Determining and comparing the effectiveness of cyclogest and duphaston in supporting the luteal phase of infertility patients
Design
Randomized, no-blinding clinical trial, with the parallel groups, phase 2 on 126 patients
Settings and conduct
In this randomized clinical trial study, 126 infertility patients referred to Beheshti Hospital in Isfahan will be included in the study and randomly divided into 2 groups. Patients in one group receive dydrogesterone tablets and in the other group receive progesterone suppositories. Then the clinical pregnancy rate, chemical pregnancy and Beta human chorionic gonadotropin will be compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include age 20-40 years old; history of infertility and candidate for IVF treatment; having a normal endometrial thickness (7 to 12 mm) and consent to participate in the study. Exclusion criteria include pelvic density adhesion; advanced endometriosis, and genital tuberculosis.
Intervention groups
Intervention group 1: patients in this group are treated with dydrogesterone tablets (Duphaston 10 mg) (Abbott Company, Netherlands) every 12 hours for 12 weeks after embryo transfer.
Intervention group 2: patients in this group are treated with vaginal progesterone suppository 400 mg (cyclogest 400 mg) (Hector Company, United Kingdom) every 12 hours for 12 weeks after embryo transfer.
Main outcome variables
Clinical pregnancy rate; chemical pregnancy; Beta human chorionic gonadotropin(Beta-HCG)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N32
Registration date:2021-05-10, 1400/02/20
Registration timing:prospective
Last update:2021-05-10, 1400/02/20
Update count:0
Registration date
2021-05-10, 1400/02/20
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of cyclogest and duphaston in supporting the luteal phase of infertility patients
Public title
The effectiveness of cyclogest and duphaston in supporting the luteal phase of infertility patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40-20 years old
History of infertility and candidate for IVF treatment
Normal endometrial thickness (7 to 12 mm)
Consent to participate in the study
Exclusion criteria:
Having pelvic density adhesion
Having advanced endometriosis
Having genital tuberculosis
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 126 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". We randomly divide these numbers into two parts. Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups.
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 committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-02-01, 1398/11/12
Ethics committee reference number
IR.MUI.MED.REC.1398.560
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
Five weeks after the start of the intervention
Method of measurement
Vaginal ultrasound of the uterus
2
Description
Chemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
Laboratory kit
3
Description
Beta human chorionic gonadotropin(Beta-HCG)
Timepoint
Two weeks after embryo transfer
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention first group: patients in this group are treated with dydrogesterone tablets (Duphaston 10 mg) (Abbott Company, Netherlands) every 12 hours for 12 weeks after embryo transfer.
Category
Treatment - Drugs
2
Description
Intervention second group: patients in this group are treated with vaginal progesterone suppository 400 mg (cyclogest 400 mg) (Hector Company, United Kingdom) every 12 hours for 12 weeks after embryo transfer.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Hatav Ghasemi Tehrani
Street address
Motahari Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3234 6338
Email
Hatav.tehrani2014@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hatav Ghasemi Tehrani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Al-Zahra Hospital, Sofeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
Hatav.tehrani2014@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hatav Ghasemi Tehrani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Al-Zahra Hospital, Sofeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
Hatav.tehrani2014@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Sharifian
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Al-Zahra Hospital, Sofeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
Drsharifian.f@gmail.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