Objective: The impact of increased endometrial thickness with medroxyprogesterone acetate on pregnancy rate in the women with unexplained infertility or recurrent implantation failure. Design: before-after clinical trial. Setting and conduct: infertility clinics of Tabriz University؛ before intervention, blood tests such as serum progesterone concentration on day 21 of the menstrual cycle, FSH third day, AMH and testing Gravindex to ensure women in the study are not pregnant , as well as the transvaginal ultrasound to determine endometrial thickness were performed and will be recorded. the women will receive 5 mg oral Medroxyprogesterone acetate twice a day. then Gravindex test and transvaginal ultrasound are done to determine endometrial thickness. if the Gravindex test is positive, the drug will be gradually cut. If the test result is negative the drug to be completely cut off until menstruation occurs. Participants: women with unexplained infertility or recurrent implantation failure (RIF). Inclusion criteria: women aged 20-40؛ willingness to participate in the study؛ lack of pregnancy in inclusion time؛ endometrial thickness less than 8 millimeter by trans vaginal ultrasound؛ minimum of 1 year unexplained infertility history or more than 3 times of recurrent implantation failure؛ normal semen analysis according to WHO criteria. Exclusion criteria: willingness to use assisted reproductive technology؛ use of hormones in 1 month ago؛ polycystic ovarian syndrome. Sample size: 23 persons. Intervention: the women will receive 5 mg oral Medroxyprogesterone acetate twice a day from the 16th day of menstruation for 20 days. Main outcome: endometrial thickness؛ pregnancy rate؛ relationship between endometrial thickness and pregnancy rate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020227311N3
Registration date:2017-04-04, 1396/01/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-04, 1396/01/15
Registrant information
Name
Behnaz Sadeghzadeh Oskouei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 0364
Email address
sadeghzadehb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2017-03-19, 1395/12/29
Expected recruitment end date
2017-04-18, 1396/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect endometrial thickening with Medroxyprogesterone Acetate on pregnancy rate in the women with recurrent implantation failure
Public title
The effect endometrial thickening with Medroxyprogesterone Acetate on pregnancy rate in the women with recurrent implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
women aged 20-40؛
willingness to participate in the study؛
lack of pregnancy in inclusion time؛
endometrial thickness less than 8 milimeter by trans vaginal ultrasound؛
minimum 1 year unexplained infertility history or more than 3 times of repeated failure of implantation ؛
normal semen analysis according to WHO criteria.
Exclusion criteria:
willingness to use assisted reproductive technology؛
use of hormones in 1 month ago؛
debilitating disease of the ovary such as polycystic ovarian syndrome.
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
23
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz Univercity of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue,
City
Tabriz
Postal code
Approval date
2017-01-09, 1395/10/20
Ethics committee reference number
IR.TBZMED.REC.1395.1062
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.2
ICD-10 code description
Female infertility of uterine origin, Nonimplantation of ovum
Primary outcomes
1
Description
endometrial thickness
Timepoint
Before intervention and after intervention
Method of measurement
Transvaginal ultrasound
2
Description
Pregnancy rate
Timepoint
After interventin
Method of measurement
Gravindex test and transvaginal ultrasound
3
Description
Relationship between endometrial thickness and pregnancy rate
Timepoint
Before and after intervention
Method of measurement
Gravindex test and transvaginal ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
5 mg oral Medroxyprogesterone acetate twice a day for twenty days from 16th day of menstruation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
AlzahraTherapeutic Educational Center
Full name of responsible person
Dr. Behnaz Sadeghzadeh Oskuei
Street address
Baghshmal Intersection, South Army Street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Behnaz Sadeghzadeh Oskuei
Position
Assistante Professor, PhD Biology of Reproductive Medicine
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
sadeghzadehb@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Behnaz Sadeghzadeh Oskuei
Position
Assistante Professor, PhD Biology of Reproductive Medicine
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
sadeghzadehb@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Behnaz Sadeghzadeh Oskuei
Position
Assistante Professor, PhD Biology of Reproductive Medicine
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
sadeghzadehb@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)