Evaluation of IVF Outcomes in Patients with Decreased Ovarian reserve with Double Stimulation during Follicular and Luteal Phase Compared with conventional Antagonist Cycle
Evaluation of IVF Outcomes in Patients with Decreased Ovarian reserve with Double Stimulation during Follicular and Luteal Phase Compared with conventional Antagonist Cycle
Design
Two arm parallel group randomised, single blinded clinical trial with 54 patients. For randomization, permutation block stratified randomization method was used.
Settings and conduct
This randomized study will be performed on 54 women IVF candidates in the infertility center of Ali Ibn Abitaleb Hospital in Zahedan. patients will be divided into the two intervention groups. The data collection tool is through a data collection checklist. In this single-blindedclinical trial without control group, randomization will be performed by permutation block method.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with reduced ovarian reserve who are candidates for IVF.
Endometriosis less than grade 3.
No contraindications to use of ovarian stimulation medications.
At the same time, the patient's partner should not have azoospermia.
Total oocyte recovery rate
The mean Metaphase II (MII) oocyte counts
The number of fetus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120817010617N8
Registration date:2021-07-21, 1400/04/30
Registration timing:registered_while_recruiting
Last update:2021-07-21, 1400/04/30
Update count:0
Registration date
2021-07-21, 1400/04/30
Registrant information
Name
morteza Sedaghat Kia
Name of organization / entity
zaums
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 9540
Email address
morimedico@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-11, 1400/04/20
Expected recruitment end date
2022-01-10, 1400/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of IVF Outcomes in Patients with Decreased Ovarian reserve with Double Stimulation during Follicular and Luteal Phase Compared with conventional Antagonist Cycle
Public title
Evaluation of IVF Outcomes in Patients with Decreased Ovarian reserve with Double Stimulation Compared with conventional Antagonist Cycle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with reduced ovarian reserve who are candidates for IVF.
Endometriosis less than grade 3.
No contraindications to use of ovarian stimulation medications.
At the same time, the patient's partner should not have azoospermia.
Exclusion criteria:
Age
To 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Care provider
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of patients to two groups will be done by permutation block stratified randomization method. Eligible patients will be classified according to age and BMI, respectively. Then, based on 4 blocks (consisting of two groups A and B and two repetitions for each) patients will be randomly selected from all possible modes of permutations, and will be assigned to the desired group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this clinical trial, the Single-Blinding method will be used. So that the technician responsible for recording of the consequences will not be aware of the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr.Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2021-01-10, 1399/10/21
Ethics committee reference number
IR.ZAUMS.REC.1399.447
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Total oocyte recovery rate
Timepoint
After oocyte retrieval
Method of measurement
Via Ultrasound Sonography
2
Description
The mean Metaphase II (MII) oocyte counts
Timepoint
Oocyte pick up day
Method of measurement
Microscopic assay
3
Description
The number of fetus
Timepoint
After puncture
Method of measurement
Microscopic assay -The number of fetuses after injection.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Double Stimulation, Patient's receipt HMG and FSH from day 2 and then when the follicle is upper 13-millimeter cetrotide is consumed and when the follicle is upper 18 mliletr HCG is injected and after 36 hours puncture of the follicles is done. From the day after the puncture, patients receive one steroid antagonist daily for 4 days to lower hormone levels.
Category
Treatment - Drugs
2
Description
Intervention group: conventional Antagonist Cycle, Patients reciept cetrotide for three days that started from day 2 and after that HMG and FSH is started and then when the follicle is upper 13-millimeter cetrotide is consumed and when the follicle is upper 18 mliletr HCG is injected and after 36 hours puncture of the follicles is done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-ebn Abi Taleb Hospital, Zahedan
Full name of responsible person
Fateme Qahqaei
Street address
Ali-ebn Abi Talib Hospital, Salamat boulevard, Dr.Hesabi square ,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
morimedico@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Nour Mohammad Bakhshani
Street address
Dr Hesabi square
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
zaums.research@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Qahqaei
Position
Obstetrics & Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ali-ebn Abi Talib Hospital, Salamat Blvd, Dr.Hesabi Sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
morimedico@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Qahqaei
Position
Obstetrics & Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ali-ebn Abi Talib Hospital, Salamat Blvd, Dr.Hesabi Sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
morimedico@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Qahqaei
Position
Obstetrics & Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ali-ebn Abi Talib Hospital, Salamat Blvd, Dr.Hesabi Sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
morimedico@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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