To determine whether intercourse during peritransfer period will improve pregnancy and implantation rates in patients undergoing In Vitro Fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI) . Materials & Methods: A Randomized Controlled Trial will be conducted to compare embryo transfer with intercourse 12h later ( n=195) and without intercourse up to 24h (n=195). Patients with history of at least 5 years infertility undergoing In Vitro Fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI) will be recruited. In this study implantation rate, chemical and clinical pregnancy rate will be compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706101132N2
Registration date:2008-12-25, 1387/10/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2008-12-25, 1387/10/05
Registrant information
Name
Abbas Aflatoonian
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
aflatoonian@yazdivf.org
Recruitment status
Recruitment complete
Funding source
The Research Deputy of Yazd University of Medical Sciences
Expected recruitment start date
2006-07-01, 1385/04/10
Expected recruitment end date
2006-12-01, 1385/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intercourse around embryo transfer on pregnancy rate in Assisted Reproductive Technology (ART) cycles
Public title
The effect of intercourse around embryo transfer on pregnancy rate in Assisted Reproductive Technology (ART) cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with history of at least 5 years infertility undergoing In Vitro Fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI)
Age
From 21 years old to 37 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
390
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics committee of Research and Clinical center for Infertility, Yazd University of Medical sci
Street address
Bouali Ave, Safaeyeh
City
Yazd
Postal code
8916877391
Approval date
empty
Ethics committee reference number
1582
Health conditions studied
1
Description of health condition studied
The factors which improved pregnancy rate in Assisted Reproductive Technology (ART) cycles
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Clinical Pregnancy
Timepoint
2 weeks
Method of measurement
ٍEmbryonic cardiac activity observed by ultrasound
2
Description
Implantation rate
Timepoint
2 weeks
Method of measurement
Number of gestational sacs per embryo transferred
3
Description
Chemical pregnancy
Timepoint
2 weeks
Method of measurement
Serum beta HCG
Secondary outcomes
empty
Intervention groups
1
Description
In study group the patients recommended to have intercourse 12h after embryo transfer
Category
empty
2
Description
In control group the patients recommended to abstain from intercourse up to 24 hours after embryo transfer
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical center for Infertility, Yazd Shahid Sadoughi university of Medical Sciences
Full name of responsible person
Abbas Aflatoonian
Street address
Bouali Ave, Safaeyeh
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Clinical center for Infertility, Yazd Shahid Sadoughi university of Medical Sciences
Full name of responsible person
Abbas Aflatoonian
Street address
Bouali Ave, Safaeyeh
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Clinical center for Infertility, Yazd Shahid Sadoughi 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
Name of organization / entity
Research and Clinical center for Infertility
Full name of responsible person
Abbas Aflatoonian
Position
Head/Professor
Other areas of specialty/work
Street address
Bouali Ave, Safaeyeh
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
abbas_aflatoonian@yahoo.com
Web page address
www.yazdivf.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research and Clinical center for Infertility
Full name of responsible person
Abbas Aflatoonian
Position
Head/Professor
Other areas of specialty/work
Street address
Bouali Ave, Safaeyeh
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
abbas_aflatoonian@yahoo.com
Web page address
www.yazdivf.org
Person responsible for updating data
Contact
Name of organization / entity
Research and Clinical center for Infertility
Full name of responsible person
Nasim Tabibnejad
Position
Research Consultant/ physician
Other areas of specialty/work
Street address
Bouali Ave, Safaeyeh
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
nasimtabib@yahoo.com
Web page address
www.yazdivf.org
Sharing plan
Deidentified Individual Participant Data Set (IPD)