NCT02890238

Brief Summary

100 women with infertility classified into 2 groups. Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day. Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.

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
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2016

Typical duration for phase_4

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

August 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

3.2 years

First QC Date

August 29, 2016

Last Update Submit

September 20, 2019

Conditions

Infertility

Keywords

Sildenafil CitrateInduction of OvulationPregnancy Rate

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate per cycle

    Serum pregnancy test

    14 days after HCG triggering of ovulation

Study Arms (2)

sildenafil citrate

ACTIVE COMPARATOR

50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd - 7th day of the cycle and sildenafil citrate 20mg tab from 7th-11th day of the same cycle orally 3times/day

Drug: Clomiphene citrateDrug: sildenafil citrate

placebo group

PLACEBO COMPARATOR

50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd- 7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day

Drug: Clomiphene citrateDrug: Placebo

Interventions

Clomiphene citrateDRUG

50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle

Also known as: clomid
placebo groupsildenafil citrate
sildenafil citrateDRUG

20mg tab from 7th-11th day of the same cycle orally 3times/day

Also known as: Viagra
sildenafil citrate
PlaceboDRUG

tab from 7th-11th day of the same cycle orally 3times/day

placebo group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile women whether it's primary or secondary infertility
  • Woman's age: (18-35 years old)
  • Menstrual cycle from (24-35 days)
  • Normal semen analysis

You may not qualify if:

  • Age more than 35 years old
  • Ovarian cysts
  • Abnormal hormonal profile (e.g hyperprolactinaemia)
  • Significant cardiovascular disease
  • Serious liver disease or renal failure
  • Poorly controlled diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

ClomipheneSildenafil Citrate

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSulfonamidesAmidesSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ahmed Maged

    Kasr Alainy medical school

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged

CONTACT

01005227404prof.ahmedmaged@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 7, 2016

Study Start

August 1, 2016

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

Locations

EG(1)