Effect of Tadalafil, Sildenafil and Pentoxyfylline on Frozen Embryo Transfer Outcomes

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ClinicalTrials.gov Identifier: NCT05971667

Recruitment Status : Not yet recruiting

First Posted : August 2, 2023

Last Update Posted : August 3, 2023

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Sponsor:

Information provided by (Responsible Party):

Sara Abdallah Mohamed Salem, Beni-Suef University

Study Description

Brief Summary:

The aim of this study is to investigate the Effect of different vasodilators as Tadalafil, Sildenafil and pentoxyfylline in In vitro Fertilization. In addition, the thickness of endometrium and pregnancies rates of these women will also be examined. All adverse effects of all drugs will be estimated

Condition or disease	Intervention/treatment	Phase
IVF	Drug: tadalafil Drug: Sildenafil Drug: pentoxifylline	Phase 2 Phase 3

Detailed Description:

A prospective randomized clinical study will be conducted in the IVF clinic of the gynecology department of Beni Suef University Hospital, Beni-Suef, Egypt. The study will These patients will be randomized into four groups.

The participants will take drugs starting from the end of menstruation cycle till endometrium reach optimal and then will start progesterone 800 mg daily.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	"Effect of Tadalafil, Sildenafil and Pentoxyfylline on Endometrial Thickness and Frozen Embryo Transfer Outcomes
Estimated Study Start Date :	July 30, 2023
Estimated Primary Completion Date :	October 30, 2023
Estimated Study Completion Date :	October 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Pentoxifylline Sildenafil Tadalafil Sildenafil citrate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: tadalafil tadalafil 10 mg one tablet daily	Drug: tadalafil tadalafil 10 mg one tablet daily Other Name: cialong
Experimental: pentoxifylline pentoxyfilline 400 mg two tabs daily	Drug: pentoxifylline pentoxifylline 400 mg two tabs daily Other Name: trental
Experimental: sildenafil sildenafil 20 mg two tablets	Drug: Sildenafil sildenafil 20 mg two tablets daily Other Name: Respatio
No Intervention: control group. no intervention is given

Outcome Measures

Primary Outcome Measures :

endometrial thickness [ Time Frame: within 16 day of menstruation ]
measured by transvaginal ultrasound

Secondary Outcome Measures :

pregnancy rate [ Time Frame: 1 month ]
number of cases positive serum pregnancy test

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

women having thawed embryos

Exclusion Criteria:

hypotension
cardiovascular, hepatic, and renal diseases;
uncontrolled diabetes mellitus;
ovarian cysts;
hyperprolactinemia;
abnormal thyroid functions;
uterine fibroids;
patients taking nitrates;
endometriosis and adenomyosis

Contacts and Locations

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): NCT05971667

Locations

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Egypt
Beni-suef university Hospital
Banī Suwayf, Beni Suef, Egypt, 62521

Sponsors and Collaborators

Beni-Suef University

More Information

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Responsible Party:	Sara Abdallah Mohamed Salem, Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University
ClinicalTrials.gov Identifier:	NCT05971667
Other Study ID Numbers:	Tadalafil IVF
First Posted:	August 2, 2023 Key Record Dates
Last Update Posted:	August 3, 2023
Last Verified:	August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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

Keywords provided by Sara Abdallah Mohamed Salem, Beni-Suef University:


Tadalafil Sildenafil pentoxyfylline frozen embryo transfer

Additional relevant MeSH terms:

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Sildenafil Citrate Tadalafil Pentoxifylline Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action	Urological Agents Platelet Aggregation Inhibitors Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Free Radical Scavengers Antioxidants

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