Protocol summary
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Study aim
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The effectiveness of using a low-dose hCG supplementation in comparison with a GnRH agonist in the late follicular phase.
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Design
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Intervention 2: Ovarian stimulation with human menopausal gonadotropin was started from day 2 of cycle. Ovarian response was monitored by serial vaginal sonographies and evaluation of serum E2 levels. Patients received hMG until the end of ovarian stimulation.
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Settings and conduct
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Women younger than 38 years old who scheduled for ART were randomly divided into two groups of either hCG or hMG. In this not-blinded, phase 2 clinical trial without control group, randomization was performed using random number table.
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Participants/Inclusion and exclusion criteria
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All women younger than 38 years old, with regular menstrual cycles ,BMI\30 kg/m2, normal uterus and ovaries in vaginal ultrasound and basal FSH\10 IU/L were included .
Women with severe endometriosis, polycystic ovary syndrome (PCOS), history of pelvic surgery, azoospermia and more than two in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle failures were excluded from the study.
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Intervention groups
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Intervention 1: Ovarian stimulation with human menopausal gonadotropin was started from day 2 of cycle. Ovarian response was monitored by serial vaginal sonographies and evaluation of serum E2 levels. The administration of hMG was discontinued when at least six follicles >12 mm were observed and E2 levels were higher than 600 pg/ml; hMG was replaced by 200 IU per day of hCG until final follicular maturation.
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Main outcome variables
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Chemical pregnancy
General information
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Reason for update
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Updating the trial regarding actual sample size, actual recruitment start and end dates
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201107286420N5
Registration date:
2011-09-01, 1390/06/10
Registration timing:
retrospective
Last update:
2021-04-10, 1400/01/21
Update count:
1
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Registration date
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2011-09-01, 1390/06/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Yazd research and clinical center for infertility
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Expected recruitment start date
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2009-03-01, 1387/12/11
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Expected recruitment end date
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2011-01-01, 1389/10/11
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Actual recruitment start date
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2009-03-01, 1387/12/11
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Actual recruitment end date
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2010-09-30, 1389/07/08
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Trial completion date
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2011-05-01, 1390/02/11
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Scientific title
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Efficacy of low-dose human chorionic gonadotropin in late follicular phase of controlled ovarian stimulation using GnRH agonist protocol among infertile women undergoing assisted reproductive technology
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Public title
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Comparison of two protocols for controlled ovarian stimulation in infertile women undergoing assisted reproductive technology
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age<38 years
Regular menstrual cycle (25-35 days)
BMI <30 kg/m 2
Normal uterus and ovaries in vaginal ultrasound
FSH<10IU/L
Exclusion criteria:
Severe endometriosis
Polycystic ovarian syndrome
History of pelvic surgery
Azoospermia
More than two IVF or ICSI cycle failures
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Age
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From 18 years old to 38 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
130
Actual sample size reached:
122
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this trial, infertile women who were scheduled for ART and met the inclusion criteria, informed about the research design and signed a written consent form for randomly assignment either to case or control groups. All women were randomly divided into two groups using simple, individual through random number table. All women were consecutively assigned into two groups based on randomized list.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2010-11-10, 1389/08/19
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Ethics committee reference number
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2310
Health conditions studied
1
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Description of health condition studied
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Infertility
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ICD-10 code
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N97
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ICD-10 code description
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Female infertility
Primary outcomes
1
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Description
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Chemical pregnancy
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Timepoint
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2 weeks
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Method of measurement
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BHCG serum
Secondary outcomes
1
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Description
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Clinical pregnancy
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Timepoint
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7 weeks after embryo transfer
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Method of measurement
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Sonography
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Deputy of Research and Technology, Yazd Shahid Sadoughi Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All participant data sets are to be shared
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When the data will become available and for how long
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2 months after the result publication
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To whom data/document is available
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A journal in which the results are published
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Under which criteria data/document could be used
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Submission of an official application via the agent that is legally in charge
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From where data/document is obtainable
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A journal in which the results are published
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What processes are involved for a request to access data/document
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Submission of an official application via the agent that is legally in charge
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Comments
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