a randomized clinical trial to compare the effect of bromocriptine-rebound method on ongoing pregnancy and live birth after Intracytoplasmic sperm injection cycles with long protocol
Objectives: To assess whether Bromocriptine rebound method (BR) can improve pregnancy outcomes after ICSI cycles.
Study design: prospective randomized clinical trial
Method : 114 patients of infertility center of Shariati hospital since 2009-2010
Inclusion : Ovulatory women with normal serum prolactin and endocrine profile who are younger than 40
Exclusion : severe male factor based on WHO citeria
The patients was randomly enrolled in two BR and Long protocol groups .BR method is similar to long protocol except administration of Bromocriptine 2.5 mg per day since day 4 of follicular phase till e7 days before gonadotropin stimulation .
Primary outcome : The rate of fertilized oocytes
secondary outcomes : ongoing pregnancy and live birth rates
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105016345N1
Registration date:2011-06-22, 1390/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-22, 1390/04/01
Registrant information
Name
Ramak Esmaeeli Azad
Name of organization / entity
Tehran University of Medical Science, Shariati hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 8810
Email address
esmaeiliazad@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
a randomized clinical trial to compare the effect of bromocriptine-rebound method on ongoing pregnancy and live birth after Intracytoplasmic sperm injection cycles with long protocol
Public title
The effect of Bromocriptine rebound method on Intracytoplasmic sperm injection cycles outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : normal endocrine pattern ; age younger than 40 yr ; normal basic serum prolactine concentrations ; ovulatory cycles ;
Exclusion criteria : severe male factor as a cause of infertility according to the WHO criteria
Age
To 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
114
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
Ethics committee of Tehran University of Medical Science
Street address
Shariati Educational , Research and Healthcare Center , the beginning of Jalal Al Ahmad High way , Karegar Ave, Keshavarz BLV, Tehran, Iran
City
Tehran
Postal code
Approval date
2011-05-02, 1390/02/12
Ethics committee reference number
210/1141/ص/90
Health conditions studied
1
Description of health condition studied
IVF/ICSI
ICD-10 code
Z31.2
ICD-10 code description
In vitro fertilization
Primary outcomes
1
Description
fertilized oocyte
Timepoint
1 months after intervention
Method of measurement
embryology labratory
Secondary outcomes
1
Description
ongoing pregnancy & Live birth
Timepoint
16 weeks & 37 weeks
Method of measurement
prenatal visits
Intervention groups
1
Description
intervention : similar to long protocol except administration of Bromocriptine 2.5 mg per day since day 4 of follicular phase till 7 days before gonadotropine syimulation
Category
Treatment - Drugs
2
Description
control : long protocol
In preceding cycle, OCP was administered from day 3 for a month and Buserelin (Superfact, Aventis, Frankfurt, Germany) was started 0.5 mg daily from day 21. Then, ovarian hyper stimulation was initiated with recombinant FSH (Gonal F, Serono, and Aubnne, Switzerland) in different doses according to ovarian antral follicle count in sonography on day 2 of withdrawal bleeding. Serial ultrasound examinations were used to assess ovarian response, and then gonadotropin dose adjustments were done as required. Human chorionic gonadotropin (Pregnyl, Organon, Oss, the Netherlands) 10,000 IU was administered when at least two follicles reached a mean diameter of 18 mm. Oocytes retrieval was performed 36 hours after hCG administration and oocytes were inseminated with ICSI. Evidence for fertilization was assessed approximately 18 h after insemination. Embryo transfer was performed on day 2. Luteal support with progesterone in oil (Progesterone, Aburaihan Co., Tehran, Iran) 25 mg daily IM and vaginal suppository Cyclogest was started on the day of oocytes retrieval and continued until the documentation of fetal heart activity on ultrasound. Chemical pregnancy was assessed based on Beta HCG after 14-15 days . 6 weeks later clinical pregnancy was documented based on presence of intra uterine gestational sac in trans vaginal sonography and ongoing pregnancy was determined if normal pregnancy last for more than 16 weeks .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital ; Tehran university of medicine
Full name of responsible person
Ramak Esmaeeli Azad
Street address
the beginning of Jalal Al Ahmad High way , Karegar Ave, Keshavarz BLV
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh ( professor )
Street address
Tehran University of Medical Siences school of medicine, Pursina st. , Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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
Tehran University of Medical Science
Full name of responsible person
Ramak Esmaeeli Azad
Position
Resident of OB & Gyn.
Other areas of specialty/work
Street address
the beginning of Jalal Al Ahmad High way , Karegar Ave, Keshavarz BLV
City
Tehran
Postal code
Phone
+98 21 8800 0085
Fax
Email
ramak.esmaeiliazad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Ramak Esmaeeli Azad
Position
resident of OB & Gyn
Other areas of specialty/work
Street address
the beginning of Jalal Al Ahmad High way , Karegar Ave, Keshavarz BLV
City
Tehran
Postal code
Phone
+98 21 8800 8810
Fax
Email
esmaeiliazad@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ramak Esmaeeli Azad
Full name of responsible person
Ramak Esmaeeli Azad
Position
Other areas of specialty/work
Street address
Shariati Hospital,the beginning of Jalal Al Ahmad High way , Karegar Ave, Keshavarz BLV
City
Tehran
Postal code
Phone
+98 21 8800 8810
Fax
+98 21 8822 0050
Email
esmaeiliazad@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)