Sildenafil Citrate in Early Unexplained Recurrent Pregnancy Loss (NCT03766594) | Clinical Trial Compass
CompletedPhase 1
Sildenafil Citrate in Early Unexplained Recurrent Pregnancy Loss
Egypt90 participantsStarted 2018-01-01
Plain-language summary
Recurrent unexplained spontaneous miscarriage (RSM) is defined as three consecutive pregnancy loss prior to 20 weeks from the last menstrual period. 1% to 2% of women experience RSM. Treatment of URSM is a challenging issue. The currently available lines of treatment according to simplicity of use, reliability and degree of invasiveness include corticosteroids, sildenafil citrate, aspirin, heparin and immunoglobulins (besides good antenatal care), but up to now there are no prospective randomized studies, powerful enough, to determine a significant difference between these therapeutic protocols, with any of the above mentioned pharmacological agents.
Sildenafil Citrate (Viagra®), a vasodilator, is also described as an anti-inflammatory agent. While improving uterine blood flow in the proliferative phase, NO may have detrimental effects at the level of the endometrium during the implantation window. The NO- mediated release of cytokines such as tumour necrosis factor- from activated natural killer cells has been implicated as a cause of implantation failure.
Based on these observations, this study attempts was made to study uterine arteries and sub-endometrial blood flow during the luteal phase in normal fertile women and in patients with Unexplained recurrent miscarriage
Who can participate
Age range
20 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 20-35 years.
* BMI (20-30)
* History of three or more successive unexplained recurrent miscarriage.
* Normal uterine cavity by hystrography or hysteroscopy.
* No luteal phase defects by progesterone \> 10 ng.
* Normal thyroid function (TSH, T3, T4)
* Normal lupus anticoagulant measured by activated partial throbmoplastine time (32-43 seconds).
* Normal anticardolipin (IgG \< 20 gpl and IgM \< 15 MPL measured by ELISA).
* Normal anti thyroid antibodies.
* Normal glucouse tolerance test.
* Normal parental karyotyping.
Exclusion Criteria:
* Age\<20 or\>35 year
* BMI\<20 or\>30
* Systemic diseases that might affect pregnancy such as diabetes or thyroid disorders or hypertension.
* History of consanguinity.
* Family history of chromosomal abnormalities (e.g. trisomy 21, trisomy 13, Turner's disease …etc.).
* History of autoimmune diseases, eg: systemic lupus.
* Congenital anomaly in uterine cavity as bicornate or septate uterus.
* Luteal phase defect and corpus luteum insufficiency.
* Uterine masses as fibroid or polyps.
* Patient with patuoles os.
* patient with antiphosphlipid syndrome.
* Cigarette smoking and alcohol.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.