Protocol summary

Study aim
To investigate the results of ICSI in divided doses of GNRH agonist as a trigger for hyperresponders.
Design
Randomized cotrolled trial with panrallel groups, single blind on 122 samples. Sealedenvelope.com was used for randomization.
Settings and conduct
Patients referring to Avicenna Infertility Center will be treated for infertility through ICSI in two treatment groups with two different drug regimens, and the results will be compared with each other. Outcome assessors are blinded to the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: age 18 to 39 years, according to the definition of excessive respondents (more equal to 17 follicles above equal to 11 mm per trigger day), body mass index 18-30 kg/m2, presence of both ovaries, Indications for intracytoplasmic sperm injection, stimulation in a gonadotropin-releasing hormone (GnRHa) protocol Exclusion criteria include: human chorionic gonadotropin (hCG) stimulated cycles, donor cycles, severe male factor with sperm count below two million, patients with hypogonadotrophic hypogonadism and uterine abnormalities, unwillingness to participate in the study.
Intervention groups
Group A: 0.3 mg of gonadotropin-releasing hormone agonist 36 hours before ovulation and LH is measured on the third day of the cycle and 12 hours after trigger injection and on the day of ovarian puncture. Group B: 0.2 mg of agonist 36 hours before ovulation plus a repeat dose of 0.1 mg of agonist 24 hours after the first dose is administered to approach the body's physiological surge pattern.
Main outcome variables
The number of germinal vesicle (GV) oocytes and metaphase one and two metaphase oocytes, fertilization rate, clinical pregnancy rate, number of quality embryos, ovarian hyperstimulation syndrome rate and empty follicle syndrome rate.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240426061578N1
Registration date: 2024-05-28, 1403/03/08
Registration timing: prospective

Last update: 2024-05-28, 1403/03/08
Update count: 0
Registration date
2024-05-28, 1403/03/08
Registrant information
Name
zahra takhti
Name of organization / entity
Avicenna institute
Country
Iran (Islamic Republic of)
Phone
+98 21 23519
Email address
z1021186@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-09, 1403/03/20
Expected recruitment end date
2024-08-10, 1403/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of single vs. divided dose of gonadotropin-releasing hormone agonist (GNRHa) as a trigger in overresponding patients undergoing intracytoplasmic sperm injection (ICSI)
Public title
Comparison of the efficacy of a single dose of gonadotropin-releasing hormone agonist with its divided dose on the results of intracytoplasmic injection of sperm
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
More or equal to 15 follicles above 11 mm per trigger day Indication for intracytoplasmic sperm injection (ICSI ) Body mass index 18-30 The presence of any two ovaries
Exclusion criteria:
Cycles stimulated with human chorionic gonadotropin (HCG) Donation cycles using GNRH stimulation Severe male factor with sperm count below 2 million Patients with hypogonadism Uterine abnormalities
Age
From 20 years old to 39 years old
Gender
Female
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 122
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done as stratified blocked randomization. Block randomization with a variable block size of 4, 6, and 8 based on the age of the patients (with a cutoff of 32 years) and using the software of the sealedenvelope website. Com will be done. In order to hide the random sequence, it will be given to a third indipendent person, and will be revealed one by one at the start of each patient's cycle.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessors, who will be the embryology laboratory expert and the doctor evaluating the patient's clinical pregnancy status, will not know the type of assigned group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Ibn Sina Research Institute
Street address
Avinenna Research., Shahid Beheshti University., Darake St
City
Tehran
Province
Tehran
Postal code
1983969412
Approval date
2024-04-09, 1403/01/21
Ethics committee reference number
IR.ACECR.AVICENNA.REC.1403.001

Health conditions studied

1

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

Primary outcomes

1

Description
Number of high quality embryos
Timepoint
2 days after conception
Method of measurement
Embryology laboratory

Secondary outcomes

1

Description
Fertility rate
Timepoint
7 days after ICSI
Method of measurement
Embryology report

Intervention groups

1

Description
Intervention group A - Trigger method of group A: two ampoules of Deca Peptide (0.1) are injected 36 hours before the puncture and the second dose is injected 24 hours after the first dose. Luteal hormone (LH) is checked 12 hours after the first dose and on the day of puncture
Category
Treatment - Drugs

2

Description
Intervention group B: trigger method group B: three ampoules of decapeptide 0.1 are injected at the same time 36 hours before the puncture. LH is checked on the day of the puncture.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibn Sina Infertility Treatment Center
Full name of responsible person
Soheila Ansaripoor
Street address
No. 97, Yakhchal Ave., Shariati St
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
Soh.ansaripour@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Avicenna Research Institute
Full name of responsible person
Ramin Ghahremanzadeh
Street address
Daneshjou Boulvard, Evin
City
Tehran
Province
Tehran
Postal code
1314744513
Phone
+98 21 2243 2020
Email
info@avicennaclinic.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Avicenna Research Institute
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
Avicenna Infertility Clinic
Full name of responsible person
Soheila Ansaripoor
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 97, Yakhchal Ave., Shariati St
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
Soh.ansaripoor@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Avicenna Fertility Clinic
Full name of responsible person
Soheila ansaripoor
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 97, Yakhchal Ave., Shariati St
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
soh.ansaripoor@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
َAvicenna Fertility Clinic
Full name of responsible person
Zahra Takhti
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
N0. 97, Yakhchal Ave., Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
Z1021186@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Simultaneously with the presentation of the article, all the documents of the plan will be published
When the data will become available and for how long
After printing the article
To whom data/document is available
All researchers working in scientific institutions
Under which criteria data/document could be used
Documents and data can be provided upon request of researchers
From where data/document is obtainable
The postal address and email address of two project managers will be available
What processes are involved for a request to access data/document
Documents can be provided by e-mail or correspondence with the project manager
Comments
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