Progesterone is a prerequisite for development of the endometrium and implantation of an embryo. Low levels of progesterone during early pregnancy may result in miscarriage. The study is designed as a prospective randomized clinical trial.100 patients undergoing frozen embryo transfer in natural cycle in Yazd research and clinical center for infertility between March 2011 to March 2012.Inclusion criteria: regular menstrual cycle, 20<age<40.Exclusion criteria: egg donation, endometriosis. All patients undergo transvaginal ultrasound on day 10 of cycle and are repeated as needed. When endometrial thickness >8mm and a follicle 18mm are present on ultrasound, 10000 IU HCG is injected IM and in the day of hCG administration serum estradiol is assessed. Randomly, 50 patients as interventional group receive 100mg/day progesterone IM starting from 36 hour after HCG administration and continue until 10 weeks of gestation if pregnancy is occurred. Control group (50patients) is not received progesterone. In both groups cryopreserved embryo transfer is considered 5 days after the HCG administration. Clinical pregnancy and implantation rate is compared between two groups. (Implantation rate defined as the number of gestational sac observed by ultrasound at 4 weeks after embryo transfer per 100 embryos transferred).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108044339N6
Registration date:2011-09-22, 1390/06/31
Registration timing:registered_while_recruiting
Last update:
Update count:2
Registration date
2011-09-22, 1390/06/31
Registrant information
Name
Elham Rahmani
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77125265914
Email address
rahmani@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd research and clinical center for infertility
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of progesterone in natural frozen – thawed embryo transfer cycles
Public title
natural frozen – thawed embryo transfer cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: regular menstrual cycle, aged between 20 and 40, the patient had at least 3 frozen embryo. Exclusion criteria: egg donation, endometriosis, poly cystic ovarian syndrome.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd research and clinical center for infertility
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Postal code
8916877391
Approval date
2011-06-20, 1390/03/30
Ethics committee reference number
929
Health conditions studied
1
Description of health condition studied
female infertility
ICD-10 code
N97
ICD-10 code description
female infertility
Primary outcomes
1
Description
chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
BHCG TEST
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
5 weeks after embryo transfer
Method of measurement
Obestetrics sonography
Intervention groups
1
Description
In interventional group (50 patients) patients undergo transvaginal ultrasound on day 10 of cycle and are repeated as needed. When endometrial thickness >8mm and a follicle 18mm are present on ultrasound, 10000 IU HCG is injected and In the day HCG administration serum estradiol is assessed.36 hour after HCG administration patients receive 100mg/day progesterone IM and continue until 10 weeks of gestation if pregnancy is occurred. The cryopreserved embryo transfer is considered 5 days after the HCG administration.
Category
Treatment - Drugs
2
Description
In control group (50 patients) patients undergo transvaginal ultrasound on day 10 of cycle and are repeated as needed. When endometrial thickness >8mm and a follicle 18mm are present on ultrasound, 10000 IU HCG is injected and in the day HCG administration serum estradiol is assessed. Control group is not received progesterone .The cryopreserved embryo transfer is considered 5 days after the HCG administration
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd research and clinical center for infertility
Full name of responsible person
Dr Maryam Eftekhar
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr Maryam Eftekhar
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd research and clinical center for infertility
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
Yazd research and clinical center for infertility
Full name of responsible person
Dr Mozhgan Rahsepar
Position
Obestetrics and Gynecologist,Student of fellowship
Other areas of specialty/work
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
drrahsepar@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr Maryam Eftekhar
Position
Obestetrics and Gynecologist, fellowship of infertility
Other areas of specialty/work
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
eftekharmaryam@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)