NCT05753098

Brief Summary

. This study aimed to determine and compare the effect of vaginal sildenafil citrate and estradiol valerate on endometrial thickness, blood flow and pregnancy rates in infertile women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2021

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

January 15, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

February 21, 2023

Last Update Submit

April 26, 2023

Conditions

Subfertility, Female

Outcome Measures

Primary Outcomes (1)

  • pregnancy rates

    measure B HCG and detect number of cases get pregnant in each cycle 28 days

    at the end of each of 3 cycles (28 days)

Secondary Outcomes (1)

  • ovulation

    3 months

Study Arms (3)

estrogen therapy in addition to clomiphene citrate

EXPERIMENTAL

received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle and estrogen (Cyclopregnova® 2mg, white tablets, BAYER Schering pharma), one tablet every 12 hour from day 8th till triggering of ovulation.

Drug: estrogen therapyDrug: Clomiphene Citrate 50mg

sildenafil in addition to clomiphene citrate

EXPERIMENTAL

received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle as and Sildenafil (Respatio® 20mg film coated tablets for 5 days) from last day of menstruation till reaching optimal size of follicle and endometrial thickness

Drug: SildenafilDrug: Clomiphene Citrate 50mg

clomiphene citrate alone

OTHER

received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle as in the first and second groups in addition to placebo tablet.

Drug: Clomiphene Citrate 50mg

Interventions

estrogen therapyDRUG

oral estradiol valerate

Also known as: white tablet of cycloprogynova
estrogen therapy in addition to clomiphene citrate
SildenafilDRUG

PDE5 inhibitor

Also known as: Respatio
sildenafil in addition to clomiphene citrate
Clomiphene Citrate 50mgDRUG

used for ovulation induction

Also known as: Technovula
clomiphene citrate aloneestrogen therapy in addition to clomiphene citratesildenafil in addition to clomiphene citrate

Eligibility Criteria

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

You may qualify if:

  • aged between 18 to 40 years
  • unexplained infertility (primary or secondary)
  • had a regular menstrual cycle;
  • patent tubes;
  • husbands with normal semen parameters.

You may not qualify if:

  • hypotension;
  • cardiovascular, hepatic, and renal diseases;
  • uncontrolled diabetes mellitus;
  • anovulatory infertility;
  • ovarian cysts;
  • pelvic adhesions;
  • hyperprolactinemia;
  • abnormal thyroid functions;
  • multiple uterine fibroids;
  • patients on nitrates;
  • suspicion of endometriosis and adenomyosis,
  • subjects have known to receive any treatment for fertility in the last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-suef university

Banī Suwayf, Egypt

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Estrogen Replacement TherapySildenafil CitrateClomiphene

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Hormone Replacement TherapyDrug TherapyTherapeuticsSulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Beni-Suef University

    Clinical Pharmacy Faculty of Pharmacy Beni-Suef University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
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

February 21, 2023

First Posted

March 3, 2023

Study Start

January 15, 2021

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)