Transfer of frozen embryos increases cumulative pregnancy rates and decreases costs. The aim of our study is to assess the advantage of HCG injection in secretory phase plus estrogen and progesterone to transfer cryopreserved-thawed embryos. 130 women are entered to this study after inform consent. All women have failed previous in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), and they have cryopreserved embryos transfer. Women with azospermia and severe endometriosis are excluded from this study. In case group, HCG is injected 5000 IU in the first day of progesterone injection and in the embryo transfer time. Primary outcome includes chemical pregnancy that is evaluated 2 weeks after embryo transfer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107266420N4
Registration date:2011-09-18, 1390/06/27
Registration timing:retrospective
Last update:
Update count:2
Registration date
2011-09-18, 1390/06/27
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid sadoughi university of medical sciences
Expected recruitment start date
2009-01-01, 1387/10/12
Expected recruitment end date
2011-01-01, 1389/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of human chorionic gonadotropin (HCG) addition during secretary phase in frozen-thawed embryo transfer cycles
Public title
Comparison of two protocols for transfer of the frozen embryos
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: History of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) fail; cryopreservation of excess embryos. Exclusion criteria: age >38 years; BMI>30; history of endocrine disorder; severe endometriosis.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
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 reserch and clinical center for infertility
Street address
Booali street
City
Yazd
Postal code
Approval date
2011-06-20, 1390/03/30
Ethics committee reference number
928
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N99
ICD-10 code description
Postprocedural disorders of genitourinary system, not elsewhere classified
Primary outcomes
1
Description
chemical pregnancy
Timepoint
2 weeks
Method of measurement
serum BHCG
Secondary outcomes
1
Description
clinical sonography
Timepoint
2 weeks
Method of measurement
sonography
Intervention groups
1
Description
Intervention: all women receive estradiol valerate 6 mg PO per day from the second day of menstrual cycle. Endometrial thickness is assessing by using vaginal ultrasonography since 13th day of cycle. Progesterone 100mg is injected when endomethrial thickness reaches to 8 mm. Estradiol and progesterone consumption are continued until 10th weeks of gestational age. HCG 5000 IU is injected in the first day of progesterone injection and in the day of embryo transfer.
Category
Treatment - Drugs
2
Description
Control: all women receive estradiol valerate 6 mg PO per day from the second day of menstrual cycle. Endometrial thickness is assessing by using vaginal ultrasonography since 13th day of cycle. Progesterone 100mg is injected when endomethrial thickness reaches to 8 mm. Estradiol and progesterone consumption are continued until 10th weeks of gestational age.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd reserch and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Street address
Bouali Avenue, Safayeh
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd reaserch and clinical center for infertility
Full name of responsible person
Dr.Abbas Aflatoonian
Street address
Bouali Avenue, Safayeh
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd reaserch 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 center for infertility
Full name of responsible person
Dr Maryam Eftekhar
Position
Assisted professor
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd reserarch and clinical center for infertility
Full name of responsible person
Dr Maryam Eftekhar
Position
Assisted professor
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr Maryam Eftekhar
Position
Assisted professor
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)