Comparison of pregnancy rate for the best method for endometrial preparation in natural and hormonal cycles for the transfer of freeze-thawed embryos in infertile patients
The purpose of this study is to compare the clinical pregnancy rates of Natural and Hormonal cycle in frozen embryo transfer. The study will be clinical trial, randomization, single center and double blind. 200 patients of Akbar Abadi hospital infertility unit who are planning an FET cycle, will join this study. Inclusion criteria will be regular ovulatory cycles; the ages will be between 19 to 45; causes of infertility will be male factor, endometriosis, tubal factor and idiopathic; basal serum levels of FSH will be less than or equal to 10 IU/I with normal Prolactin and absence of uterine anomalies. Patients with oocyte donation will be excluded from this survey. All patients who meet the inclusion criteria will be included after being informed of study condition and filling the inform consent form; then will be divided in two groups randomly. The first group will be those with Natural cycle and second group will be Hormonal cycle. Natural cycles with 100 infertile patients will be studied based on the daily serum LH of the 10th cycle day. When the serum LH level will be decreasing, ovulation will occur 36 to 40 hours later. The embryo transfer will be scheduled 3 to 5 days after ovulation. In hormonal cycles, 4 to 6 mg of Estradiol Valerate tablet will be taken from day 3 of the cycle. This group on 12th cycle day will undergo transvaginal sonography (TVS) for evaluation of endometrial thickness and if at least endometrial thickness 8 mm observed and embryos 3 to 5 days later will be transferred. The same day SUPP Progestrone 400 mg (Cyclogest) twice daily will be started. The embryo transfer will be scheduled 3 to 5 days after starting progesterone. Primary outcome is chemical pregnancy rate that will be measured by Beta-HCG testing for 14 days after the embryo transfer. Other outcomes will be clinical pregnancy and endometrial thickness.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081335670N1
Registration date:2017-10-08, 1396/07/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-08, 1396/07/16
Registrant information
Name
Fatemeh Ashtari
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 86701
Email address
javedanimasroor.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pregnancy rate for the best method for endometrial preparation in natural and hormonal cycles for the transfer of freeze-thawed embryos in infertile patients
Public title
Comparing the rate of pregnancy of Natural cycle and Hormonal cycle in frozen embryo transfer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: regular cycle; causes of infertility are male factor; endometriosis; tubal factor; idiopathic; serum levels of FSH is less than or equal to 10 IU/I; normal Prolactin; no allergy to Estradiol and Progesterone; the absence of uterine anomalies
Exclusion criteria: patients with oocyte donation will be excluded from this plan
Age
From 19 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is based on close envelope method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.IUMS.REC 1395.9211290001
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Chemical pregnancy rate
Timepoint
14 days after embryo transfer
Method of measurement
Beta-HCG using lab kit
Secondary outcomes
1
Description
clinical pregnancy rate
Timepoint
7 weeks after embryo transfer
Method of measurement
fetal heart rate in ultra sonography
2
Description
Endometrial thickness
Timepoint
From the 12th day of the cycle, one day in between
Method of measurement
Measurement with transvaginal ultrasound
Intervention groups
1
Description
Control group: Natural cycles with 100 infertile patients will be studied based on the daily serum LH of the 10th cycle day. When the serum LH level will be decreasing, ovulation will occur 36 to 40 hours later. The embryo transfer will be scheduled 3 to 5 days after ovulation
Category
Other
2
Description
Intervention group:. In hormonal cycles, 4 to 6 mg of Estradiol Valerate tablet will be taken from day 3 of the cycle. This group on 12th cycle day will undergo transvaginal sonography (TVS) for evaluation of endometrial thickness and if at least endometrial thickness 8 mm observed and embryos 3 to 5 days later will be transferred.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbar Abadi hospital
Full name of responsible person
Fatemeh Ashtari
Street address
Shahid Akbar Abadi hospital, Molavi st, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Kazem Malakouti
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
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 of Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Ashtari
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Shahid Akbar Abadi hospital, Molavi st, Tehran
City
Tehran
Postal code
Phone
+98 21 5560 6034
Fax
Email
el_ashtari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mojgan Javedani Masroor Tanha
Position
Assistant professor, Infertility Fellowship
Other areas of specialty/work
Street address
Shahid Akbar Abadi hospital, Molavi st, Tehran
City
Tehran
Postal code
Phone
+98 21 5560 6034
Fax
Email
javedanimasroor.m@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Ashtari
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Shahid Akbar Abadi hospital, Molavi st, Tehran
City
Tehran
Postal code
Phone
+98 21 5560 6034
Fax
Email
el_ashtari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)