Efficacy of gonadotropin-releasing hormone agonist addition for luteal phase support in women with repeated implantation failure undergoing intracytoplasmic sperm injection cycles
For support of Luteal phase routinely we use progestron suppository or intramuscular route. GnRh agonist induces the increase of FSH and LH.There is no evidence to increase anomalies in fetus.In this trial research we are going to study the efficacy of single dose of 0.1 mg Decapeptile (6days after ovum pick up in women undergoing antagonist protocol cycle and history of two or more IVF (Invitro Fertilization) failure in Avecinna center. After excluding anatomical and thyroidal factors and hydrosalpinx in women under 42 years, there are two groups:A)administration of cyclogest supp. 400 mg/BID after ICSI B) administration ofcyclogest supp.400 mg/BID after ICSI and 0.1 mg Decapeptile 6 days after ovum pick up subcutaneously.Implantation rate,(conception rate per embryo transfer) CPR,ongoing pregnancy rate,abortion below 10 weeks,twin pregnancy, βHCG 14 days after embryo transfer will be evaluated.
Efficacy of gonadotropin-releasing hormone agonist addition for luteal phase support in women with repeated implantation failure undergoing intracytoplasmic sperm injection cycles
Public title
The effect of decapeptile on treatment of infertile women in ICSI(Intracytoplasmic Sperm Injection) cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: couples with two or more IVF Failure with good quality embryo transfer; women with antagonist cycle; women with at least one embryo for transfer; women under IVF wiht ones gamet and women under 42 years.
Exclusion criteria: cycles with preimplantation genetic diagnosis; women with anatomical uterine disorders or hydrosalpinx and women with thyroid disorders.
Age
To 42 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Reasearch center of Jahad-Avicenna
Street address
Velenjak-Shahid Beheshti univercity-Jahad of univercity
City
Tehran
Postal code
19615-1177
Approval date
2012-11-20, 1391/08/30
Ethics committee reference number
91/5214
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Pregnancy
Timepoint
Ten days, 3 weeks, 3 months and 5 months after
Method of measurement
HCG, sonography, follow up
Secondary outcomes
1
Description
abortion
Timepoint
every 3 months
Method of measurement
sonography-follow up
2
Description
Twin pregnancy
Timepoint
Vaginal ultrasonography in 6-8 weeks
Method of measurement
Number of gestational sacs
Intervention groups
1
Description
Six days after ovum pick up single dose of 0.1 mg Decapeptile-S.C (Intervention group)
Category
Treatment - Drugs
2
Description
There is no intervention in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility and recurrent pregnancy loss of Avecinna
Full name of responsible person
Mohammadzadeh Afsaneh M.D
Street address
Shariati-Yakhchal
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Reaserch center of Avicenna
Full name of responsible person
Akhondi.Mohammad Mehdi.PHD
Street address
Shahid Beheshti university
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reaserch center of Avicenna
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
Infertility and recurrent pregnancy loss center of Avecinna
Full name of responsible person
Simin.Zafardoust
Position
Obstetrics and Gynecologist-Fellowship of infertility
Other areas of specialty/work
Street address
Shariaty-Yakhchal
City
Tehran
Postal code
19419113194
Phone
+98 21 2264 4701
Fax
+98 22644754
Email
siminzafardoost@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Infertility and recurrent pregnancy loss center of Avecinna
Full name of responsible person
Zafardoust Simin M.D
Position
Fellowship of infertility
Other areas of specialty/work
Street address
Yakhchal-Shriati
City
Tehran
Postal code
19419113194
Phone
+98 21 2264 4701
Fax
+98 22644754
Email
siminzafardoost@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Reaserch center of Jahad university
Full name of responsible person
Dr Zafardoost Simin
Position
Obstetrics and gynecologist-fellowship in infertility