Effect of recombinant HCG administration in follicular phase on clinical pregnancy rate in frozen cycles of infertile women.(Tehran,Omid infertility center,2014-2015
Objectives: Assessment of recombinant HCG hormone in follicular phase on clinical fertility rate among freeze cycles of 250 infertile women of the study clinic.
Design: randomized clinical trial with parallel design with two arms (intervention and control groups)
Setting and conduct: All patients undergo long protocol cycle get contraceptive drugs and Folic Acid (five mg) from the third to 21th day of their cycle and then 0.5 mg Superfact (Sinafact) will be injected which will be continued up to the third day of the next period. According to Ultrasound study if the Endometrial thickness will less than three mm and without ovarian cyst, the amount of Superfact will be halved and one Estradiol tablet (two mg) for four days, two Estradiol Tablets (four mg) for next four days and then three Estradiol tablets after that (6mg) will be added. 125 units Recombinant HCG as trial intervention will inject for interventional group subcutaneously from 8th day of their period for seven days. In days 12th to 14th of the cycle, ultrasound will be done for all patients and if the thickness of Endometrium was between 8 to 14 mm, Progesterone Suppository (400u/bid) will prescribe and the Estradiol Tablets will be continued. After five days, the multicellular embryo (Blastocyst) will transfer. After two weeks if βHCG was positive two weeks later transvaginal ultrasound will be done, if FHR was detected estradiol will taper and progesterone suppository will continue until eight weeks. Clinical pregnancy among trial participants will determine as main outcome.
Eligibility criteria: infertile women who were candidate for in vitro fertilization cycles and recipient of frozen embryo will include and women with uterus fibroma, polyps bigger than two centimeters or Mullerian anomaly will exclude.
Intervention: Injection of 125 units Recombinant HCG subcutaneously from 8th day of their period for seven days.
Main outcome measures: clinical pregnancy rate according ultrasonography and fetal heart rate
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012020736N1
Registration date:2015-12-16, 1394/09/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-16, 1394/09/25
Registrant information
Name
Ashraf Alyasin
Name of organization / entity
Shariati hospital,Fertility center
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 8810
Email address
alyasina@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of recombinant HCG administration in follicular phase on clinical pregnancy rate in frozen cycles of infertile women.(Tehran,Omid infertility center,2014-2015
Public title
Effect of recombinant HCG administration in infertile women with IVF procedure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women who were IVF candidate;
infertile women who was recipient of Freezing embryo;
Exclusion criteria:
having uterus fibroma;
having polyps bigger than 2 cm;
Having Mullerian anomaly;
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
250
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Research Committee of Tehran University of Medical science
Street address
Medicine faculty, Poursina street, Tehran, Iran
City
Tehran
Postal code
1417613151
Approval date
2015-02-24, 1393/12/05
Ethics committee reference number
9111290027-129556
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Inability to achieve a pregnancy sterility
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
after four weekes
Method of measurement
B-HCG , miliunit
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
two weeks after intervention
Method of measurement
transvaginal ultrasound and FHR
Intervention groups
1
Description
for trial group|: 125 units Recombinant HCG
will be injected Subcutaneously from 8th day of their period for 7 days of mensuration period. Daily injection of 25 mg progesterone and daily usage of 800 milligrams progesterone suppository
Category
Treatment - Drugs
2
Description
Control group: Daily injection of projestron 25 mg and 800 milligrams progesterone suppository