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NCT04283435
Endometrial Effects of Sildenafil in Frozen-Thawed Cycles in Women With Thin Endometrium
Phase 1 trial testing Sildenafil Citrate in IVF in 100 participants. Status unknown.
1 March 2022
Quick facts
| Lead sponsor | Cairo University |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 September 2021 |
| Primary completion | 1 March 2022 |
| Estimated completion | 1 March 2022 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Sildenafil Citrate (Sildenafil Citrate) — full drug profile →
- Placebo
- Estradiol Valerate (ESTRADIOL VALERATE) — full drug profile →
Conditions studied
- IVF — all drugs for IVF →
- Endometrial Receptivity — all drugs for Endometrial Receptivity →
Sponsor
Cairo University
Who can join
Adults 25 to 40, female only, with IVF or Endometrial Receptivity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Vasodilators for women undergoing fertility treatment.
Gutarra-Vilchez RB, Vazquez JC, Glujovsky D, Lizaraso F, et al · · 2025 · cited 2× · PMID 40047216 · DOI 10.1002/14651858.cd010001.pub4
Verify or expand the search:
- PubMed search for NCT04283435
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sildenafil Citrate
Trials testing the same drug.
- NCT06178523 — Cost-effective Treatment of Unexplained Infertility · Phase 4 · completed
- NCT05951413 — The Effect of Sildenafil Citrate on Frozen Embryo Transfer Cycles · Phase 2, PHASE3 · unknown
- NCT05846906 — Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness · Phase 2, PHASE3 · completed
- NCT04565925 — Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries · Phase 2 · recruiting
- NCT04898114 — Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn · Phase 1, PHASE2 · recruiting
Other recruiting trials for IVF
Currently open trials in the same condition.
- NCT07364526 — Non-Invasive Preimplantation Genetic Screening for Aneuploidies and Clinical Outcomes in Egg Donation Patients · recruiting
- NCT07088640 — Single Step Protocol and Multi-step Warming Protocol for Blastocyst FET · NA · recruiting
- NCT06544837 — Trial to Evaluate the Clinical Utility of Non-invasive Endometrial Receptivity Test (Ora) in Patients With Implantation · NA · recruiting
- NCT06334003 — Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology · recruiting
- NCT06577181 — Effect of HCG on Endometrial Preparation in Frozen Embryo Transfer · active not recruiting
Other Cairo University trials
Trials by the same sponsor.
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- NCT07381153 — In-Vitro Cytotoxicity Assessment of INOX (Nanoksa G Plus) Polymer Discs · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04283435 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cairo University
- Last refreshed: 20 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04283435.
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