To investigate the use of medroxyprogesterone acetate (MPA) to prevent LH surge during controlled ovarian hyperstimulation in IVF cycles
Design
This study is a double-blind randomized clinical trial, in which 100 eligible patients will be randomly assigned to the intervention and control groups.
Settings and conduct
The eligible patients with infertility who are candidates for IVF at Zeinabye Hospital of Shiraz University of Medical Sciences will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the simple randomization.
Participants/Inclusion and exclusion criteria
inclusion criteria:
age under 42 years
regular menstrual cycles over the previous 3-month period
antral follicle count (AFC) of 7-24 on menstrual cycle day 2–3
Normal TSH and Prolactin levels
Exclusion criteria:
endometriosis grade 3 or higher
diagnosis of polycystic ovarian syndrome
presence of the ovarian cyst
hormone treatment receipt within the previous 3-month period
low ovarian reserve (AMH<1.1 or AFC<7)
any contraindication to ovarian stimulation treatment
basal serum FSH concentration of more than 10 IU/L
Intervention groups
Intervention Group: use of Medroxyprogesterone acetate tablet
Control Group: use of GnRH antagonist
Main outcome variables
number of oocytes retrieved
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191205045621N2
Registration date:2020-05-24, 1399/03/04
Registration timing:registered_while_recruiting
Last update:2020-05-24, 1399/03/04
Update count:0
Registration date
2020-05-24, 1399/03/04
Registrant information
Name
Shokufe Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2475
Email address
jafarish@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of oral Medroxyprogesterone acetate effect in the prevention of premature LH surge in IVF cycles in comparison with antagonist protocol
Public title
Effect of medroxyprogesterone acetate in the prevention of premature LH surge in IVF cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age under 42 years
regular menstrual cycles over the previous 3-month period
antral follicle count (AFC) of 7-24 on menstrual cycle day 2–3
Normal TSH and Prolactin levels
Exclusion criteria:
endometriosis grade 3 or higher
diagnosis of polycystic ovarian syndrome
presence of ovarian cyst
hormone treatment receipt within the previous 3-month period
low ovarian reserve (AMH<1.1 or AFC<7)
any contraindication to ovarian stimulation treatment
basal serum FSH concentration of more than 10 IU/L
Age
To 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: Patients will be recruited consecutively and allocated to one of the two groups in an alternating fashion. Odd-numbered participants will be allocated to the MPA group and even-numbered participants will be assigned to the Antagonist protocol.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be aware of the type of medication they receive and the second executor of the research project will collect primary data at the end of the treatment without knowledge of the two groups. Also the data will be analyzed without any information about group selection.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz university of Medical Science
Street address
Zand street- central building of Shiraz University of Medical Sciences-Shiraz
City
Shiraz
Province
Fars
Postal code
197871345
Approval date
2019-12-15, 1398/09/24
Ethics committee reference number
IR.SUMS.MED.REC.1398.513
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
number of oocytes retrieved
Timepoint
on day of oocyte retrieval
Method of measurement
count
Secondary outcomes
1
Description
number of mature oocytes
Timepoint
on day of oocyte retrieval
Method of measurement
count
2
Description
clinical pregnancy
Timepoint
3 weeks after IVF
Method of measurement
Measurement of beta-hCG
3
Description
Embryos number
Timepoint
after 24 hours and day 5
Method of measurement
microscopic evaluation
4
Description
fertilization rate
Timepoint
24 hours after intra-cytoplasmic sperm injection
Method of measurement
microscope
5
Description
implantation rate
Timepoint
2 weeks after embryo transfer
Method of measurement
Measurement of beta-hCG
Intervention groups
1
Description
Intervention group: the group will be administered hMG (150–225 IU) and MPA (10 mg/d) from MC3 onward
Category
Treatment - Drugs
2
Description
Control group: the group will be administered hMG (150–225 IU) and Triptorelin 0.1 mg SQ and 1500 IU hCG
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zeinabiyeh Hospital
Full name of responsible person
Mina Moosaie
Street address
Zeinabye Street
City
Shiraz
Province
Fars
Postal code
۷۱۵۳۸۱۳۳۱۱
Phone
+98 71 3726 6811
Email
zeinabhp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Yoones Ghasemi
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?