Protocol summary

Summary
Acupuncture as a traditional method has beneficial effects on physiological systems, anxiety reduction, and quality of life enhancement. However, scientific rationales for this approach within in vitro fertilization and intracytoplasmic sperm injection (IVF/ICSI) have not been absolutely accepted. The aim of this study was to investigate the effects of acupuncture on IVF/ICSI outcome in women with polycystic ovarian (PCO) and comparing it with placebo acupuncture. Patients who had uncontrolled systemic disorders, ovum or embryo donor, other infertility factors exception PCO, and who for personal reasons did not want to participate further were excluded from the study. In thes triple blind study sixty-two women with PCO admitted to the clinic for treatment of infertility were randomly invited to participate (31 women were randomly set into the acupunctured group and 31 women were set into the control placebo group) between June 2009 to September 2010 . Acupuncture was performed in 5 sessional of thirthy minutes. Accordingly, in accupunctured group, traditional chinese medicine and in the placebo group based on wrong location the same needles were used.The results were followed 2, 4, and 18 weeks after embryo transfer, and postpartum (miscarriagem, Take home baby, Oocyte metaphase II rate, fertilization and embryo quality ).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201011275181N4
Registration date: 2011-04-13, 1390/01/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-04-13, 1390/01/24
Registrant information
Name
Batool Rashidi
Name of organization / entity
Vali E Asr Reproductive Health Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9320
Email address
bhrashidi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shayamehr clinic in Tehran
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2010-09-22, 1389/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of acupuncture on outcome of in vitro fertilization and intracytoplasmic sperm injection (IVF/ICSI) in women with polycystic ovarian
Public title
Effects of acupuncture on outcome of in vitro fertilization and intracytoplasmic sperm injection (IVF/ICSI) in women with polycystic ovarian
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with the diagnosis of PCO (Rotterdam criteria) admitted to the clinic for IVF or ICSI treatments of infertility . Exclusion criteria: Patients who had uncontrolled systemic disorders, ovum or embryo donor, other infertility factors exception PCO, and who for personal reasons did not want to participate further were excluded from the study.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical faculty, Tehran University of Medical Sciences
Street address
Tehran Medical Faculty, Poorsina St, Keshavarz Blvrd
City
Tehran
Postal code
Approval date
2009-07-07, 1388/04/16
Ethics committee reference number
397

Health conditions studied

1

Description of health condition studied
Female Infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation

Primary outcomes

1

Description
Oocyte Methaphase 2
Timepoint
before and after embryo transfer
Method of measurement
diagnosed by Embryologist and with embryological criteria

2

Description
Embryo quality
Timepoint
2 days after embryo transfer
Method of measurement
diagnosed by Embryologist and with embryological criteria

3

Description
Oocyte Fertilization rate
Timepoint
first day after embryo transfer
Method of measurement
diagnosed by Embryologist and with embryological criteria

Secondary outcomes

1

Description
Take home baby
Timepoint
9 months after Embryo transfer
Method of measurement
Delivery

2

Description
Biochemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
B-hcg

3

Description
Clinical pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
sac observed in vaginal Sonography

4

Description
Miscarriage
Timepoint
<12 weeks after embryo transfer
Method of measurement
vaginal sonography

Intervention groups

1

Description
Intervention group : Accuponcture based on Traditional Chinese Medicine, 5 sessins of thirthy minutes.
Category
Treatment - Other

2

Description
Control group: (Placebo ) the same needles are used in 5 sessions of thirthy minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shaya Mehr Clinic
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Medical Faculty, Tehran University of Medical Sciences
Full name of responsible person
Maryam Khorami
Street address
Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Faculty, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Vali-e-asr Reproductive Health Research Center
Full name of responsible person
Rashidi Batool
Position
Associate Proffesor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Valieasr Hospital and Imam khomeini Hospital
City
Tehran
Postal code
Phone
+98 21 6693 9320
Fax
Email
bhrashidi@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Vali-e-asr Reproductive Health Research Center
Full name of responsible person
Haghollahi Fedyeh
Position
Msc
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
Fax
Email
fedyeh_hagh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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