Luteal phase estradiol versus luteal phase GnRH antagonist administration: their effects on antral follicular size coordination and basal hormonal levels
The aim of this study is to compare the previous luteal phase administration of Estradiol and GnRH antagonist on follicular size coordination and hormones level in ICSI cycle, antagonist protocol. Thirty 20-35 years old women, with male factor infertility who are candidate for IVF with regular menstrual cycles and normal Body mass index (BMI) will be recruited. Exclusion criteria are those with history of hormone therapy for the past preceding 3 months or single ovary . All women, on 3th day of first cycle, undergo the transvaginal ultrasonography to measure the size and number of antral follicles. Serum level of FSH ,Inhibin and Estradiol will measure. Then they will allocate to two groups. In first group, from 20th day, estradiol tab 4 mg daily will administer until next 2nd day of cycle. In other group, single dose of GnRH antagonist (Amp cetrotide) will inject on 25th cycle day. In 3rd day of next cycle, sonography and level of serum hormone will be evaluated. Primary out comes are coordination of follicle size and hormone levels before and after the intervention.Exclusion criteria are those with history of hormone therapy for the past preceding 3 months or single ovary . In all women on day 3 of first cycle the transvaginal ultrasonography to measure the size and number of antral follicles is done and the serum level of FSH ,Inhibin and Estradiol is evaluated then they in luteal phase are randomized to two group ,in group 1 on cycle day 20 estradiol tab 4 mg daily orally is administered until cycle day 2 of next cycle and in group 2 GNRH antagonist Amp cetrotide single dose is infused on cycle day25 then in two group on cycle day 3 of next cycle the sonography and serum hormone evaluation is repeated such as day 3 of previous cycle .Primery out come are coordination of follicle size and hormone levels before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103052568N2
Registration date:2011-05-03, 1390/02/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-03, 1390/02/13
Registrant information
Name
Haleh Rahmanpour
Name of organization / entity
Zanjan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 241413003
Email address
haleh509@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Luteal phase estradiol versus luteal phase GnRH antagonist administration: their effects on antral follicular size coordination and basal hormonal levels
Public title
Comparison of two interventions on IVF outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : 20-35 years old , male factor infertility , candidate for IVF , regular menstrual cycles , normal Body mass index (BMI) .
Exclusion criteria :Those with history of hormone therapy for the past preceding 3 months , single ovary .
Age
From 20 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Tehran University of Medical Sciences
Street address
Keshavarz Blvd - Ghods street
City
Tehran
Postal code
Approval date
2008-04-20, 1387/02/01
Ethics committee reference number
798
Health conditions studied
1
Description of health condition studied
complications associated with artificial fertilization
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
size of antral follicles
Timepoint
20 days before intervention and 10 days after intervention
Method of measurement
transvaginal sonography
Secondary outcomes
1
Description
serum FSH
Timepoint
20 days before intervention and 10 days after intervention
Method of measurement
blood sample
2
Description
Serum inhibin
Timepoint
20 dayes before intervention and 10 dayes after intervention
Method of measurement
blood sample
3
Description
Serum Estradiol
Timepoint
20 days before intervention and 10 days after intervention
Method of measurement
Blood sample
Intervention groups
1
Description
In intervention group one GNRH antagonist ampule is infused subcutaneusly on 25th of first cycle .
Category
Treatment - Drugs
2
Description
in control group 4 mg Estradiol tab daily administered from 20th day of first cycle to 2nd day of second cycle.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Haleh Rahmanpour
Street address
Keshavarz Blvd,Emam Khomeini hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fedieh Haghollahi
Street address
Valiasr hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Thran University of Medical Sciences
Full name of responsible person
Haleh Rahmanpour
Position
Obestetric and Gynecologist
Other areas of specialty/work
Street address
Keshavarz Blvd,Ghods street
City
Tehran
Postal code
1419733141
Phone
+98 66939320
Fax
+98 66581658
Email
haleh509@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Batool Rashidi
Position
Obestetric and Gynecologist
Other areas of specialty/work
Street address
Valiasr hospital
City
Tehran
Postal code
1419733141
Phone
+98 21939320
Fax
+98 21 6658 1658
Email
bhrashidi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Haleh Rahmanpour
Position
Obestetric and Gynecologist
Other areas of specialty/work
Street address
Valiasr Hospital
City
Tehran
Postal code
1419733141
Phone
+98 21 6693 9320
Fax
+98 21 6658 1658
Email
haleh509@zums.ac.irhaleh509@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)