Comparative study of Gonadotropin-releasing hormone (GnRH) agonist and antagonist protocol on IVF outcomes in endometriosis patients
Design
Patients are recruited in two parallel groups. allocation is done with block randomization for groups. participants and physicians are not blinded
Settings and conduct
Patients who refer to Taleghani Hospital's Infertility Center due to infertility and endometriosis are first checked. Then the study method is explained to them. Patients and doctors were not blinded to the type of treatment.
Participants/Inclusion and exclusion criteria
Patients aged between 20-40 years, patients with endometriosis without previous history of endometriosis surgery, patients with anti-mullerian hormone (AMH) level>1 ng/ml, Antral follicle count (AFC) number>5, patients with Ca125<200, and no untreated endocrine disease were included in the study.
exclusion criteria: Patients with structural problems of the uterus such as polyps or fibroids, patients with genetic disorders, and patients with a history of poor response to stimulation in previous cycles and a history of Ovarian hyperstimulation syndrome (OHSS)
Intervention groups
In the agonist protocol, the GnRH agonist starts from the previous mid-luteal cycle (on a daily basis), and from the second day of menses, gonadotropin is started for the patient and we follow and the trigger should be HCG.
In the antagonist protocol, the cycle is started on the second day of menses in endometriosis patients and based on the number of AFC and serum AMH levels as well as the age of the patient and the answers obtained in the previous cycles, if necessary, the treatment is started with gonadotropin and followed by ultrasound. It is done with an HCG trigger.
Main outcome variables
The quality and number of oocytes and embryos
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230403057803N1
Registration date:2023-04-24, 1402/02/04
Registration timing:prospective
Last update:2023-04-24, 1402/02/04
Update count:0
Registration date
2023-04-24, 1402/02/04
Registrant information
Name
mitra nemati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2560
Email address
mithraa.nemati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-08-06, 1402/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Gonadotropin-releasing hormone (GnRH) agonist vs GnRH antagonist in stimulation protocol on ART outcomes in infertile endometriosis patients
Public title
GNRH agonist vs GNRH antagonist in infertility treatment.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 20 and 40 years
Patients with endometriosis without a history of endometriosis surgery
Patients with anti-mullerian hormone (AMH) level > 1ng/ml
Number of antral follicle count (AFC)>5
Patients with Ca125<200
Absence of untreated endocrine disease
Exclusion criteria:
Patients with uterine structural problems such as polyps or fibroids
Patients with genetic disorders
Patients with a history of poor response to stimulation in previous cycles
History of ovarian hyperstimulation syndrome (OHSS)
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization in which patients are randomly divided into two groups of 60 patients using a table of random numbers. An independent researcher makes random allocation cards using computer-generated random numbers. He keeps the original random allocation sequences in an inaccessible third place and works with a copy. Since the executors can get confused with the original coding of A and B later, the allocator should record exactly what these codes mean to avoid further confusion. Next, we print it out and put each of the sheets one by one into each envelope. The allocation sequence was concealed from the researcher (JR) enrolling and assessing participants in sequentially numbered, opaque, sealed, and stapled envelopes.
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
Ethic commitee of faculty of medicine. Shahid Beheshti University of Medical Sciences
Street address
Taleghani hospital, Arabi street, Velenjak, Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985711151
Approval date
2023-03-13, 1401/12/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.893
Health conditions studied
1
Description of health condition studied
Infertility in endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
Oocyte and embryo count and quality
Timepoint
One month after the treatment (it is not possible to compare before and after the treatment within groups. we can only compare the two groups after the treatment.)
Method of measurement
Embryologist assessment based on microscopic criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the antagonist protocol, Cinnal-f® (Follitropin alfa) is injected subcutaneously daily from the second day of the cycle, and then when the follicle size reaches 14 mm and at most on day 6, Cetronax 250 mg is injected subcutaneously (Ronak Pharmaceutical Co). This medicine continues with HCG until the trigger day.
Category
Treatment - Drugs
2
Description
Control group: In the agonist protocol, from the 21st day of the previous cycle, Sinnafact with a dose of 50 mg (CinnaGen Co) is injected subcutaneously daily, and from the second day of the cycle, Cinnal-f® (with a dose depending on age and weight and the patient's ovarian reserve) and Cinnafact 20mg are injected daily and subcutaneously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
IVF center, Taleghani hospital
Full name of responsible person
Sedighe Hosseini
Street address
Taleghani hospital, Shahid Arabi Street, Velenjak, Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
taleghanihospital@sbmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedighe Hosseini
Street address
Shahid Arabi street
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
taleghanihospital@sbmu.ac.ir
Grant name
IVF center of Shahid Beheshti University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedighe Hosseini
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Arabi Street
City
Tehran
Province
Tehran
Postal code
1985711161
Phone
+98 21 2303 1111
Email
taleghanihospital@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra Nemati
Position
fellowship assisstant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Arabi Street
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
mithraa.nemati@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra Nemati
Position
Fellowship Assisstant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Arabi Street
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
mithraa.nemati@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
It is not decided yet
When the data will become available and for how long
It is not decided yet
To whom data/document is available
It is not decided yet
Under which criteria data/document could be used
It is not decided yet
From where data/document is obtainable
It is not decided yet
What processes are involved for a request to access data/document