UnknownPhase 1

Endometrial Effects of Sildenafil in Frozen-Thawed Cycles in Women With Thin Endometrium

Egypt100 participantsStarted 2021-09-01

Plain-language summary

Management of Thin endometrium in IVF is challenging. Thin endometrium is often defined as \<7 mm or \< 8 mm on the day of Human Gonadotropin administration(Bu and Sun, 2015; Wu et al., 2014). Its incidence is 1-2.5% in most studies ( AlGhamdi et al.,2008). Endometrial thickness and endometrial vascularity is closely linked to endometrial receptivity.Improving endometrial receptivity is a predictor of the success in IVF. Many medications have been tried to improve endometrial thickness as Aspirin,sildenafil citrate,luteal estradiol and Granulocyte colony stimulating factor. Nitric oxide (NO) is a key signaling molecule involved in the vasodilator response of smooth muscle cells. NO activates the cyclic guanosine monophosphate (cGMP)/protein kinase G (PKG) pathway within smooth muscle cells to promote smooth muscle cell relaxation. Sildenafil citrate inhibits phosphodiesterase 5 (PDE5) maintaining activation of cGMP and PKG and maximizing the effect of existing NO, thus facilitating smooth muscle cell relaxation. The potent vasodilator action of sildenafil has led researchers to evaluate sildenafil as a treatment in assisted reproduction where low uterine blood flow is perceived to be a contributor to implantation failure (Fairouzabadi et al.2013). The investigators aim at this study to investigate the role of sildenafil citrate on endometrial and subendometrial vasculature in women with thin endometrium undergoing Frozen-Thawed IVF cycles.

Who can participate

Age range

25 Years – 40 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: * Women (25 -40 years) undergoing IVF frozen-Thawed cycles and known to have good quality embryos. * previous thin endometrium (\< 8mm on at least 3 previous cycles) with normal Hysteroscopy findings Exclusion Criteria: * women less than 25 years old or more than 40 years old. * abnormal hysteroscopic findings. * women with congenital uterine anomalies. * History of previous uterine surgery * Any contraindication to Sildenafil as Previous history of cardiac disease or stroke.

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.

What they're measuring

Clinical Pregnancy rate

Timeframe: 2 weeks after embryo transfer

Trial details

NCT IDNCT04283435

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-01

Contact for this trial

Eman Elkattan, MD

01212529213 emyelkattan@gmail.com

View on ClinicalTrials.gov More IVF trials