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:
2024-01-13, 1402/10/23
Update count:
2
-
Registration date
-
2018-10-15, 1397/07/23
-
Registrant information
-
-
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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2018-09-16, 1397/06/25
-
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.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Babol 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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
There is still no plan for its puplish.
-
Study Protocol
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available