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Comparison of patients with poor ovarian response included in the antagonist cycle during standard, dual and triple triggering in IVF outcomes

Protocol summary

Study aim
To compare IVF results in patients with poor ovarian response included in the antagonist cycle recieving standard, double, and triple ovarian stimulation
Design
Three-arm parallel-group randomized clinical trial with 108 patients allocated into three groups, enrolled between April 2023- October 2023.
Settings and conduct
POR patients referred to the infertility department of Al-Zahra Educational Hospital, Tabriz, are assessed for eligibility to participate in the study. The eligible patients undergo controlled ovarian stimulation using antagonist protocol. After the diameter of the follicles reaches 16-18 mm, the randomization of patients into the study groups will be conducted by a nurse, using sealed envelopes, each containing a study group. Staff and patients will not be blinded. After 34- 36 hours, oocytes will be retrieved and evaluated by an embryologist. Following fertilization of the eggs and assessing embryo quality, embryo transfer will be performed and patients will undergo a pregnancy test (after two weeks) and vaginal ultrasound (after six weeks).
Participants/Inclusion and exclusion criteria
Inclusion criteria: informed consent to participate in the experiment, the eligibility of patients for IVF, the presence of POR, age between 24-42 years old, BMI of 19-27, and male partner having normal sperm evaluations (WHO criteria). Exclusion criteria: The presence of uterine anomalies, severe male factor infertility, severe endometriosis, drug allergy, and medical conditions such as hypothyroidism and diabetes.
Intervention groups
POR patients are randomly divided into three groups: Group A, receiving human chorionic gonadotropin (hCG) (standard triggering), Group B, receiving hCG and decapeptide (as GnRHa) (dual triggering), and Group C, receiving hCG, Decapeptyl, and menotropin (hMG) (triple triggering).
Main outcome variables
Primary outcome: The number of high-quality embryos

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230702058644N1
Registration date: 2023-08-12, 1402/05/21
Registration timing: registered_while_recruiting

Last update: 2023-08-12, 1402/05/21
Update count: 0
Registration date
2023-08-12, 1402/05/21
Registrant information
Name
Aliyeh Ghasemzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3177 1041
Email address
alghasemzadeh@yahoo.co.uk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-11, 1402/04/20
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of patients with poor ovarian response included in the antagonist cycle during standard, dual and triple triggering in IVF outcomes
Public title
Comparison of patients with poor ovarian response included in the antagonist cycle during standard, dual and triple triggering in IVF outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
informed consent to participate in the study Age between 24-42 years old Body mass index of 19-27 The presence of POR (AFCI <7, AMH <1.5) Eligibility of the patient for IVF The absence of uterine abnormalities
Exclusion criteria:
Hypothalamic dysfunctions in the patient diabetes mellitus liver diseases heart diseases renal diseases epilepsy metabolic disorders
Age
From 24 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be allocated to each study group by the balanced block randomization technique. The number of blocks and the size of each block are 36 and 3, respectively (َA, B, and C). The order of study groups in each block will determine the order of allocations.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Comparison of patients with poor ovarian response included in the antagonist cycle during standard, dual and triple triggering in IVF outcomes

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Women's Reproductive Health Research Center, A lzahra Educational Hospital, Baghshomal square, South Artesh street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Approval date
2023-07-11, 1402/04/20
Ethics committee reference number
IR.TBZMED.REC.1402.287

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
infertilefertility

Primary outcomes

1

Description
The number of good quality embryos
Timepoint
3 days after fertilization
Method of measurement
High-quality cleavage stage embryos will have six cells or greater on day 3 and less than 10% fragmentation and symmetric blastomeres, according to the Istanbul consensus workshop.

Secondary outcomes

1

Description
number of retrieved oocytes
Timepoint
36 hours after triggering
Method of measurement
All oocyte retrievals will be performed under transvaginal ultrasound guidance and will be counted using light microscopy.

2

Description
the number of mature oocytes
Timepoint
36 hours after triggering
Method of measurement
All oocyte retrievals will be performed under transvaginal ultrasound guidance and the number of mature oocytes will be counted using light microscopy.

3

Description
the number of clinical pregnancies
Timepoint
the presence of gestation sac two weeks after a positive hCG blood test
Method of measurement
ultrasound scan

4

Description
implantation rate
Timepoint
at 6–7 weeks of pregnancy
Method of measurement
Implantation rate is calculated from the number of gestational sacs with a visible fetal heart on ultrasound scan divided by the total number of transferred embryos.

Intervention groups

1

Description
Control group: Standard triggering via the injection of human gonadotropic hormone (hCG)
Category
Treatment - Drugs

2

Description
Intervention group 1: dual triggering via hCG and Decapeptyl
Category
Treatment - Drugs

3

Description
Intervention group 2: triple triggering via administration of hCG, Decapeptyl, and menotropin
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Educational Hospital
Full name of responsible person
Dr. Aliyeh Ghasemzadeh
Street address
Alzahra Hospital, Artesh Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
gasemzadeha@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Aliyeh Ghasemzadeh
Street address
Alzahra Hospital, Artesh Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
gasemzadeha@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Aliyeh Ghasemzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3177 1041
Fax
Email
alghasemzadeh@yahoo.co.uk

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Aliyeh Ghasemzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3177 1041
Fax
Email
alghasemzadeh@yahoo.co.uk

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Aliyeh Ghasemzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3177 1041
Fax
Email
alghasemzadeh@yahoo.co.uk

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
all collected deidentified IPD
When the data will become available and for how long
Our data can be potentially available on October 2023.
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
None
From where data/document is obtainable
email address: zohrehmohammadi98@gmail.com
What processes are involved for a request to access data/document
Sending an email to the mentioned address and sending an identity proof that reveals the hiring academic institute is sufficient for us to share the data.
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