Evaluation and comparison of luteal phase support with vaginal and oral progesterone in IUI
Design
Interventional clinical trial with control and parallel groups, non-blind, randomized, phase 2 will performed on 288 patients. Randomization will performed using random number table.
Settings and conduct
The objective of this study is Evaluation and comparison of luteal phase support with vaginal and oral progesterone in IUI in Kernan in 2022. Study population: Infertile women 18 to 40 years of age with unexplained infertility, mild male infertility, or due to polycystic ovary syndrome who have not responded to drug treatment alone and are candidates for intrauterine insemination. Study groups: Intervention and control groups. Sample size: 288 women. This is a randomized not blinded trial, in one center, in phase 2 study. Setting and conduct: Infertile women who are candidates for IUI after obtaining informed consent randomized into intervention and control groups.
Participants/Inclusion and exclusion criteria
Infertile women 18 to 40 years of age with unexplained infertility, mild male infertility, or due to polycystic ovary syndrome who have not responded to drug treatment alone and are candidates for intrauterine insemination.
Intervention groups
In the intervention group, after intrauterine insemination, 10 mg of oral dydrogesterone (Duphaston) is used three times a day to support the luteal phase.
In the control group, progesterone suppository called vaginal cyclogest 400 micrograms is prescribed twice a day.
Main outcome variables
Chemical pregnancy, clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151004024335N5
Registration date:2022-08-09, 1401/05/18
Registration timing:registered_while_recruiting
Last update:2022-08-09, 1401/05/18
Update count:0
Registration date
2022-08-09, 1401/05/18
Registrant information
Name
robabe hoseinisadat
Name of organization / entity
infertility institute center of shahid sadughi
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 7085
Email address
robabehoseini@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of luteal phase support with vaginal and oral progesterone in IUI
Public title
Evaluation and comparison of luteal phase support with vaginal and oral progesterone in IUI in Kernan in 2022
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with unexplained infertility
Infertility with a mild male factor
Infertility due to polycystic ovary syndrome who have not responded to drug treatment alone
Age 18 to 40 years
Exclusion criteria:
Three times more history of unsuccessful intra uterine sperm insemination treatment
azoospermia or Severe spermogram disorder
Presence of endocrine diseases such as diabetes and severe thyroid disease
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
288
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was simple, individual, not blinded, using a random number table.
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 comittee of Kerman University of Medical Sciences
Street address
Ibn Sina Street, Jahad Boulevard, Somayeh Road (Tahmasebabad)
City
kerman
Province
Kerman
Postal code
7619813159
Approval date
2022-07-19, 1401/04/28
Ethics committee reference number
IR.KMU.AH.REC.1401.072
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
Measurement of serum beta-HCG
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
Five weeks after embryo transfer
Method of measurement
Transvaginal ultrasound
2
Description
miscarriage rate
Timepoint
miscarriages before 20 weeks gestation
Method of measurement
Contact patients at the 20th week of pregnancy
Intervention groups
1
Description
Intervention group: Intervention group: To start the IUI cycle, women are given ovulation-stimulating drugs in the form of letrozole or clomiphene tablets for five days from the third day of the menstrual cycle. Then, from the eighth day, the gonadotropin cycle starts with a dose of 150-175 units. On the eleventh day of the menstrual cycle, transvaginal ultrasound is performed to monitor the follicle. Depending on the size of the follicle, the drug is continued and the ultrasound is repeated until one or two follicles reach a size of 18 mm. If more than two follicles grow due to increased risk of multiple pregnancy or ovarian hyperstimulation, the cycle will be canceled. When the follicle size reaches 18 mm, 10,000 units of human chorionic gonadotropin (HCG) are used to stimulate ovulation. 36 hours after HCG injection, the partner's sperm is prepared by the infertility center laboratory and inseminated into the endometrial cavity with a sterile catheter by the infertility fellowship. Patients are then randomly divided into two groups. In the intervention group, which will consist of 144 women, oral diderogesterone tablets under the Dofaston brand are given as 10 mg three times a day and continue until the 11th week of pregnancy.
Category
Treatment - Drugs
2
Description
Control group: In the control group, after intrauterine insemination of sperm, a progesterone suppository called vaginal cyclogest 400 micrograms is administered twice a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Infertility Center
Full name of responsible person
Dr Robabe Hosseinisadat
Street address
Imam Khomeini Highway, Afzalipour Hospital
City
kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8486
Email
robabehosseinisadat@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Research Assistant, Kerman University of Medical Sciences
Street address
Ibn Sina Street, Jahad Boulevard, Somayeh Road (Tahmasebabad)
City
kermman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
robabehosseinisadat@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Robabe Hosseinisadat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
infertility
Street address
Imam Khomeini Highway, Afzalipour Hospital
City
kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8486
Email
robabehosseinisadat@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Robabe Hosseinisadat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
infertility
Street address
Imam Khomeini Highway, Afzalipour Hospital
City
kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8486
Email
robabehosseinisadat@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Robabe Hosseinisadat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
infertility
Street address
Imam Khomeini Highway, Afzalipour Hospital
City
kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8486
Email
robabehosseinisadat@yahoo.com
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
The final result of the study will be published and there is no need to share individual participants' data
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