This study is a parallel randomized clinical trail among infertile patients under 40 years old who refereed to research and clinical center for infertility in yazd and candidate for IVF/ICSI. Controlled ovarian hyper-stimulation done with antagonist protocol. First sonography for follicular growth assessment done in 7th days of stimulation and then patients monitored every 1-2 days with sonography till at least three follicles with average diameter of 18 mm present. Then estradiol and progesterone level measured. Patients with progesterone blood level equal or below 1ng/ml entered in study. Patients divide in two groups with Table of random numbers. Final oocyte maturation with 5000-10000 IU,HCG done at the same day in first group (early trigger group) and 24 hours later in second group (late trigger group). Then oocyte puncture done. We will classify the oocytes maturation based on the morphological appearance. All of retrieved oocytes undergo IVF / ICSI. A maximum of two embryos transfer on day 2 or 3 after oocytes extract. Vaginal progesterone for luteal phase support, start from the day of puncture. Pregnancy test perform Two weeks after the transfer. The main variable is the number of oocytes in metaphase וו. Other variables are , the number of fertilized oocytes (2PN) and the number of embryos formed and chemical and clinical pregnancy rate in each groups. These variables are then compare in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071628756N3
Registration date:2016-09-04, 1395/06/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Elham Naghshineh
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 7085
Email address
naghshineh@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid sadoughi university of medical sciences,research and clinical center for infertility
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Delaying the oocyte maturation trigger on numbers of metaphase װ oocytes based on blood progesterone level
Public title
Effect of Delaying the oocyte maturation trigger on numbers of mature oocytes
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:infertile patients under 40 years old who refereed to research and clinical center for infertility in yazd for IVF/ICSI
exclusion criteria: age over 40 years
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:
40
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
shahid sadougi university of medical sciences
Street address
yazd
City
yazd
Postal code
Approval date
2016-06-12, 1395/03/23
Ethics committee reference number
17/1/80248/پ
Health conditions studied
1
Description of health condition studied
female infertility
ICD-10 code
N97.9
ICD-10 code description
female infertility-unspecifide
Primary outcomes
1
Description
number of metaphase II oocytes
Timepoint
after intervention
Method of measurement
number
2
Description
number of fertilized oocytes (2PN)
Timepoint
after intervention
Method of measurement
number
3
Description
number of embryo formation
Timepoint
after intervention
Method of measurement
number
Secondary outcomes
1
Description
chemical pregnancy
Timepoint
14 days after transfer
Method of measurement
BHCG test
2
Description
clinical pregnancy
Timepoint
28 days after transfer
Method of measurement
transvaginal sonography
Intervention groups
1
Description
in the intervention group patients receive HCG to trigger final oocytes with 24-hour delay
Category
Treatment - Drugs
2
Description
In the control group receive HCG for routine final oocyte maturation on the same day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
research and clinical center of infertility
Full name of responsible person
robab darar
Street address
boo ali/saffaieh
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
research and clinical center for infrtility
Full name of responsible person
alimohammadabdoli
Street address
safaieh,booali
City
yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research and clinical center for infrtility
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
research and clinical center for infrtility
Full name of responsible person
Elham Naghshineh
Position
fellowship
Other areas of specialty/work
Street address
safaieh,booali
City
yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
Naghshineh@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
shahid sadoughi university of medical science
Full name of responsible person
Robab Davar
Position
assistant proffesor
Other areas of specialty/work
Street address
safaieh,booali
City
yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
davr@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
research and clinical center for infrtility
Full name of responsible person
Elham Naghshineh
Position
fellowship
Other areas of specialty/work
Street address
safaieh,booali
City
yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
Naghshineh@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)