The main objective of this study is injection of follicular fluid into uterine cavity on implantation rate in IVF cycle. In a randomized unit-central clinical trial, 68 patients with recurrent implantation failure referring to infertility clinic of Alzahra Hospital, Tabriz, Iran, will be randomly assigned to two groups’ case and control. The main inclusion criterion are: FSH levels below mIU / m l 10 and age between 20 to 40 years and the main exclusion criterion are have history of two or more implantation failure in in-vitro fertilization and having endometriosis. Patients were randomly placed in two groups of 55 people. From day 2 or 3 cycles 150 to 300 IU FSH injection and ovulation induction will start. After 6 or 7 cycles, antagonist of GnRH injections administered at a dose of 250 mg daily and 75 to 150 units monogon will be added to the diet 1 to 2 Tablets. After see at least three follicles larger than 18 mm HCG will be injected and then 34 to 36 hours after that, will be done the puncture of ovarian follicles.
The follicular fluid of 2 or 3 follicular puncture obtained If that is not tinged with blood, after removal of the oocyte will be centrifuge and collected in a separate tube. After punctureو2 ml of the liquid will be injected into the uterus using catheters IUI. In this study, the primary outcome of successful implantation and clinical pregnancy is considered to be a secondary consequence. In the control group method is the same of case without injected follicular liquid.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021713566N3
Registration date:2015-05-29, 1394/03/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-29, 1394/03/08
Registrant information
Name
Kobra Hamdi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1554 1221
Email address
hamdik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-04-19, 1394/01/30
Expected recruitment end date
2016-07-20, 1395/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of injection of follicular fluid into uterine cavity on implantation rate in IVF cycle
Public title
Study of injection of follicular fluid into uterine cavity on implantation rate in IVF cycle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 20 to 40 years old; FSH levels below mIU / m l 10; BMI less than 35 kg /m2; transfer 2 or 3 embryos Grade A or B;
Exclusion criteria: patients with endometriosis; hydrosalpinx; uterine anatomical abnormalities such as myoma; polyps; mullerian anomalies like two horns of the uterus; endocrine disorders such as thyroid disease; PCO and have a history of two or more implantation failure.
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:
110
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tabriz University of Medical Sciences
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Approval date
2015-05-16, 1394/02/26
Ethics committee reference number
TBZMED.REC.1394.129
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Chemical Pregnancy
Timepoint
Measure B-HCG Sixteen days after injection of HCG
Method of measurement
ΒhCG test
2
Description
Clinical pregnancy ( gestational sac seen by viewing the fetal heart rate and fetal pole
Timepoint
After positive βhCG
Method of measurement
Ultrasound
3
Description
Implantation rates
Timepoint
Two weeks after a positive pregnancy test
Method of measurement
Ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
In the control group: Antagonist protocol GnRH will be used to stimulate ovulation, HCG may be used to seeing at least three follicles larger than 18 mm. After 34 to 36 hours will puncture of ovarian follicles
Category
Treatment - Drugs
2
Description
In the intervention group: Antagonist protocol GnRH will be used to stimulate ovulation, HCG may be used to seeing at least three follicles larger than 18 mm. After 34 to 36 hours will puncture of ovarian follicles. After isolation of the oocyte Part of follicular fluid from the puncture. Will be injected by intrauterine 2 cc of liquid by using IUI catheter after follicle puncture embryo transfer will take place two days after ovarian puncture.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr. Kobra Hamdi
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Kobra Hamdi
Position
Associate professor
Other areas of specialty/work
Street address
Golgasht Street, Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3556 9543
Fax
Email
hamdik@tbzmed.ac.ir; lahroudin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Kobra Hamdi
Position
Associate professor
Other areas of specialty/work
Street address
Golgasht Street, Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3556 9543
Fax
Email
hamdik@tbzmed.ac.ir; lahroudin@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Kobra Hamdi
Position
Associate professor
Other areas of specialty/work
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
hamdik@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)