
10
主要终点
Quality of life among the infertile individual / couple

研究概览

简要总结

According to a substantial body of literature, infertility negatively affects QoL and appears to lead to mental problems, such as anxiety, depression, frustration, isolation, disturbed identity, and lack of attraction [4,5]. A few studies have investigated QoL in infertile individual / couple with non-specific questionnaires, such as the World Health Organization Quality of Life form (WHOQOLBREF) and Health Survey Short Form (SF-36). A few studies used the Fertility QoL (FertiQol) questionnaire as a fertility-specific QoL assessment of infertile individuals.

Objectives- Â·            To determine the quality of life among the infertile individual / couple attending Indira IVF centers at designated sites as mentioned.

·            To find out the association of poor quality of life with different socio-demographic, medical, and personal characteristics of infertile individual / couple.

Rationale            Until now, few studies have investigated factors that impact QoL in infertile individual / couple. Of particular importance is how the factors that predict QoL vary               couplesin different infertile populations. Recognition of these associated factors is essential for program planning to increase the QoL of the infertile population.Study Outcome            Quality of life among the infertile individual / couple                                   Factors influencing the poor quality of life among infertile individual / coupleHypothesis            We hypothesize that the quality of life among infertile individual / couple will be low.STUDY DESIGN

Description of the Study Design-A multicentric facility-based cross-sectional study.Study Tool-A semi-structured, pretested questionnaire will be used for data collection. The necessary modification will be incorporated into the questionnaire after pretesting. 

Data collection: Data collectors will be identified and trained at each selected center for data capture. Written informed consent will be taken explaining the purpose of the study before administering the questionnaire. The questionnaire’s digital format will be developed in both languages using the Microsoft forms platform for easy capture and clean data collection.Study Population

All the infertile couples attending in-vitro fertilization centers for their treatment will be our study population.

Study SitesFor 10 study site

Duration of study Jan 2022 to June 2022(6 months)

研究设计

研究类型
Observational

入排标准

年龄范围
25.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • All the infertile individuals or couple attending in-vitro fertilization centers and giving consent
  • Women with poor ovarian reserve AFC<5, AMH< 0.5ngm/dl.
  • Patients between 25-45 years of age.

排除标准

  • 1.More than 45 years of age
  • Terminal stage of illness such as cancer, HIV-AIDS, transplant patients, etc.
  • COVID-19 disease.

结局指标

主要结局

Quality of life among the infertile individual / couple

时间窗: At the time of the interview during first week

次要结局

  • Factors influencing the poor quality of life among infertile individual / couple.(At the time of interview in first week of visit)

研究者

发起方
Indira IVF Hospital Private Limited
申办方类型
Research institution and hospital

研究点 (10)

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