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The Value of Prednisolone With Aspirin Before Embryo Transfer in Intracytoplasmic Sperm Injection (ICSI) Cycles

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ClinicalTrials.gov Identifier: NCT03503227
Recruitment Status : Completed
First Posted : April 19, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Amira S Dieb, Kasr El Aini Hospital

Brief Summary:
This study is a prospective, double-blind, randomized controlled trial . It includes 250 infertile patients scheduled for ICSI cycle. The patients will be randomly allocated into two equal groups; daily oral low dose Acetylsalicylic acid and group B patients will receive daily oral low dose Acetylsalicylic acid and Low dose prednisolone. All 250 participants undergo similar ICSI cycles. Primary outcome is clinical pregnancy rate per cycle. Secondary outcomes include number of oocytes retrieved, fertilization rate, number of embryos, embryo quality, chemical pregnancy rate, twins rate and miscarriage rate per cycle.

Condition or disease Intervention/treatment Phase
Infertility Drug: prednisolone Drug: Acetyl Salicylic acid Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: The Value of Addition of Prednisolone to Acetylsalicylic Acid Prior to Embryo Transfer in Patients With First ICSI Cycles: A Randomized Controlled Trial
Actual Study Start Date : April 23, 2018
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018


Arm Intervention/treatment
Active Comparator: Aspirin
Patients will receive daily oral low dose Acetylsalicylic acid (75 mg) starting day 20 of the previous cycle withGonadotrophin releasing hormone agonist (GnRH agonist)
Drug: Acetyl Salicylic acid
daily oral low dose Acetylsalicylic acid (75 mg) : Antiplatelet agent

Active Comparator: Aspirin and prednisolone
Patients will receive daily oral low dose Acetylsalicylic acid (75 mg) and Low dose prednisolone (10 mg/day) starting day 20 of the previous cycle withGonadotrophin releasing hormone agonist (GnRH agonist).
Drug: prednisolone
daily oral low dose prednisolone (10 mg/day) :a glucocorticoid

Drug: Acetyl Salicylic acid
daily oral low dose Acetylsalicylic acid (75 mg) : Antiplatelet agent




Primary Outcome Measures :
  1. clinical pregnancy rate per cycle. [ Time Frame: 7 weeks ]
    Detection of gestational sac , embryo pole and fetal pulsations by transvaginal ultrasound


Secondary Outcome Measures :
  1. number of oocytes retrieved per cycle. [ Time Frame: 3 weeks ]
    number of oocytes retrieved during ovum pickup per cycle.

  2. fertilization rate per cycle. [ Time Frame: 3weeks ]
    The number of oocytes fertilized by intracytoplasmic sperm injection per cycle.

  3. number of embryos per cycle. [ Time Frame: 3weeks ]
    number of embryos of any grade ( first, second, third or fourth grade) per cycle

  4. embryo quality per cycle. [ Time Frame: 3weeks ]
    embryo quality by grade ( first, second, third or fourth) per cycle.

  5. chemical pregnancy rate per cycle. [ Time Frame: 5 weeks ]
    Positive beta hCG in serum per cycle.

  6. twins rate per cycle. [ Time Frame: 9 weeks ]
    Detection of 2 gestational sacs with positive fetal poles and pulsations per cycle.

  7. miscarriage rate per cycle. [ Time Frame: 16 weeks ]
    Early pregnancy loss per cycle.



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women in reproductive age diagnosed with infertility for IVF/ICSI, female age (18- <40 years, normal serum hormonal profile on day 3 of the cycle [including estradiol (E2), FSH, LH, prolactin, thyroid stimulating hormone, normal uterine cavity diagnosed at hysteroscopy.

Exclusion Criteria:

  • Women with platelet dysfunction, thrombocytopenia, gastrointestinal ulcers, recurrent gastritis, Acetylsalicylic acid hypersensitivity, patients on corticosteroids will be excluded from the study.
  • Also women with known cause for recurrent miscarriage: antiphospholipid syndrome (positive anticardiolipin antibody or lupus anticoagulant on 2 separate occasions at least 6 weeks apart), thrombophilia (factor V Leiden mutation, activated protein C resistance (APCR) resistance, protein C or S deficiency, prothrombin gene mutation, antithrombin III deficiency), abnormal thyroid function tests, parental balanced translocation or uterine anomaly (known subseptate uterus or cervical weakness diagnosed at hysteroscopy).
  • Contraindications to steroid therapy: hypertension, diabetes, mental health problems or obesity with BMI >35
  • Decline consent to randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503227


Locations
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Egypt
KasralainiH
Cairo, Egypt, 11956
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Principal Investigator: Amira S Dieb, MD KasrAlainiH

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Responsible Party: Amira S Dieb, Ob/Gyn Lecturer, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03503227     History of Changes
Other Study ID Numbers: 1199012
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Infertility
Genital Diseases, Male
Genital Diseases, Female
Aspirin
Salicylates
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Salicylic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antipyretics
Glucocorticoids
Hormones