Determining the effect of simultanious administration of FSH and hCG for triggering on oocyte quality and ART outcome in antagonist protocol
Design
A Randomized, single-blinded, controlled clinical trial with a parallel-group design of 110 patients. The randomization list was generated by using the "www.sealedenvelope.com" site.
Settings and conduct
Location: Infertility ward of Arash Women's Hospital
Method: The patients enter the antagonist cycle and after frequent follicular monitoring and defining the triggering time, informed consent is obtained and the patient is randomized into two groups HCG 10000+FSH450I.U. or HCG 10000; both groups undergo oocyte pickup 34-36 hours after triggering. the oocytes will be denuded and evaluated by the embryologist, then IVF/ICSI is done and after 2 or 3-day embryos, if present will be transferred.
Blinding: Single Blinded
Participants/Inclusion and exclusion criteria
Inclusion: age between 18-38; FSH below10 and AFC more than 5; normal uterine cavity; antagonist protocol IVF cycles
Non Inclusion: Estradiol than 4500; Cancellation of oocyte retrieval; History of more than 2 failed IVF/ICSI; Severe male factor
Intervention groups
Intervention group: injection of 450 units of FSH plus1000 units of HCG
Control group: injection of only 1000 units of HCG
Main outcome variables
Oocyte quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150310021420N5
Registration date:2021-06-14, 1400/03/24
Registration timing:registered_while_recruiting
Last update:2021-06-14, 1400/03/24
Update count:0
Registration date
2021-06-14, 1400/03/24
Registrant information
Name
Maryam Farid Mojtahedi
Name of organization / entity
Arash women hospital,clinic for infertility,Tehran university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 8755
Email address
m_fmojtahedi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical sciences
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of simultanious administration of FSH and hCG for triggering on oocyte quality and ART outcome in antagonist protocol
Public title
FSH administration for triggering final oocyte maturation in improving ART outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18 and 38
third day FSH below10IU/ml and AFC more than 5 in each ovary
normal uterine cavity
antagonist protocol IVF cycles
Exclusion criteria:
Estradiol at day of trigger more than 4500IU/l
Cancellation of oocyte retrieval due to cycle cancellation or changing to IUI
History of more than 2 failed IVF/ICSI
Severe male factor
Age
From 18 years old to 38 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
According to Stratified Block randomization, the samples will be divided into two groups of intervention and control. The number of blocks will be 6. The mentioned list will be generated by using the "www.sealedenvelope.com" site. The random allocation list is solely available to the epidemiologist. For the Concealment of the random allocation process, treatments will be written on 110 cards, respectively. then the cards are placed inside sealed envelopes. When the physician announces the eligibility of a patient, the methodologist will provide the physician with the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor of the final outcome (oocyte quality), who is the embryologist, is unaware of the type of cycle regimen. The data analyzer is also unaware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of School of Medicine - Tehran University of Medical Sciences
Street address
Poorsina st - Qods st - enghelab st - Tehran-Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-02-01, 1395/11/13
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.1601
Health conditions studied
1
Description of health condition studied
femaleInfertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Oocyte quality
Timepoint
Day of ovarian puncture
Method of measurement
gardner scale by microscope
Secondary outcomes
1
Description
clinical pregnancy
Timepoint
28 days after transfer
Method of measurement
vaginal ultrasound and observation of fetal heart beat
2
Description
ongoing pregnancy
Timepoint
after first trimester
Method of measurement
sonography and observation of alive fetus
Intervention groups
1
Description
Intervention group: The patients enter antagonist cycle and after frequent follicular monitoring and defining the triggering time . When at least two oocytes were seen HCG 10000+FSH450I.U were injected.
Category
Treatment - Drugs
2
Description
Control Group: The patients enter antagonist cycle and after frequent follicular monitoring and defining the triggering time . When atleast two oocytes were seen, HCG 10000 was injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash women's hospital
Full name of responsible person
Maryam Farid Mojtahedi
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Email
m_fmojtahedi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Qods St, Keshavarz Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?