Comparison of the efficacy of two therapeutic methods of use of dydrogesterone and vaginal progestrein as a luteal cycles support in Assisted Reproductive Technology (ART) in patients referring to Fateme Zahra infertility center in Babol
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General information
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207
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2019-03-01, 1397/12/10
2020-02-29, 1398/12/10
20192020-0302-0129 00:00:00
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2018-10-02, 1397/07/10
2018-10-02 00:00:00
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2020-02-29, 1398/12/10
2020-02-29 00:00:00
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2020-02-29, 1398/12/10
2020-02-29 00:00:00
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Sampling completion date
Sampling completion date
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تاریخ اتمام نمونه گیری
تاریخ اتمام نمونه گیری
Protocol summary
Study aim
Comparison of the efficacy of two therapeutic methods of use of dydrogesterone and vaginal progestrein as a luteal cycles support in Assisted Reproductive Technology (ART)
Design
A single-blind clinical trial with parallel groups. 210 patients have randomly divided into intervention and control groups with a table of random numbers and Randomizer software.
Settings and conduct
The population of this study was infertile women aged 20-40 years old who referred to Fatemeh Al-Zahra infertility center in Babol. Patients are randomly divided into two groups with a table of random numbers by computer. The first intervention group receives 400 mg vaginal suppository once a day. The second intervention group receives oral progesterone-duphaston 20 mg twice a day. The medications are prepared quite similar in appearance (color and shape), sealed in opaque envelopes with consecutive numbers. The researcher is aware of numbers
Participants/Inclusion and exclusion criteria
Inclusion criteria: 20-40 years old, Body Mass Index 30-18 Kg/m2, Endometrium Thickness 7-14 mm
Exclusion criteria: Abnormal prolactin serum level and abnormal thyroid function test, Diminished ovarian reserve (baseline FSH level >10 IU/mL)
Intervention groups
Control group: Receiving 400 mg vaginal suppository once a day
Intervention group: Receiving oral progesterone-duphaston 20 mg twice a day
Main outcome variables
Determining the incidence of pregnancy in two methods of dystrogesterone and vaginal progesterone
General information
Reason for update
Sampling completion date
Acronym
IRCT registration information
IRCT registration number:IRCT20170205032406N2
Registration date:2018-10-15, 1397/07/23
Registration timing:registered_while_recruiting
Last update:2024-01-03, 1402/10/13
Update count:2
Registration date
2018-10-15, 1397/07/23
Registrant information
Name
Maryam Javadian Kootenaei
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 2334
Email address
m.javadian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-02, 1397/07/10
Expected recruitment end date
2020-02-29, 1398/12/10
Actual recruitment start date
2018-10-02, 1397/07/10
Actual recruitment end date
2020-02-29, 1398/12/10
Trial completion date
2020-02-29, 1398/12/10
Scientific title
Comparison of the efficacy of two therapeutic methods of use of dydrogesterone and vaginal progestrein as a luteal cycles support in Assisted Reproductive Technology (ART) in patients referring to Fateme Zahra infertility center in Babol
Public title
The effect of dydrogesterone and vaginal progestrein in support of artificial reproduction techniques
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20-40 years old
Body Mass Index 18-30 kg/m2
Endometrium Thickness 7-14 mm
Exclusion criteria:
Abnormal prolactin serum level and abnormal thyroid function test
Diminished ovarian reserve ( baseline FSH level >10 IU/mL)
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
210
Actual sample size reached:
207
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients into two intervention groups Patients are randomly divided into two groups A (dydrogesterone), B (vaginal progestin) with a table of random number s (a random number table is a collection of numbers that are generated without a specific pattern or order and completely randomized, then samples are randomly selected by Randomizer software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants are unaware of the type of intervention (dydrogesterone or vaginal progestin) given to every participant.
The medications are prepared quite similar in appearance (color
and shape), sealed in opaque envelopes with consecutive numbers. The researcher is aware of numbers.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Approval date
2018-10-01, 1397/07/09
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.151
Health conditions studied
1
Description of health condition studied
In vitro 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
Secondary outcomes
1
Description
Preterm delivery
Timepoint
Every two weeks from the twentieth week of pregnancy
Method of measurement
Patient visit and record uterine contractions
2
Description
Amount of live birth
Timepoint
Every two weeks from twenty-eighth week of pregnancy
Method of measurement
Patient visit and record baby's birth
3
Description
Abortion
Timepoint
Six weeks after intervention
Method of measurement
Sonography and pregnancy test
Intervention groups
1
Description
Control group: Receives 400 mg vaginal suppository once a day began on the day of oocyte retrieval and was continued up to 12 weeks of pregnancy.
Category
Treatment - Drugs
2
Description
Intervention group: receives oral progesterone-duphaston 20 mg twice a day. began on the day of oocyte retrieval and was continued up to 12 weeks of pregnancy.