NCT05971667

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

July 30, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

July 25, 2023

Last Update Submit

August 1, 2023

Conditions

IVF

Keywords

TadalafilSildenafilpentoxyfyllinefrozen embryo transfer

Outcome Measures

Primary Outcomes (1)

  • endometrial thickness

    measured by transvaginal ultrasound

    within 16 day of menstruation

Secondary Outcomes (1)

  • pregnancy rate

    1 month

Study Arms (4)

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

tadalafilDRUG

tadalafil 10 mg one tablet daily

Also known as: cialong
tadalafil
SildenafilDRUG

sildenafil 20 mg two tablets daily

Also known as: Respatio
sildenafil
pentoxifyllineDRUG

pentoxifylline 400 mg two tabs daily

Also known as: trental
pentoxifylline

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women having thawed embryos

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

MeSH Terms

Interventions

TadalafilSildenafil CitratePentoxifylline

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingSulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesPurinesTheobromineXanthinesPurinones

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 2, 2023

Study Start

July 30, 2023

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

August 3, 2023

Record last verified: 2023-08

Locations

EG(1)