Infertility Clinical Trial
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
Verified date | April 2019 |
Source | Kasr El Aini Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | October 31, 2018 |
Est. primary completion date | October 31, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 39 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | KasralainiH | Cairo |
Lead Sponsor | Collaborator |
---|---|
Kasr El Aini Hospital |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical pregnancy rate per cycle. | Detection of gestational sac , embryo pole and fetal pulsations by transvaginal ultrasound | 7 weeks | |
Secondary | number of oocytes retrieved per cycle. | number of oocytes retrieved during ovum pickup per cycle. | 3 weeks | |
Secondary | fertilization rate per cycle. | The number of oocytes fertilized by intracytoplasmic sperm injection per cycle. | 3weeks | |
Secondary | number of embryos per cycle. | number of embryos of any grade ( first, second, third or fourth grade) per cycle | 3weeks | |
Secondary | embryo quality per cycle. | embryo quality by grade ( first, second, third or fourth) per cycle. | 3weeks | |
Secondary | chemical pregnancy rate per cycle. | Positive beta hCG in serum per cycle. | 5 weeks | |
Secondary | twins rate per cycle. | Detection of 2 gestational sacs with positive fetal poles and pulsations per cycle. | 9 weeks | |
Secondary | miscarriage rate per cycle. | Early pregnancy loss per cycle. | 16 weeks |
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