Efficacy of low-dose human chorionic gonadotropin in late follicular phase in controlled ovarian stimulation in GnRH agonist protocol in infertile women undergoing assisted reproductive technology
This prospective study evaluates the effect of low dose human chorionic gonadotropin injection in late follicular phase instead of gonadotropins administration in agonist long protocol. This randomized controlled trial includes 122 patients, who are going to have assisted reproductive technology treatment. Patients are randomly divided into two groups. Their ages are less than 38 years old with regular menstrual cycle (25-35 days) and BMI less than 30 kg/m 2. Exclusion criteria are severe endometriosis, PCOS, history of pelvic surgery and azoospermia. The control group receive standard long protocol. The study group (n=60) receive GnRH long protocol. They receive 200 IU HCG instead of HMG when they have more than 6 follicles with mean diameter more than 12 mm. Primary outcome is chemical pregnancy, which is defined by positive beta–hCG 12 days after embryos transfer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107286420N5
Registration date:2011-09-01, 1390/06/10
Registration timing:retrospective
Last update:
Update count:1
Registration date
2011-09-01, 1390/06/10
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
Yazd research and clinical center for infertility
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
Efficacy of low-dose human chorionic gonadotropin in late follicular phase in controlled ovarian stimulation in GnRH agonist protocol in infertile women undergoing assisted reproductive technology
Public title
Comparison of two protocols for controlled ovarian stimulation in infertile women undergoing assisted reproductive technology
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age<38 years; regular menstrual cycle (25-35 days); BMI <30 kg/m 2; normal uterus and ovaries in vaginal ultrasound and basal FSH<10IU/L. Exclusion criteria: severe endometriosis; PCOS; history of pelvic surgery; azoospermia and more than two IVF or ICSI cycle failures.
Age
From 18 years old to 38 years old
Gender
Female
Phase
2-3
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 Research and Clinical Center for Infertility
Street address
Bouali Ave, Safayeh
City
Yazd
Postal code
8916877391
Approval date
2010-11-10, 1389/08/19
Ethics committee reference number
2310
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
chemical pregnancy
Timepoint
2 weeks
Method of measurement
BHCG serum
Secondary outcomes
1
Description
clinical pregnancy
Timepoint
2week
Method of measurement
sonography
Intervention groups
1
Description
The control group (n=62) receive standard long protocol and gonadotropins administration continue until the day of hCG injection (10000 IU) for final follicular maturation.
Category
Treatment - Drugs
2
Description
The study group (n=60) receive GnRH long protocol. They receive 200 IU HCG instead of HMG when they have more than 6 follicles with mean diameter more than 12 mm.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd reserch and clinical center for infertility
Full name of responsible person
Dr Maryam Eftekhar
Street address
Boali street, Safaieh
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Clinical Center for Infertility
Full name of responsible person
Dr. Abbas Aflatoonain
Street address
Bouali Ave, Safayeh
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research 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
Research and Clinical Center for Infertility
Full name of responsible person
Dr Maryam Eftekhar
Position
Assisted professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Bouali Ave, 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 Research and Clinical Center for infertility
Full name of responsible person
Dr Maryam Eftekhar
Position
Assisted professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Re Bouali Ave, Safayeh
City
Yazd
Postal code
Phone
+98 913 156 3078
Fax
Email
eftekhar@ssu.ac.ireftekharmaryam@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd reaserch and clinical center for infertility
Full name of responsible person
Dr Maryam Eftekhar
Position
Assisted professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Research and Clinical Center for Infertility, Bouali Ave, Safayeh
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 8348
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)