The purpose of this study is to compare the clinical pregnancy rate of Natural and modified –natural cycle in frozen embryo transfer. This study is clinical trial, randomization, single center and double blind. Among Women will admitted to fertility unit of Arash hospital for planning an FET cycle, 140 will participated in this study. Age <38 years and regular ovulatory cycles are inclusion criteria. Exclusion criteria are PCOD and endometriosis. patients are divided two equal number.Group1: 70 patients with progestron pessary administration after positive urinary LH kit. Group 2: 70 patients with 5000 IU HCG injection IM state, after presenting endometrial thickness>7 mm and 17 mm dominant folicule in transvaginal sonography. After two weeks of FET procedure measurement of serum B-HCG will be carried out.
If the result of lab test was positive ?(B-HCG>10)clinical pregnancy, implantation, abortion rate will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607311556N92
Registration date:2016-08-24, 1395/06/03
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-08-24, 1395/06/03
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the rate of pregnancy of Natural versus modified –natural cycle for endometrial preparation in frozen embryo transfer
Public title
Comparing the rate of pregnancy of Natural versus modified –natural cycle in frozen embryo transfer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Regular menstrual cycle, Normal BMI, the previous history of up to two IVF cycle
Exclusion criteria: PCOD, history of endometriosis ( grade ≥3) according to AFS, abnormal uterin, FSH ≥12, Sever male factor
Age
To 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tehran University of Medical Sciences
Street address
Qods street
City
Tehran
Postal code
Approval date
2016-08-09, 1395/05/19
Ethics committee reference number
IR.TUMS.MEDICINE.RBC.1395.426
Health conditions studied
1
Description of health condition studied
In vitro fertilization
ICD-10 code
Z31.2
ICD-10 code description
In vitro fertilization
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
6 weeks of pregnancy
Method of measurement
Ultrasonography
2
Description
Abortion rate
Timepoint
During 20 weeks of pregnancy
Method of measurement
Ulthrasonography, B-HCG
Secondary outcomes
1
Description
Implantation
Timepoint
Gestational sac in 5 weeks of pregnancy
Method of measurement
ultrasonography
Intervention groups
1
Description
The control group(1): progestron pessary administration after positive urinary LH kit
Category
Treatment - Drugs
2
Description
5000 Iu HCG injection IM state, after presenting endometrial thickness>7 mm and 17 mm dominant follicule in trans-vaginal ultrasonography