This study is a prospective and randomized double-blind clinical trial. The aim of this study is comparison of oral dydrogesterone versus other forms of progesterone as a luteal cycles support in assisted reproductive technology (ART). Total of sample size is 159 patients with ages: 20-50 years old. Inclusion criteria are patients candidate for IVF or ICSI treatment. The patients with abnormal uterus like myoma submucosal, endometrial adhesion and lack of fertilization will be excluded. Patients are randomly divided into three groups with table of random numbers by computer. Patients and Assessor of study do not know about type of drug. This study is trial phaseII. First group receives 10 mg oral dose of Dydrogesterone tablet Three times a day until twelve weeks of pregnancy. Second group receives 400 mg of progesterone vaginal suppository twice a day until twelve weeks of pregnancy. Third group receives 50 mg of intramuscular progesterone twice a day until twelve weeks of pregnancy. Information of patients such as age and BMI, cause of infertility, duration of infertility, the type of ovulation induction (short agonists and long agonist and antagonist), assisted reproductive technique (IVF and ICSI), methods for luteal phase support (intramuscular progesterone and progesterone vaginal suppository and dydrogesterone tablet), endometrial thickness of embryo transferred, grade and the number of transferred embryo cells and amount of live births will be recorded in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010825902N1
Registration date:2016-01-22, 1394/11/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-22, 1394/11/02
Registrant information
Name
Maryam Sadat Ejtahed
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2922
Email address
ejtahed.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-10-18, 1394/07/26
Expected recruitment end date
2016-03-16, 1394/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral dydrogesterone versus other forms of progesterone as a luteal cycles support in assisted reproductive technology (ART)
Public title
The effect of dydrogesterone and various forms of progesterone in support of artificial reproduction techniques
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients candidate for in vitro fertilization (IVF) or intracytoplasmic cytoplasmic sperm injection (ICSI); Having a normal uterus. Exclusion Criteria: Abnormal uterus such as submucosal myoma and endometrial adhesions; Sensitivity to progesterone; Lack of fertilization; Having a systemic disease.
Age
From 20 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
159
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Initially, all patients are placed under transvaginal ultrasound then appropriate drugs is prescribed to patient for stimulation of ovulation based on patient cycle (short agonists and long agonist and antagonist). Transvaginal ultrasound is repeated once every five days. HCG will be prescribed when at least three follicles reach a diameter of over 18 mm. Ovum retrieval is done by transvaginal 36 hours after the injection HCG. In all patients will be prescribed dydrogesterone and progesterone for luteal phase support since ovum retrieval based on grouping patients. Embryo in the third to fifth day after ovum retrieval will be transferred to each patient with the number and grade of different. The criterion standard for pregnancy test is defined by a serum positive HCG on twelfth day after the fetal transfer and viewing the fetal heart on ultrasound.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
Approval date
2015-10-17, 1394/07/25
Ethics committee reference number
IR.AJUMS.AC.1394.417
Health conditions studied
1
Description of health condition studied
Artificial fertilization
ICD-10 code
N98.2
ICD-10 code description
Complications of attempted introduction of fertilized ovum following in vitro fertilization
Primary outcomes
1
Description
Pregnancy
Timepoint
Once a week after embryo transfer into the patient
Method of measurement
The blood hCG test
2
Description
Preterm delivery
Timepoint
Every two weeks from the twentieth week of pregnancy
Method of measurement
Patient appointments and record uterine contractions
3
Description
Amount of live birth
Timepoint
Every two weeks from twenty-eighth week of pregnancy
Method of measurement
Patient appointments and record baby's birth
4
Description
Grade and the number of transferred embryo cells
Timepoint
Immediately before embryo transfer into the patient
Method of measurement
By using microscope
Secondary outcomes
1
Description
Perineal irritation caused by progesterone vaginal suppository
Timepoint
Every two weeks during treatment period
Method of measurement
Verbal questionnaire and the patient's response
Intervention groups
1
Description
Intervention group 1: Prescription oral dose of 10 mg of dydrogesterone, Three times a day, since ovum retrieval until the twelfth week of pregnancy.
Category
Treatment - Drugs
2
Description
Intervention group 2: Prescription 400 mg of progesterone vaginal suppository, twice a day, since ovum retrieval until the twelfth week of pregnancy.
Category
Treatment - Drugs
3
Description
Control group: Prescription 50 mg of intramuscular progesterone, twice a day, since ovum retrieval until the twelfth week of pregnancy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Treatment Center of University ACECR of Khuzestan
Full name of responsible person
Najmieh Saadati
Street address
Infertility Treatment Center of University ACECR of Khuzestan, Pardis Blv, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Maryam Sadat Ejtahed
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
dr.maryamejtahed@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mahvash Zargar
Position
Fellowship of Infertility of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
dr.zargar199@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sanaz Nazari
Position
Nurse Anesthesia
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
-
Phone
00
Fax
-
Email
s.nz1990@yahoo.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)