Protocol summary
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Study aim
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Determining the effect of progesterone as a trigger of ovulation gonadotropins
- Determining the effect of progesterone as an ovulation trigger in IVF/IUI cycles
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Design
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Clinical trial with parallel groups, without blinding, phase 3 on 36 patients, in two groups of IUI and IVF
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Settings and conduct
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This study will be conducted as a clinical trial. The studied sample will be selected from among the patients referred to Ibn Sina Infertility Treatment Center for IUI and egg donation who have the necessary criteria to enter the study, 18 people will be selected in each IUI, IVF group. The intervention will start with the injection of progesterone at a dose of 20 mg (the main recommended dose) as an ovulation trigger. The intermediate analysis will be done after the evaluation of the 9th volunteer, and if Lh surge fails in more than 5 people, sampling will be stopped.
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Participants/Inclusion and exclusion criteria
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1. Patient age 20-35 years
2. Normal hysterosalpingography in IUI group patients
3. normal vaginal ultrasound
4. Thyroid, prolactin, sugar and normal CBC tests
5. AMH above 2 ng/ml
6. Absence of diagnosed genetic or autoimmune disease
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Intervention groups
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Patients referred for IUI and egg donation who have the necessary criteria to enter the study will be placed in two groups, IU and IVF.
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Main outcome variables
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Primary Outcome Study of LH Surge Occurrence
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240506061667N1
Registration date:
2024-05-18, 1403/02/29
Registration timing:
prospective
Last update:
2024-05-25, 1403/03/05
Update count:
1
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Registration date
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2024-05-18, 1403/02/29
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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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2024-06-04, 1403/03/15
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Expected recruitment end date
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2024-08-05, 1403/05/15
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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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The role of progesterone as an ovulation trigger in IVF and IUI cycles, a clinical trial
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Public title
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The role of progesterone in ovulation
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
1. Patient age 20-35 years 2. Hysterosalpingography is normal in IUI group patients 3. Vaginal ultrasound is normal 4. Thyroid, prolactin, sugar and CBC tests are normal 5. AMH above 2 6. Genetic or autoimmune disease has been diagnosed
Exclusion criteria:
1. egg donation clients whose IVF cycle is canceled due to lack of suitable follicles (10-15) 2. history of ovarian cyst and endometriosis 3. patient unwillingness 4. immune and rheumatic disease 5. sensitivity to progesterone
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Age
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From 20 years old to 35 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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No information
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Sample size
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Target sample size:
36
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Randomization (investigator's opinion)
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N/A
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Randomization description
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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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2024-04-23, 1403/02/04
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Ethics committee reference number
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IR.ACECR.AVICENNA.REC.1403.003
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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N97.0
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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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Primary Outcome Study of LH Surge Occurrence
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Timepoint
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It is at 12 and 36 hours after injection
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Method of measurement
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In the ultrasound before the intervention, as well as the serum level of FSH, progesterone and estrogen at 12 and 36 hours after the injection.
Secondary outcomes
1
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Description
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The secondary outcome is the total number of eggs obtained
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Timepoint
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It is at 12 and 36 hours after injection
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Method of measurement
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In the ultrasound before the intervention, as well as the serum level of FSH, progesterone and estrogen at 12 and 36 hours after the injection.
Intervention groups
1
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Description
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Intervention group A: 18 people will be selected in the IVF group among the patients referred to Ibn Sina infertility treatment center for egg donation who have the necessary criteria to enter the study. In this study, egg donation patients undergo IVF cycle with antagonist protocol. The intervention will start with the injection of progesterone with a dose of 20 mg as an ovulation trigger
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Category
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Treatment - Drugs
2
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Description
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Intervention group B: Intervention group: 18 people in each IUI group will be selected from the patients referred to Ibn Sina Infertility Treatment Center for IUI who have the necessary criteria to enter the study. In this study, in IUI patients, GNRH antagonist is started when the follicle is 14 mm. The intervention will start with the injection of progesterone with a dose of 20 mg as an ovulation trigger.
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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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Iranian academic center for education culture and research
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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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Private
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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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Other
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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Data related to non-identifiable personal information of individuals will be accessible if needed
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When the data will become available and for how long
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Immediately after the publication of the article, if necessary, non-identifiable data will be provided
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To whom data/document is available
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The data will be available to all researchers in scientific and academic centers
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Under which criteria data/document could be used
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De-identified patient data will be available upon request by researchers
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From where data/document is obtainable
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The e-mail of the project managers is available to request information and data of the project
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What processes are involved for a request to access data/document
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The request is sent through the e-mail of the organizers of the project
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Comments
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