Evaluation the effect of intrauterine injection of recombinant human chorionic gonadotropin at different doses, before embryo transfer in improvement of implantation and pregnancy rates in in vitro fertilization/intracytoplasmic sperm injection: a prospective randomised controlled trial study.
Objective: Evaluation of intrauterine injection of recombinant human chorionic gonadotropin at different doses before embryo transfer in improvement of implantation and pregnancy rates in in vitro fertilization/intracytoplasmic sperm injection Design: parallel randomised controlled trial ,single blind Setting: The Mother & Child hospital, IVF-ET Center. Participants: Infertility patients younger than 40 years who referred for IVF-ICSI at the reproductive medicine center of The Mother & Child hospital. 420 patients fulfilled the study requirements. The inclusion criteria were female age under 40 years old with infertility. Exclusion criteria were previous IVF/ICSI trials, including a successful trial, endometriosis, azoospermia, uterine myoma or previous myomectomy, or the existence of hydrosalpinges. Sample size: 420 patients Intervention(s): The study groups (n = 105 in each group) received different doses ( 500 μg ,250 ,125 of rhCG intrauterine injection 12 minutes before ET. The control group (n = 105) underwent ET without rhCG. Intervention time: intrauterine injection of rhCG 12 minutes before ET. Main Outcome Measure(s): Clinical pregnancy rate (PR) and implantation rate (IR).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020921008N1
Registration date:2015-04-11, 1394/01/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-11, 1394/01/22
Registrant information
Name
Gooya Madadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3227 9715
Email address
gmadadi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of intrauterine injection of recombinant human chorionic gonadotropin at different doses, before embryo transfer in improvement of implantation and pregnancy rates in in vitro fertilization/intracytoplasmic sperm injection: a prospective randomised controlled trial study.
Public title
Evaluation of intrauterine injection of recombinant human chorionic gonadotropin at different doses in improvement of pregnancy rates in in vitro fertilization/intracytoplasmic sperm injection
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: female age under 40 years old with infertility. Exclusion criteria: previous IVF/ICSI trials, including a successful trial, endometriosis, azoospermia, uterine myoma or previous myomectomy, or the existence of hydrosalpinges.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
420
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Science Researching، Shiraz univercity of Medical Science
Street address
Shiraz University of Medical Science , Zand Street
City
Shiraz
Postal code
Approval date
2015-01-25, 1393/11/05
Ethics committee reference number
ct-p-9387-8237
Health conditions studied
1
Description of health condition studied
Female Infertility
ICD-10 code
N97
ICD-10 code description
Female Infertility
Primary outcomes
1
Description
implantation rate
Timepoint
two weeks after embryo transfer
Method of measurement
conventional pregnancy test
Secondary outcomes
1
Description
Clinical pregnancy rate
Timepoint
three weeks after a positive pregnancy test
Method of measurement
ultrasound
Intervention groups
1
Description
Intervention group: receiving rhCG as intrauterine injection 12 minutes before ET. .
Category
Treatment - Drugs
2
Description
Control group: undergoing ET without a previous intrauterine injection of rhCG.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mother & Child hospital
Full name of responsible person
dr Gooya Madadi
Street address
Shiraz University of Medical Sciences، Zand Street، Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Shiraz University of Medical Sciences، Zand Street، Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
dr Gooya Madadi
Position
Fellowship of Obstetrics & GYN, Infertility
Other areas of specialty/work
Street address
Shiraz university of medical science ، zand street
City
Shiraz
Postal code
Phone
+98 71 3227 9715
Fax
Email
gmadadi@sums.ac.irs.kharati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr afsoon zarei
Position
Obstetrics and Gynecologist / infertility fellowship
Other areas of specialty/work
Street address
Shiraz University of Medical Science , Zand Street
City
Shiraz
Postal code
Phone
+98 71 3227 9715
Fax
Email
zareia@sums.ac.irs.kharati@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
sara kharati
Position
researcher
Other areas of specialty/work
Street address
Shiraz University of Medical Science , Zand Street
City
Shiraz
Postal code
Phone
+98 71 3628 1591
Fax
Email
s.kharati@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)