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

Sponsor

Beni-Suef University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05971667

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

66.2

Patients Per Site Per Month

Study Details

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Jul 30, 2023

Anticipated Primary Completion Date :

Oct 30, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Beni-suef university Hospital	Banī Suwayf	Beni Suef	Egypt	62521

Sponsors and Collaborators

Beni-Suef University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Aug 2, 2023

Last Update Posted:

Aug 3, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sara Abdallah Mohamed Salem, Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University

Tadalafil

Sildenafil

pentoxyfylline

frozen embryo transfer

Additional relevant MeSH terms:

Sildenafil Citrate

Tadalafil

Pentoxifylline

Study Results

No Results Posted as of Aug 3, 2023