Protocol summary
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Study aim
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Review and comparison the success rate, using Medroxyprogesterone acetate instead of GNRH antagonist in patients undergoing ICSI by using oocyte donation
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Design
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Clinical trial with control group, with parallel groups, single- blind, randomized
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Settings and conduct
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All infertile patients with oocyte donation undergoing ICSI, they are referred to private infertility clinic of Rasht, which are selected according to inclusion criteria. After giving explanations to individual, they are randomly divided.
Intervention groups are aware of how to intervene.To intervene to participants Medroxyprogesterone acetate is prescribed and Fertility success will be measured through transvaginal ultrasound and fetal heart rate monitoring.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: all infertile patients with oocyte donation undergoing ICSI.
Exclusion criteria: all patients are in case of side effects of the drug or lack of regular use of the drug.
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Intervention groups
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Intervention group: all infertile patients with oocyte donation under ICSI, which received 2 tablets of Medroxyprogesterone from the first day of the visit until the injection of HCG. The control group will receive the usual treatment.
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Main outcome variables
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Fertility success
General information
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Reason for update
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Due to achieving sufficient sample size
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20081007001306N10
Registration date:
2019-07-31, 1398/05/09
Registration timing:
prospective
Last update:
2021-03-21, 1400/01/01
Update count:
1
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Registration date
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2019-07-31, 1398/05/09
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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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Expected recruitment start date
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2019-08-23, 1398/06/01
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Expected recruitment end date
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2020-05-21, 1399/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Review and comparison the success rate, using medroxy progesterone acetate instead of GNRH antagonis, in patients undergoing intracytoplasmic sperm injection (ICSI) by using oocyte donation, single-blind clinical trial
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Public title
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Review and comparison the success rate, using medroxy progesterone acetate instead of GNRH antagonist,in patients undergoing intracytoplasmic sperm injection (ICSI) by using oocyte donation
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
All infertile patients with oocyte donation undergoing ICSI
Exclusion criteria:
In the oocyte donor:Age over 35 years, irregular menstruation, antral follicle count less than 5 and more than 12, FSH more than 10 on the third day of menstruation, cystic ovaries and endometriosis, BMI greater than 25, not having at least one child and the presence of any disease affecting ovulation (such as thyroid disease and high prolactin levels)
In the oocyte receptor: Age over 50 years , any systemic disease including hypertension, diabetes, chronic diseases, liver and kidney, problem in the uterus and tubes (including: leiomyoma, polyp, adenomyosis, ashren and hydrosalpinx and etc.) and there is male factor
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Age
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From 20 years old to 50 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
216
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be generated by Random Allocation software, each of which is placed in a separate package according to the software list and closed it and gave it to a third person . In case of referral of the patient and his eligibility,the envelope is opened and It is treated based on the desired sequence without notice of the next treatment.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Analyst will be unaware of the type of intervention.
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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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2019-06-26, 1398/04/05
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Ethics committee reference number
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IR.GUMS.REC.1398.148
Health conditions studied
1
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Description of health condition studied
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Infertility in female
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ICD-10 code
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N97.0
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ICD-10 code description
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Female infertility associated with anovulation
Primary outcomes
1
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Description
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Fertility success
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Timepoint
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Two weeks after fetal transfer
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Method of measurement
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Pregnancy test
Secondary outcomes
1
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Description
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Seeing fetal heart rate
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Timepoint
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6 weeks after fetal transfer
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Method of measurement
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Vaginal ultrasound
Intervention groups
1
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Description
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Intervention group: prescription two tablets of Medroxyprogesterone containing 5 mg; manufactured by Abouryan company; Iran; from the first day of the visit until receiving HCG
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Category
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Treatment - Drugs
2
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Description
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Control group: Receive routine treatment
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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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Research vice-chancellorship, Guilan University of 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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The release plan is still unknown
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available