The effects of intrauterine injection of human chorionic gonadotropin ( HCG) before embryo transfer on fertility outcomes in infertile women undergoing Invitro fertilization (IVF).
The aim of the current study is to investigate the fertility outcomes of intrauterine injection of human chorionic gonadotropin (HCG) prior to embryo transfer in infertile women undergoing In vitro fertilization (IVF). All patients younger than 40 years old referred to the infertility clinic of Shariati hospital candidate for their first IVF cycle during 2012-2013, would be approached. Patients with endometriosis, azoospermia, uterine fibroids or history of myomectomy, and those with hydrosalpingitis will be excluded. A total of two hundred recruited patients, will be randomly allocated in intervention (n=100) and control group (n=100). After starting ''LONG'' protocol, ovum retrieval and 2-3 days after in vitro fertilization, patient will be ready for embryo transfer. In intervention group we introduce a soft catheter and inject 0.4 cc embryo culture media fluid with 0.1 cc (500 units) HCG of coracon type to the uterus (Ferring, Düsseldorf, Germany). Embryos will be transferred using another catheter after 7 minutes. In control group 500µl embryo culture media fluid would be injected to the uterus. Embryos will be transferred using another catheter after 7 minutes. In both groups speculum will be removed after 3 minutes. Fertility outcomes, including biochemical and clinical pregnancies, will be compared between two groups. The study is double blind. Both the patient and the performer of IVF procedure are not aware of the categorizations.
General information
Acronym
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IRCT registration information
IRCT registration number:IRCT201208058469N2
Registration date:2013-04-15, 1392/01/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-15, 1392/01/26
Registrant information
Name
Zahra Najmi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4426 3561
Email address
zahranaj@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences.
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2014-01-05, 1392/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of intrauterine injection of human chorionic gonadotropin ( HCG) before embryo transfer on fertility outcomes in infertile women undergoing Invitro fertilization (IVF).
Public title
Fertility outcomes following intrauterine injection of human chorionic gonadotropin (HCG) before embryo transfer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients younger than 40 years old referred to the infertility clinic of Shariati Hospital and will undergo In vitro fertilization (IVF) for the first time.
Exclusion criteria: Patients with endometriosis, azoospermia, patients with uterine fibroids or history of myomectomy, and patients with hydrosalpingitis
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
City
Tehran
Postal code
Approval date
2012-11-17, 1391/08/27
Ethics committee reference number
69702
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
inability to achieve a pregnancy sterility, female NOS
Primary outcomes
1
Description
Pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
detection of fetal heart rate in trans vaginal sonography
Secondary outcomes
1
Description
Implantation rate
Timepoint
3 weeks after embryo transfer
Method of measurement
number of gestational sacs in trans vaginal sonography to the number of embryos transferred in each cycle
2
Description
ongoing pregnancy
Timepoint
continuation of pregnancy in 20 weeks
Method of measurement
sonography
3
Description
Abortion
Timepoint
before 20 weeks
Method of measurement
sonography
4
Description
multiple pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
more than one sac containing fetal heart in sonography
5
Description
ectopic pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
sonography
Intervention groups
1
Description
Intrauterine injection of 0.1 cc (500 units) of human chorionic gonadotropin (HCG) (Coracon type, Ferring, Düsseldorf, Germany) before embryo transfer