Effect of Tadalafil, Sildenafil and Pentoxyfylline on Fro... | NCT05971667

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

NCT05971667

Sponsor

Beni-Suef University

Status

Unknown status

Last Update Posted

Aug 3, 2023Actual

Enrollment

200Estimated

Phase

Phase 2Phase 3

Conditions

Interventions

tadalafil
Sildenafil
pentoxifylline

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 30, 2023Estimated

Primary Completion Date

Oct 30, 2023Estimated

Completion Date

Oct 30, 2023Estimated

First Submitted Date

Jul 25, 2023

First Submission Date that Met QC Criteria

Jul 25, 2023

First Posted Date

Aug 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2023

Last Update Posted Date

Aug 3, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sara Abdallah Mohamed Salem, Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef UniversityPrincipal Investigator

Lead Sponsor

Beni-Suef UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tadalafil	Experimental	tadalafil 10 mg one tablet daily	Drug: tadalafil
pentoxifylline	Experimental	pentoxyfilline 400 mg two tabs daily	Drug: pentoxifylline
sildenafil	Experimental	sildenafil 20 mg two tablets	Drug: Sildenafil
control group.	No Intervention	no intervention is given

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tadalafil	Drug	tadalafil 10 mg one tablet daily	tadalafil	cialong

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
endometrial thickness	measured by transvaginal ultrasound	within 16 day of menstruation

Secondary Outcomes

Measure	Description	Time Frame
pregnancy rate	number of cases positive serum pregnancy test	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beni-suef university Hospital		Banī Suwayf	Beni Suweif Governorate	62521	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068581	Tadalafil
D000068677	Sildenafil Citrate
D010431	Pentoxifylline

Ancestor Terms

ID	Term
D002243	Carbolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided