Evaluate the effect of using dydrogesterone and its comparison with Gonadotropin-releasing hormone( GnRH) on induction of ovulation in IVF patients.
Design
Parallel intervention study, type of randomized clinical trial, on 200 patients. Patients are randomly divided into two groups of Intervention and Control group by using the random numbers table.
Settings and conduct
A clinical trial study on 200 infertile women who are candidates for IVF in the Vali Asr Infertility Center of Tehran University of Medical Sciences. A random-simple-double-blind method using a random numbers table which the researcher selects to read the numbers from top to bottom and then considers the pair numbers for the intervention group and the individual numbers for the control group. Participants and researchers or evaluators are not aware of the allocation of the study group
Participants/Inclusion and exclusion criteria
Infertility candidates for IVF, aged less than 40 years, AMH greater than 1.5 ng / Ml; in the first or second cycles of VF; are the inclusion criteria and
Cigarette smoking, having the uterine anomalies; uncontrolled thyroid or adrenal insufficiency; endometriosis grade 3 or more; couples' chromosomal abnormalities; underlying disorders leading to ovulation disorders are the exclusion criteria.
Intervention groups
Study group: On 2-3 days of menstrual cycle, oral progesterone or dydrogesterone (Duphaston 20 mg daily, oral) and hMG (225-150 units per day) are prescribed for 10 to 12 hours, then decapeptide 0.2 cc is given.
Control group: On day 2-3 of the menstrual cycles, the hMG (225-150 injectable unit daily) and the antagonist Cetrotide (GnRH, 0.25 mg) are injected subcutaneously every 24 seconds, given for 10-12 days, and Decapeptide will then be administered at 0.2 cc.
Main outcome variables
Number of the mature oocytes, LH surge
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181031041519N2
Registration date:2019-06-10, 1398/03/20
Registration timing:registered_while_recruiting
Last update:2019-06-10, 1398/03/20
Update count:0
Registration date
2019-06-10, 1398/03/20
Registrant information
Name
Seyyedeh Tahere Ghazimirsaeed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8825 8831
Email address
ghazimirsaeed.st@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-05, 1398/03/15
Expected recruitment end date
2020-04-03, 1399/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the use of dydrogesterone and GnRH antagonists in InVitro Fertilization (IVF) cycles.
Public title
Comparison the use of dyrogesterone and steroid in IVF Cycles.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile patients candidates for IVF
AMH greater than 1 ng / ml
First or second IVF cycle
The presence of both ovaries
Age less than 40 years
Exclusion criteria:
Smoking
Presence of uterine anomalies
Adrenal insufficiency or uncontrolled thyroid
Endometriosis grade 3 or More
Couples chromosomal disorder
Underlying disorder that can lead to ovulatory dysfunction
Repeated failure of IVF
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:
200
Randomization (investigator's opinion)
Randomized
Randomization description
A random method using a random numbers table which the researcher selects to read the numbers from top to bottom and on one of the numbers she places her finger and moves up and down and records the numbers that consider the pair numbers for the intervention group (A) and the individual numbers for the control group (B).
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
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Sixth Floor, Quds Building, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14194
Approval date
2019-02-19, 1397/11/30
Ethics committee reference number
IR.TUMS.VCR.REC.1398.172
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Number of mature oocyte
Timepoint
Two weeks after treatment
Method of measurement
Vaginal sonography
Secondary outcomes
1
Description
LH surge
Timepoint
Two weeks after treatment
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: Group A (study group): On the second day of the menstrual cycle, all patients undergo vaginal sonography, and in the absence of follicles greater than 10 mm, the treatment cycle begins. Patients receive oral progesterone or dydrogesterone (Duphaston, 20 mg daily, oral). Six days after the start of treatment, vaginal sonography will be performed. At the same time as starting dydrogesterone (2-3 cycles a day), hMG (225-150 units injected daily) is prescribed. In case of appearance, 2 follicles of 18 mm and 3 follicles of 14-15 mm in ultrasound, for the trigger, decapeptide, will be administered at 0.2 cc. It is worth mentioning that taking dydrogesterone is stopped on the trigger day.
Category
Treatment - Drugs
2
Description
Control group: Group B (control): hMG 225-150 injectable units daily) received in 2-3 cycles of menstruation and after administration of hMG, when the follicle reached 13 mm, the Cetrotide antagonist (GnRh, 0.25 mg), It is injected subcutaneously every 24 hours. In case of appearance, 2 follicles of 18 mm and 3 follicles in 14-15 mm in ultrasound, for a trigger, decapeptide, will be prescribed to 0.2 cc. And the antagonist (steroid) injection stops. 36-39 hours after decapeptide injection, ovule collection (OPU, Ovum Pick up) will be done in both groups. n (OPU, Ovum Pick up) will be done in both groups. The ovum obtained is categorized in terms of growth by the embryologist. And 2-3 days after the ICSI, embryos are graded by the number of cells and fragmentation by the specialist. In the next cycle, then in each patient, 2 embryos will be transmitted from the best embryos of good quality (embryos with high blastomeres and without fragmentation) and the embryo transfer will be carried out by one person from the infertility fellowship without knowledge of the patient groups.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Clinic,Vali Asr Hospital,Imam Khomeini Hospital.
Full name of responsible person
Seyede Masoumeh Ghazi Mirsaeed
Street address
Keshavarz BLvd,Vali Asr Hospital,Infertility Clinic
City
Tehran
Province
Tehran
Postal code
14194
Phone
+98 21 6693 9320
Email
dr_ghazi82@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Sahraean
Street address
Tehran University of Medical Sciences, Sixth Floor, Quds Building, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14194
Phone
+98 21 8163 3619
Email
dr.sahraeean@sina.tums.ac.ir
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
Seyede Masoumeh Ghazi Mirsaeed
Position
Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Infertility
Street address
Infertility Clinic,Vali Asr Hospital, ImamKhomeini Hospital Complex, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14194
Phone
+98 21 6693 9320
Email
dr_ghazi82@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Batool Hossein Rashidi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Infertility
Street address
Infertility Clinic, Vali Asr Hospital, ImamKhomeini Hospital Complex, Keshavarz Blvd.,
City
Tehran
Province
Tehran
Postal code
14194
Phone
+98 21 6693 9320
Email
bhrashidi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyede Masoumeh Ghazi Mirsaeed
Position
Infertility Flowship
Latest degree
Specialist
Other areas of specialty/work
Infertility
Street address
Infertility Clinic, Vali Asr Hospital, Imam Hospital Complex, Keshavarz Blvd.,
City
Tehran
Province
Tehran
Postal code
14194
Phone
+98 21 6693 9320
Email
dr_ghazi82@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