The evaluation of intrauterine HCG injection in oocyte retrieval day, in Assisted Reproductive Technique(ART) outcome
Design
Two arm parallel group randomised controlled clinical trial without blinded, with sample size 112
Settings and conduct
Infertile patients referring to Afzalipour Hospital infertility who enter the IVF / ICSI cycle, in intervention group, after oocyte retrieval, the speculum is placed and HCG is injected into the uterus with a catheter of IUI. In the control group, the substance is not injected into the uterus.
The oocytes of the two groups are fertilized with IVF / ICSI and embryos transfered three days after oocyte retrieval .
Chemical pregnancy is measured by measuring BHCG two weeks after embryo transfer and clinical pregnancy by ultrasound and observing the fetal heart rate 2-3 weeks after the positive pregnancy test.
Participants/Inclusion and exclusion criteria
Infertile women who are referred to the Afzalipour Infertility Center in Kerman and have inclusion criteriaare enrolled in the study.
Inclusion criteria: Age less than 40 years
Exclusion criteria: Age older than 40 years, azospermia, uterine leiomyoma with endometrial pressure, endometriosis, Recurrent implantation failure: failure to achieve a clinical pregnancy after transfer of at least three good-quality embryos, Endocrine disease, Hydrosalpinx
Intervention groups
In the intervention group, the hCG ampoule is injected into the uterine cavity on retrieval day.
In the control group, no drug is injected into the uterine cavity.
Main outcome variables
Implantation rate; Chemical pregnancy rate; Clinical pregnancy rate; Abortion rate;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151004024335N3
Registration date:2018-07-07, 1397/04/16
Registration timing:prospective
Last update:2018-07-07, 1397/04/16
Update count:0
Registration date
2018-07-07, 1397/04/16
Registrant information
Name
robabe hoseinisadat
Name of organization / entity
infertility institute center of shahid sadughi
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 7085
Email address
robabehoseini@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of intrauterine HCG injection in oocyte retrieval day, in Assisted Reproductive Technique(ART) outcome
Public title
intrauterine HCG in infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertility
Age less than 40 years
Female
Exclusion criteria:
Age older than 40 years
azospermia
uterine leiomyoma with endometrial pressure
endometriosis
Recurrent implantation failure: failure to achieve a clinical pregnancy after transfer of at least three good-quality embryos
Endocrine disease
Hydrosalpinx
Age
To 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
simple ,individual, table of random numbers randomization
Blinding (investigator's opinion)
Not 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 Kerman University of Medical Sciences
Street address
Ibn Sina Street, Jihad Boulevard, Somayeh Road (Tahmasebabad)
City
kerman
Province
Kerman
Postal code
7619813159
Approval date
2018-06-26, 1397/04/05
Ethics committee reference number
IR.KMU.REC.1397.070
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
Measurement of serum beta-HCG
Secondary outcomes
1
Description
Abortion rate
Timepoint
Before the 20th week of pregnancy
Method of measurement
Contact patients at the 20th week of pregnancy
2
Description
Implantation rate (the number of gestational sacs divided by the number of transferred embryos)
Timepoint
Five weeks after embryo transfer
Method of measurement
Transvaginal ultrasound
3
Description
Clinical pregnancy
Timepoint
Five weeks after embryo transfer
Method of measurement
Transvaginal ultrasound
Intervention groups
1
Description
In the intervention group, infertile patients in IVF or microinjection cycle receive routine treatment until the day of oocyte retrieval. On oocyte retrieval day that performed with general anesthesia, after oocyte puncture, 1000 units of Pooyesh Darou PDP PREG HCG, with a volume of one cc, injected into the uterine cavity, with Intrauterine insemination Catheter.
Category
Treatment - Drugs
2
Description
In the control group, the drug administration, oocyte retrieval and embryo transfer are performed routinely and no additional drug is injected into the uterus.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Infertility Center
Full name of responsible person
Dr Robabe Hosseinisadat
Street address
Imam Khomeini Highway, Afzalipour Hospital
City
kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8486
Email
robabehosseinisadat@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Research Assistant, Kerman University of Medical Sciences
Street address
Ibn Sina Street, Jihad Boulevard, Somayeh Road (Tahmasebabad)
City
kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
robabehosseinisadat@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
robabehosseinisadat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Highway, Afzalipour Hospital
City
kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8486
Fax
Email
robabehosseinisadat@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
robabe hosseinisadat
Position
Assistant Professor Assistant Definitions of assistant noun a person who ranks below a senior person
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Highway, Afzalipour Hospital
City
kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8486
Fax
Email
robabehosseinisadat@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
robabe hosseinisadat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Highway, Afzalipour Hospital
City
kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8486
Fax
Email
robabehosseinisadat@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The final result of the study will be published and there is no need to share individual participants' data.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available