Comparison of r hCG with r hCG plus GNRH agonist for triggering ovulation in poor responder endometriotic patients candidate for ICSI cycles at Yas hospital
Design
A placebo-controlled, not blind clinical trial, phase 3, 200 patients, randomized using rand function of Excel software.
Settings and conduct
Patients who refer to Yas IVF clinic candidate for ICSI will receive gonadotropin for induction of ovulation and fixed antagonist protocol will be started, induction continued until at least one 18 mm follicle will be occurred at the vaginal ultrasound, then for triggering of ovulation rhCG and placebo in the control group will be injected and in the case group, rhCG plus 0.2 mg GNRH agonist will be injected, 36 hours later oocyte puncture will be performed. Finally, the outcome of the cycle will be evaluated by numbers of MII OOCYTES, good quality embryos, chemical and clinical pregnancy, abortion.
Participants/Inclusion and exclusion criteria
Infertile endometrioric patients; AMH <1/1ng/ml; AFC <5; Candidate for IVF
Intervention groups
Intervention group 1: r-hCG is injected.
Intervention group 2: r-hCG plus two ampoule Gnrh_agonist0.1 is injected.
Main outcome variables
Numbers of MII oocytes; Numbers of good quality embryos ;chemical pregnancy ( positive BhCG test);
clinical pregnancy ( gestational sac at Transvaginal sonagraphy)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N22
Registration date:2022-02-15, 1400/11/26
Registration timing:registered_while_recruiting
Last update:2022-02-15, 1400/11/26
Update count:0
Registration date
2022-02-15, 1400/11/26
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-04, 1400/11/15
Expected recruitment end date
2023-02-04, 1401/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of recombinant hCG with recombinant hCG plus Gnrh agonist for triggering ovulation in ICSI Cycles of poor responder endometrioric patients
Public title
Comparison of r- hCG with r- hCG plus Gnrh- a for poor responder endometrioric patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile endometrioric patients
AMH <1/1ng/ml
AFC <5
Candidate for IVF
Random allocation rule: First 100 letters A and 100 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (case group) or B (control group) are determined by a lot.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of medical sciences
Street address
Yas hospital. S arv Aven., North Nej atollahi Street,Karim khan zand Bridge,Villa street,Tehran
City
Tehran
Province
Tehran
Postal code
15978
Approval date
2022-02-09, 1400/11/20
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1257
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.8
ICD-10 code description
Female infertility of other origin
Primary outcomes
1
Description
Pregnancy
Timepoint
BhCG levels two weeks after embryo transfer
Method of measurement
BhCG levels mg/ml
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
Finding gestational sac at vaginal sonography three weeks after embryo transfer
Method of measurement
Numbers of gestational sac at transvaginal ultrasound three weeks after embryo transfer
Intervention groups
1
Description
Intervention group: One_ hundred infertile endometriotic patients who are Candidate for ICSI, will prescribed rhCG plus 0.2 Agonist Gnrh for triggering of ovulation
Category
Treatment - Drugs
2
Description
Control group: One_ hundred infertile endometriotic patients who are Candidate for ICSI, will prescribed rhCG plus placebo for triggering of ovulation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
One_ hundred infertile endometriotic patients who are Candidate for ICSI, will prescribed rhCG for t
Full name of responsible person
Dr. Fatemeh Davari Tanha
Street address
Yas Hospital- Sarv Ave. North Nejatallahi street, Krim khan hand bridge,Villa street
City
Tehran
Province
Tehran
Postal code
15978
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mis . Mostofi
Street address
Research Deputy - 5th floor. Central building of Tehran university o f medical sciences - chods ave. keshavari Boalvar
City
Tehran
Province
Tehran
Postal code
15978
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
professor of Tehran university of medical sciences
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Nejatollahi ,villa street
City
Tehran
Province
Tehran
Postal code
159 78
Phone
+98 21 8880 0115
Email
fatedavtanha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North nejatollahi,villa Street, Karim khan zand Bridge
City
Tehran
Province
Tehran
Postal code
1597815978 88
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Nejatollahi Ave. Villa street, Karim khan zand Bridge
City
Tehran
Province
Tehran
Postal code
159781597888
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.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