- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05055245
Stress in Couples Undergoing Assisted Reproduction Technology With Different Cycles and Its Impact on Pregnancy Outcomes
14. september 2021 opdateret af: Yimin Zhu, Women's Hospital School Of Medicine Zhejiang University
With the development of assisted reproductive technology (ART), more and more infertile women are obtaining their offspring through assisted reproductive technology.
However, a growing number of national and international studies have shown that infertility patients are prone to negative emotions such as anxiety and depression during ART treatment, which not only affects their physical and mental health, but also affects the embryo implantation rate and pregnancy rate of ART.
The purpose of this study is to investigate the stress faced by participants undergoing ART with different cycles and to further investigate its impact on pregnancy outcomes.
Studieoversigt
Detaljeret beskrivelse
With the rapid social and economic development in recent years, the incidence of infertility has increased significantly due to environmental pollution, poor lifestyle habits and increasing stress in various areas.
According to global statistics, one in six married couples suffers from infertility.
With the development of assisted reproductive technology (ART), more and more infertile women are obtaining their offspring.
In clinical practice, however, a significant proportion of patients undergoing ART have low embryo implantation and pregnancy rates and experience recurrent implantation failure (RIF).
A growing number of national and international studies have shown that infertility patients are prone to negative emotions such as anxiety and depression during ART treatment, which not only affects their physical and mental health, but also affects the embryo implantation rate and pregnancy rate of ART.
This effect is more pronounced in patients with multiple failed transfers.
In this study, investigators intend to investigate the stress faced by participants undergoing assisted reproduction with different cycles to provide a reliable basis for future psychological interventions and health education for this group of patients and improve the quality of life of infertility patients.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
200
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yimin Zhu, Dr.
- Telefonnummer: 057189992071
- E-mail: zhuyim@zju.edu.cn
Studiesteder
-
-
Zhejiang
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Hangzhou, Zhejiang, Kina
- Women's Hospital, School of Medicine, Zhejiang University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år til 40 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients undergoing assisted reproductive technology
Beskrivelse
Inclusion Criteria:
- Female partners' >18< 40 years
- Patients undergoing assisted reproductive technology
Exclusion Criteria:
- Female partners with polycystic ovary
- Female partners with insufficiency or premature ovarian failure
- Female partners with endometriosis
- Female partners with abnormal profile of thyroid hormones
- Chromosomal abnormalities of either spouse
- Mental disorder of either spouse
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Patients undergoing assisted reproductive technology
Patients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)
|
Patients are grouped according to the number of IVF/ICSI cycles.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Implantation rate
Tidsramme: 6 months
|
Implantation rate is defined as number of sacs per embryo transferred.
|
6 months
|
|
clinical pregnancy rate
Tidsramme: 6 months
|
presence of at least one gestational sac on ultrasound of 6 weeks
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Antal udvundne oocytter
Tidsramme: 6 måneder
|
6 måneder
|
|
|
fertilization rate
Tidsramme: 6 months
|
No. of fertilized oocyte divided by No. of inseminated cumulus-oocyte complexes (COCs)
|
6 months
|
|
cleavage rate
Tidsramme: 6 months
|
No. of cleaved embryo divided by No. of fertilized oocyte
|
6 months
|
|
Total gonadotropin use
Tidsramme: 6 months
|
Total gonadotropin use of each participant
|
6 months
|
|
Ovarian hyperstimulation syndrome (OHSS) rates
Tidsramme: 6 months
|
OHSS rates in both study groups
|
6 months
|
|
Metaphase II (MII) oocytes
Tidsramme: 6 months
|
the number of mature oocytes
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Yimin Zhu, Dr., Women's Hospital School of Medicine Zhejiang University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
9. oktober 2021
Primær færdiggørelse (Forventet)
9. marts 2022
Studieafslutning (Forventet)
9. april 2022
Datoer for studieregistrering
Først indsendt
14. september 2021
Først indsendt, der opfyldte QC-kriterier
14. september 2021
Først opslået (Faktiske)
24. september 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. september 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20210914
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