NCT03854175

Brief Summary

A total of 80 Patients who meet these conditions will enter the study and be divided into two groups based on randomized tables. To prepare the endometrium, Group A : 40 women are given oral estradiol valerate tablets 2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium Group B : 40 women are give sildenafil citrate 25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle, in addition to oral 2mg of estradiol valerat 6-8 hourly from the day 2-14 of the menstrual cycle . Estrogen and progesterone (prontogest 400mg pessaries ) are given 3 days prior to embryo transfer. Sildenafil is discontinued 48-72 hours prior to the embryo transfe due sildenafil may have some detrimental effects on endometrium in the implantation window

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

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

Study Start

First participant enrolled

February 1, 2019

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

February 23, 2019

Last Update Submit

February 23, 2019

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • endometrial thickness

    ultrasound measurement of the endometrial thickness at the fundus

    At the day of embryo transfer

Secondary Outcomes (2)

  • Endometrial vascularity

    At the day of embryo transfer

  • clinical pregnancy rate

    4 weeks after embryo transfer

Study Arms (2)

Sildenafil group

ACTIVE COMPARATOR

40 women are give sildenafil citrate 25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle, in addition to oral 2mg of estradiol valerat 6-8 hourly from the day 2-14 of the menstrual cycle

Drug: sildenafil citrateDrug: Estradiol Valerate 2 MG

estradiol group

ACTIVE COMPARATOR

40 women are given oral estradiol valerate tablets 2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium in addition to placebo in the same way as sildenafil

Drug: Estradiol Valerate 2 MG

Interventions

sildenafil citrateDRUG

25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle

Sildenafil group
Estradiol Valerate 2 MGDRUG

2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium

Sildenafil groupestradiol group

Eligibility Criteria

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

You may qualify if:

  • Women undergoing their first frozen embryo transfer cycle.
  • have at least two high quality frozen embryos

You may not qualify if:

  • \. a history of endocrine diseases. 2. a history of hysteroscopic surgeries. 3. cardiovascular, renal and liver diseases. 4. hypotension (blood pressure \<90/50 mmHg). 5. a history of stroke or myocardial infarction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

Sildenafil CitrateEstradiol

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Ahmed Maged, MD

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+201005227404prof.ahmedmaged@gmail.com

Ahmed Said, MSc

CONTACT

01013903948Medo_said14@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 23, 2019

First Posted

February 26, 2019

Study Start

February 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

EG(1)