Protocol summary
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Study aim
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The purpose of this study is to compare and compare pregnancy rates using progesterone prime protocol and antagonist protocol in patients with the polycystic ovarian syndrome who are the candidate for ART.
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Design
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The clinical trial with the randomized control group
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Settings and conduct
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Randomized clinical trial without blindness,
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: infertile PCOS patients which are the candidate for ART
Exclusion criteria: systemic disease; history of endocrine disorder; intrauterine abnormality (uterine polyp & submucosal fibroma & intrauterine adhesions); severe endometriosis; and azoospermia of partner.
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Intervention groups
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progesterone prime group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously and 20 mg dydrogesterone (Duphaston) orally. when dominant follicle reaches to 17 mm, final triggering will be done and 36 hours later. all embryo will be freez in cleavage stage and frozen embryo transfer will be done 2 months latter.
Antagonist group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously.vaginal sonography will be done for all women since 6th day of cycle. When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done and 36 hours later. all embryo will be freez in cleavage stage and frozen embryo transfer will be done 2 months later.
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Main outcome variables
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Clinical pregnancy rat
General information
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Reason for update
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Update corrections and study results
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110509006420N18
Registration date:
2018-08-20, 1397/05/29
Registration timing:
retrospective
Last update:
2021-06-28, 1400/04/07
Update count:
2
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Registration date
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2018-08-20, 1397/05/29
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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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2018-05-22, 1397/03/01
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Expected recruitment end date
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2018-06-22, 1397/04/01
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Actual recruitment start date
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2018-05-22, 1397/03/01
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Actual recruitment end date
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2018-06-24, 1397/04/03
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Trial completion date
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2019-01-07, 1397/10/17
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Scientific title
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progestin primed ovarian stimulation protocol in patients with the polycystic ovarian syndrome in assisted reproductive technology cycles
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Public title
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progestin primed ovarian stimulation protocol in the polycystic ovarian syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
infertile PCOS patients which are candidate for ART
Exclusion criteria:
women older than 40 years old
History of endocrine disorder
Severe endometriosis
Azoospermia
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Age
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From 18 years old to 40 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:
100
Actual sample size reached:
120
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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 done by sealed envelops.
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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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2018-05-20, 1397/02/30
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Ethics committee reference number
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IR.SSU.RSI.REC.1397.003
Health conditions studied
1
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Description of health condition studied
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Female infertility, unspecified
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ICD-10 code
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N97.9
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ICD-10 code description
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Female infertility, unspecified
Primary outcomes
1
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Description
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chemical pregnancy
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Timepoint
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Two weeks after embryo transfer
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Method of measurement
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Serum BhCG
2
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Description
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Clinical pregnancy
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Timepoint
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Two weeks after positive BhCG
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Method of measurement
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sonography
Secondary outcomes
1
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Description
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Miscarriage rate
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Timepoint
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Loss of pregnancy before 20 gestational week
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Method of measurement
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Absence of fetal heart activity in ultra sound sonography
Intervention groups
1
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Description
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Intervention group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously and 20 mg dydrogesterone (Duphaston) orally. when dominant follicle reaches to 17 mm,final triggering will be done by HCG (Pregnyl - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done.48 latter all embryo will be freeze in cleavage stage and frozen embryo transfer will be done 2 months latter after preparation of endometer by estrogen and progesterone.
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Category
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Treatment - Drugs
2
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Description
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Control group: Antagonist group: since second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done by HCG (Pregnyle - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done.48 latter all embryo will be freeze in cleavage stage and frozen embryo transfer will be done 2 months later after preparation of endometer by estrogen and progestrone
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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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Yazd 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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Due to the privacy of patients
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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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The study protocol, the statistical analysis map, the clinical study report will be available after the publishing of the article
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When the data will become available and for how long
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After publishing the article
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To whom data/document is available
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Researchers working in academic institutions
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Under which criteria data/document could be used
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use in the retrospective study
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From where data/document is obtainable
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Yazd research and clinical center for infertility
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What processes are involved for a request to access data/document
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Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, the request is referred to the research experts and then get the data.
سایر توضیحات
فا خالی
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Comments
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Trial results
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Please tick if results have been published
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Yes
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Summary result posting date
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2021-03-17, 1399/12/27
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Table of baseline comparison
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Participant flow diagram
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Table of variable outcomes' results
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Table of adverse events
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First publication date
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empty
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Abstract of published paper
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AbstractBackground: In vitro fertilization is an important therapy for women with the polycystic ovarian syndrome (PCOS). The use of new ways of improving clinical results is yet required. Objective: This study was aimed to investigate the efficacy of progesterone primed ovarian stimulation (PPOS) and compare with conventional antagonist protocol in PCOS.Materials and Methods:A total of 120 PCOS women who were candidates for assisted reproductive technology treatment were enrolled in this RCT and were placed into two groups, randomly (n = 60/each). The PPOS group received 20 mg/day Dydrogesterone orally since the second day of the cycle and the control group received antagonist protocol. The pregnancy outcomes including the chemical and clinical pregnancy, the miscarriage rate, and the percent of gestational sacs/transferred embryos were compared in two groups.Results:Number of MII oocyte, maturity rate, Number of 2 pronuclei (2PN) and serum estradiol levels on trigger day were statistically lower in PPOS group (p = 0.019, p =0.035, p = 0.032, p = 0.030), respectively. Serum LH level on trigger day in PPOSgroup was higher than antagonist group (p = 0.005). Although there wasn’t severe ovarian hyperstimulation syndrome in any participants, mild and moderate ovarian hyperstimulation syndrome was less in PPOS group (p = 0.001). Also, the chemical and clinical pregnancy rates were higher in the antagonist group, although it was not statistically significant (p = 0.136, p = 0.093 respectively).Conclusion: Our study demonstrates that PPOS does not improve the chemical and clinical pregnancy rate of infertile women with PCOS.