Considering the high prevalence of infertility-related concerns and limited studies on the efficiency of acupuncture in infertility-related stress and IVF outcomes, we conduct this study to determine whether acupuncture affects infertility-related stress in infertile patients, refer to Omme-Leila Infertility Clinic in Bandar Abbas, Iran..
Design
Two parallel groups with randomized trial with pretest-posttest andevaluation.
Settings and conduct
This quasi-experimental study had a pretest-posttest control-group design. The statistical population included all infertile patients in the age range of 25-45 years under IVF treatment at Omme-Leila Infertility Clinic during 2018. A total of 120 patients were randomly divided into either the case or control group (60 patients per group) via convenience sampling. Data were collected by distributing questionnaires among patients before and after acupuncture and 35 minutes before embryo transfer
Participants/Inclusion and exclusion criteria
The inclusion criteria for this study are all female patients referring to the Bandar Abbas Omme- leila clinic between 25-45 years old . Patients under 25 years old and over 45 years old and rare diseases patients are not include from this study.
Intervention groups
The data were collected by distributing Newton questionnaire in control group 35 minutes before embryo transfer.
Main outcome variables
This study impacts acupuncture on
1- social concerns;
2- sexual concerns;
3- relationship concerns;
4- need for parenting;
5- childless lifestyle;
referring to Bandar Abbas Omme- Leila Infertility Clinic for IVF.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200202046336N1
Registration date:2020-03-08, 1398/12/18
Registration timing:retrospective
Last update:2020-03-08, 1398/12/18
Update count:0
Registration date
2020-03-08, 1398/12/18
Registrant information
Name
Kobra Haji Alizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3367 0255
Email address
ph_alizadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
2018-10-23, 1397/08/01
Actual recruitment end date
2019-01-21, 1397/11/01
Trial completion date
2019-02-20, 1397/12/01
Scientific title
The Effects of Acupuncture on Infertility-related Stress and In Vitro Fertilization (IVF) Outcomes
Public title
The effect of acupuncture on reducing infertility stress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
َAll infertile women between 25-45 years old, who were referred to Omme-Leila Infertility Clinic in Bandar Abbas, Iran, in 2018.
Exclusion criteria:
People with rare diseases are not include in this study,
Age
From 25 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
133
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Our considered sample size is 120 (with 60 people in each group). Block randomization method will be designed by using randomization list and Individuals will be placed in the 6-block blocks in the order of days. 60patients are in intervention group (5 groups of 8-12 patients as entering in to the study) and 60 patients in control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Islamic Azad University of Bandar Abbas,Daneshgah BLV, Golshahr
City
Bandar Abbas
Province
Hormozgan
Postal code
7915899143
Approval date
2018-10-14, 1397/07/22
Ethics committee reference number
IR.HUMS.REC.1397.221
Health conditions studied
1
Description of health condition studied
This study investigates the impact of acupuncture on infertility stress
ICD-10 code
Z31.2
ICD-10 code description
in vitro fertilization
Primary outcomes
1
Description
The primary outcome variable in this study is the rate of stress reduction in infertile patients (25-45 years old) referred to Omme-Leila clinic .
Timepoint
Acupuncture is performed 35 minutes before embryo transfer.
Method of measurement
Newton Infertility Stress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Patients complete the Newton questionnaire after training, then they receive acupuncture treatment services, and after that patients complete the questionnaire again. After 35 minutes the embryo is transferred.
Category
Treatment - Other
2
Description
Control group:35 minutes before embryo transfer, the control group completed the Newton questionnaire.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Omme-leila Infertility Clinic
Full name of responsible person
Zahra Khashavi
Street address
Omme-leila Hospital, Omme-leila Infetility Clinic, Nayband e Shomali, Bandar Abbas, Hormozgan, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7915753615
Phone
+98 76 3333 3821
Email
one.leila@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandar Abbas Islamic Azad University
Full name of responsible person
Alireza Saybani
Street address
Bandar Abbas Islamic Azad University,Daneshgah BLV, Golshahr
City
Bandar Abbas
Province
Hormozgan
Postal code
7915893144
Phone
+98 76 3367 0243
Fax
+98 76 3367 0243
Email
info@iauba.ac.ir
Web page address
http://iauba.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandar Abbas Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kobra Haji Alizadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Psychology, Islamic Azad University of Bandar Abbas, ِِDaneshgah BLV,Bandar Abbas,Iran