Evaluation of serum progesterone level on third day after intrauterine insemination on pregnancy outcomes in two routes of luteal phase support in women with unexplained infertility : A randomized clinical trial study.
Evaluation of serum progesterone level on third day after IUI on pregnancy outcomes in two methods of luteal phase support in women with unexplained infertility
Design
One-blind clinical trial with random assignment to the intervention group (receiving Crinone vaginal gel) and control (receiving Duphaston), the third phase of the trial on 70 infertile patients, randomization before the start of the study with Random allocation software function, IUI, assessment of pregnancy outcomes at the end of the study
Settings and conduct
On IUI day, all patients are randomly divided into two groups: intervention: receiving 90 mg / once daily vaginal crinone gel 8% , control group: receiving Duphaston 10 mg twice daily (oral form of progesterone) in all Patients continue to support the luteal phase until pregnancy testing, 14 days after IUI. Serum progesterone levels are measured in all patients 72 hours after IUI and pregnancy outcomes including biochemical pregnancy, clinical pregnancy, ongoing pregnancy, abortion in each patient are evaluated and the relationship between serum progesterone levels on the third day after IUI and these outcomes in each patient will be examined.
Participants/Inclusion and exclusion criteria
General admission requirements:
Age range 18-37
IUI cycles
Patients with normal uterine cavity
Exclusion criteria:
Patients with uterine problems such as fibroids; anatomical problems of the uterus, polyps; salpingitis
Patients with a history of recurrent miscarriage
RIF patients
Age over 37 years
Patients with grade 3 or 4 endometriosis
Body mass index higher than 30 kg / m2
Patients with endometrial thickness less than 7 mm per day trigger
Intervention groups
A: receiving 90 mg / once daily vaginal crinone gel 8%) B: receiving Duphaston aston 10 mg twice daily (oral form of progesterone)
Evaluation of serum progesterone level on third day after intrauterine insemination on pregnancy outcomes in two routes of luteal phase support in women with unexplained infertility : A randomized clinical trial study.
Public title
The effect of serum progesterone on third day after intrauterine insemination (IUI) on pregnancy outcomes in two different methods of progesterone administration
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
IUI cycles
Patients with normal uterine cavity
Exclusion criteria:
Patients with uterine abnormalities such as myoma, anatomical problems, polyp, salpangitis
Patients with a history of recurrent miscarriage
Age over 37 years old
Patients with grade 3 or 4 endometriosis
BMI over 30 kg/m2
Previous ectopic pregnancy
Usage two type of progesterone for luteal phase support
Endometrial thickness lower than 7mm on trigger day
Age
From 18 years old to 37 years old
Gender
Female
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly allocate the samples to each of the study groups, Random allocation software was used, which generated a random sequence using a single block method.
The address of the software is as follows:
https://random-allocation-software.software.informer.com/2.0/.
How to randomize: This software according to the uniform statistical distribution of discrete sequence in the form of letters (or numerical) in the form of ... ABAABAABABBA produces that each letter belongs to a group to hide
In order to hide the random allocation so that the assigned group is not known before the individual is assigned, each of the random sequences created is recorded on a card and the cards are placed in the envelopes , respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes is opened in order and the assigned group of the participant is revealed.
How to use the software by installing the software file and after opening it, first the number of groups is determined, then the sample size of each group and finally the method of numerical or letter randomization is selected in a simple or block form. In this study, the method A block was selected.
Blinding (investigator's opinion)
Single blinded
Blinding description
This research is a one-blind study. Thus, the person analyzing the results is unaware of the status of allocation in groups. R
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical board of Hormozgan University of Medical Sciences
Street address
Parastar Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2021-06-13, 1400/03/23
Ethics committee reference number
IR.HUMS.REC.1400.100
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Biochemical pregnancy
Timepoint
14 days after IUI
Method of measurement
Beta serum level evaluation
2
Description
Biochemical pregnancy
Timepoint
8 weeks after IUI
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:receiving vaginal progesterone( crinone gel 8%), Crinone gel contains 90 mg of progesterone and is consumed once a day for 14 days.
Category
Treatment - Drugs
2
Description
Control group: receiving Progesterone in the form of Duphaston 10 mg tablets, for 14 days and twice a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility center of Hormozgan University of Medical Sciences
Full name of responsible person
Dr.Maryam Azizi kutenaee
Street address
Parastar street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 0755
Email
maryamazizikut86@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr.taymoor Aghamolaee
Street address
Parastar Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 7610
Email
research@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Maryam azizi kutenaee
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Parastar Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 0755
Email
maryamazizikut86@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr.Maryam azizi kutenaee
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Parastar Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 0755
Email
maryamazizikut86@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr.Ensieh salehi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Parastar Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 0755
Email
salehiensieh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data will be presented in the article after analysis
When the data will become available and for how long
2022
To whom data/document is available
Academic researchers and obstetricians
Under which criteria data/document could be used
Clinical application in patients undergoing IUI
From where data/document is obtainable
Paper corresponding author
What processes are involved for a request to access data/document