Sildenafil Effect After Ovulation Induction | NCT02890238

Studies
Sildenafil Effect After Ovulation Induction

NCT02890238

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Sep 23, 2019Actual

Enrollment

100Estimated

Phase

Phase 4

Conditions

Infertility

Interventions

Clomiphene citrate
sildenafil citrate
Placebo

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

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Oct 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Aug 29, 2016

First Submission Date that Met QC Criteria

Aug 31, 2016

First Posted Date

Sep 7, 2016Estimated

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

Sep 20, 2019

Last Update Posted Date

Sep 23, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed M Maged, MD, Assistant professor, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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.

Detailed Description

100 women with infertility classified into 2 groups.

Folliculometry was assessed by:

Transvaginal ultrasound: It was done on day 11th of the cycle to detect number of follicles and endometrial thickness.

When the follicles reach ≥18 ml, injection of 5000 IU of HCG IM to trigger ovulation to both groups.

Pregnancy was assessed by:

Beta HCG test: (Radioimmunoassay)

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 citrate Drug: 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 citrate Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clomiphene citrate	Drug	50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle	placebo group sildenafil citrate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pregnancy rate per cycle	Serum pregnancy test	14 days after HCG triggering of ovulation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Maged	Contact	01005227404		prof.ahmedmaged@gmail.com

Overall Officials

Name	Affiliation	Role
Ahmed Maged	Kasr Alainy medical school	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr Alainy medical school	Recruiting	Cairo		12151	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002996	Clomiphene
D000068677	Sildenafil Citrate

Ancestor Terms

ID	Term
D013267	Stilbenes
D001597	Benzylidene Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided