Comparison of the effect of oral dydrogesterone with intramuscular progesterone in supporting the luteal phase in patients undergoing in vitro fertilization treatment, a non-inferiority clinical trial
Comparison of the effect of oral dydrogesterone with intramuscular progesterone in supporting the luteal phase
Design
A randomized, double parallel, single-blind, non-inferiority clinical trial , block-randomized using Sealedenvelope.com website software.
Settings and conduct
The study will be carried out in the Ibn Sina fertility clinic in Tehran. Patients undergoing infertility treatment with in vitro fertilization included in the study criteria during their luteal phase support were randomly divided into two comparison groups of dydrogesterone and intramuscular progesterone, and their clinical pregnancy outcome in the fifth week after embryo transfer will be compared with each other. In this study, the outcome assessor was blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women between 20-40 years old, with a 5-day frozen embryo created by intracytoplasmic sperm injection (ICSI), with a normal uterine cavity. Exclusion criteria: having serious diseases of the uterus and tubes, gender selection cycles or donation
Intervention groups
Dydrogesterone receiving group, intramuscular progesterone receiving group
Main outcome variables
Clinical pregnancy, Chemical pregnancy, Ongoing pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200421047152N5
Registration date:2023-11-25, 1402/09/04
Registration timing:registered_while_recruiting
Last update:2023-11-25, 1402/09/04
Update count:0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
Arash Mohazzab
Name of organization / entity
Avicenna Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2351 9630
Email address
amohazzab@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral dydrogesterone with intramuscular progesterone in supporting the luteal phase in patients undergoing in vitro fertilization treatment, a non-inferiority clinical trial
Public title
The effect of oral dydrogesterone in supporting the luteal phase in patients undergoing in vitro fertilization treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women between 20-40 years old
with a 5-day frozen embryo created by intracytoplasmic sperm injection (ICSI)
Normal uterine cavity
Exclusion criteria:
Follicle stimulating hormone serum level above 12 FSH milliunits/ml
History of endometriosis
History of moderate to severe adenomyosis
History of 3 or more previously failed embryo transfers
Sex selection cycles
Embryo donation cycles or surrogacy
Hydrosalpinx
Any type of uterine abnormalities (septum, etc.)
Submucousal myoma
Asherman syndrome
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
384
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining informed consent, the patients were randomized and divided into two groups of 192 people pretreated with oral dydrogesterone and the other group with progesterone ampoules using permuted block randomization with size of blocks of four by Sealedenvelope.com website software. To conceal the sequence of randomization, it will be given to an independent third person, and the code will be given to the investigator one by one.
Blinding (investigator's opinion)
Single blinded
Blinding description
Since the study outcome will be assessed by someone other than the health care giver, the evaluator records the outcome information without knowing the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Interim analysis will be done after the entry of 200th people with the aim of primary outcome assessment and recalculation of the sample size.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commitee of Avicenna Reserch Institute,ACECR affiliated research institute in biotechnology
Street address
Daneshjou Blvrd. Evin. Chamran Exp.way
City
Tehran
Province
Tehran
Postal code
1985743413
Approval date
2023-11-11, 1402/08/20
Ethics committee reference number
IR.ACECR.AVICENNA.REC.1402.016
Health conditions studied
1
Description of health condition studied
Infertility treated by in Vitro Fertilization
ICD-10 code
Z31.2
ICD-10 code description
In vitro fertilization
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
5 weeks after embryo transfer
Method of measurement
Trans vaginal ultrasound imaging
Secondary outcomes
1
Description
Chemical pregnancy
Timepoint
Day 14 after embryo transfer
Method of measurement
Serum levels of beta human chorionic gonadotropin hormone (Beta HCG)
2
Description
Ongoing pregnancy
Timepoint
12 weeks after embryo transfer
Method of measurement
Trans abdominal ultrasound imaging
Intervention groups
1
Description
Control group: the enrolled patients enter a cycle of 45 days. In this group, the LD pill starts from the third day of menstruation and continues, and on the 21st day of the cycle, Laurelin 1.87 mg ampoule is injected.Then estradiol 2 mg every 8 hours is started on the third day of the next menstrual cycle, and ultrasound is performed 7 to 10 days later. If the thickness of the endometrium is more than 7 mm, progesterone ampoule 50 mg (Fomogex-IH) intramuscularly is prescribed every day to achieve the transformation of the endometrium. In the next stage, embryo transfer is done after 5 days (blastocyst stage embryo) will be done. In women less than 30 years old, one embryo will be transferred, and in women between 30 and 40 years old, two blast embryos will be transferred.
Category
Treatment - Drugs
2
Description
Intervention group:the enrolled patients enter a cycle of 45 days. In this group, the LD pill starts from the third day of menstruation and continues, and on the 21st day of the cycle, Laurelin 1.87 mg ampoule is injected.Then estradiol 2 mg every 8 hours is started on the third day of the next menstrual cycle, and ultrasound is performed 7 to 10 days later. If the thickness of the endometrium is more than 7 mm, then oral dydrogesterone 10 mg three times a day will be prescribed. In the next stage, embryo transfer is done after 5 days (blastocyst stage embryo) will be done. In women less than 30 years old, one embryo will be transferred, and in women between 30 and 40 years old, two blast embryos will be transferred.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Avicenna Fertility Center
Full name of responsible person
Afsaneh Mohamadzadeh
Street address
Yakhchal Junction, Shariati st.
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
info@avicennaclinic.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Mohammad Reza Sadeghi
Street address
Daneshjou Blvrd, Evin
City
Tehran
Province
Tehran
Postal code
1936773493
Phone
+98 21 2243 2020
Email
Sadeghi@avicenna.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
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
Iranian academic center for education culture and research
Full name of responsible person
Somayeh Saleki
Position
Infertiltiy felowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yakhchal Junction , Shariati st.
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
dr.somayeh.saleki2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Afsaneh Mohammadzadeh
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yakhchal Junction , Shariati st.
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
af85af@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Arash Mohazzab
Position
Senior researcher
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Yakhchal Junction , Shariati
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 2351 9630
Fax
Email
amohazzab@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available