Assessment of the effect of intrauterine injection of human chorionic gonadotropin (hCG) before embryo transfer on the implantation and pregnancy rates in the intracytoplasmic sperm injection (ICSI) method among patients who referred to Avicenna Infertility Clinic during 2013-2014.
(1) Objectives: Comparing implantation and pregnancy rates between the treatment and control groups
(2) Design: Double-blind randomized controlled trial
(3) Setting and Conduct: Participants are randomly assigned to the treatment and control groups. After the study intervention, the two groups are compared in terms of implantation and pregnancy rates. Data are gathered via a study form and are analysed using SPSS software..
(4) Participants: All ICSI candidates referring to Avicenna Infertility Clinic during 2013-14 aged between 20 and 40 yr with infertility due to male factor, PCO, or with unknown cause without previous successful or failed IVF/ICSI or any significant abnormality in the uterus and reproductive system.
(5) Intervention: Intrauterine injection of 500 units HCG dissolved in 40 microliter culture media in the treatment group and only 40 microliter culture media in the control group immediately before embryo transfer.
(6) Main outcome measures: Implantation rate and pregnancy rate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013060913605N1
Registration date:2013-08-18, 1392/05/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-18, 1392/05/27
Registrant information
Name
Bita Badehnoosh
Name of organization / entity
Avicenna Infertility Clinic
Country
Iran (Islamic Republic of)
Phone
+98 21 23519
Email address
b.badehnoosh@avicenna.ac.ir
Recruitment status
Recruitment complete
Funding source
Avicenna Infertility Clinic
Expected recruitment start date
2013-07-06, 1392/04/15
Expected recruitment end date
2014-03-17, 1392/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of intrauterine injection of human chorionic gonadotropin (hCG) before embryo transfer on the implantation and pregnancy rates in the intracytoplasmic sperm injection (ICSI) method among patients who referred to Avicenna Infertility Clinic during 2013-2014.
Public title
The effect of intrauterine injection of human chorionic gonadotropin (hCG) before embryo transfer on the implantation and pregnancy rates in the intracytoplasmic sperm injection (ICSI)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: age between 20 and 40 yr; infertility due to male factor, PCO, or with unknown cause; informed consent from couples; obtaining high quality embryos
Exclusion criteria: azoospermia or severe oligoasthenoteratospermia; previous successful or failed IVF/ICSI; myometrium or any uterus abnormality; previous myomectomy; moderate to severe endometriosis; hydrosalpynx; obtaining more than 20 ovums or probable OHSS; nonadherence to the study protocol
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
121
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Explanation regarding blinding of the study: It is evident that researcher is aware of the intervention but who performs the intervention is unaware and is not from research group. Moreover, according to informed consent, participants should be informed that may receive a certain drug but they are not aware of their group. All steps of the study are similar for both groups except that controls receive only culture media instead of hCG plus culture media in the treatment group; neither the patient nor the operator is aware of the content of the instillation. It seems there is no problem regarding the blindness of the study.
Secondary Ids
1
Registry name
No secondary ID
Secondary trial Id
No secondary ID
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Avicenna Infertility Clinic
Street address
No 97, Yakhchal - Shariati Junction, Shariati St.
City
Tehran
Postal code
19615-1177
Approval date
2013-06-25, 1392/04/04
Ethics committee reference number
92/1556
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
Z31.2
ICD-10 code description
In vitro fertilization
Primary outcomes
1
Description
Implantation rate
Timepoint
2 weeks after embryo transfere
Method of measurement
Serum level of B-hCG (mIU/ml) based on laboratory report
2
Description
Pregnancy rate
Timepoint
3 weeks after positive serum B-hCG
Method of measurement
Detection of gestational sac by ultrasonographic exam
Secondary outcomes
1
Description
Serum level of B-hCG
Timepoint
2 weeks after embryo transfere
Method of measurement
mIU/ml based on laboratory report
Intervention groups
1
Description
Intrauterine injection of hCG and embryo transfer in the treatment group: immediately before embryo transfer, 500 IU of hCG dissolved in 40 microliter culture media is instilled into the uterine cavity using an insemination catheter. After that, embryos are transferred into the uterine cavity.
Category
Treatment - Other
2
Description
Intrauterine injection of placebo and embryo transfer in the control group: immediately before embryo transfer only 40 microliter culture media is instilled into the uterine cavity using an insemination catheter. After that, embryos are transferred into the uterine cavity.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Avicenna Infertility Clinic
Full name of responsible person
Dr Bita Badehnoosh
Street address
No 97, Yakhchal - Shariati Junction, Shariati St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Avicenna Infertility Clinic
Full name of responsible person
Dr Mohammad Mahdi Akhondi
Street address
No. 97, Yakhchal-Shariati Junction, Shariati St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?