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CompletedNCT02663830Updated Aug 16, 2017

The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene

A Phase 2 interventional study of Sildenafil & clomiphene citrate and clomiphene only in Anovulatory, sponsored by Ain Shams University. Completed. Open to female participants aged 21 Years to 35 Years. Per ClinicalTrials.gov, last updated 2017-08-16.

Sponsored by Ain Shams University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
21 Years to 35 Years
Sex
Female
01

Study summary

The aim of the study is to evaluate the effect of sildenafil citrate on the pregnancy rate in women undergoing induction of ovulation using clomiphene citrate.

02

Conditions studied

  • Anovulatory

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03

In context

Anovulation

75 studies on the registry are indexed under Anovulation; 7 are open to participants now.

This study's enrollment of 210 is above the median of 80 across 52 interventional studies indexed under Anovulation.

Browse Anovulation studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women age 21-35 years.
  • Anovulatory cycles due to polycystic ovaries syndrome.
  • Non-smokers.
  • Free of major medical illness

Exclusion criteria

Exclusion Criteria:

  • Women with myoma or adenomyosis
  • Women with congenital uterine anomaly.
  • Chronic use of any medications including non-steroidal anti-inflammatory drugs.
  • Associated cases of infertility other than PCOs (male factor, tubal factor,....).
  • Asherman syndrome.
  • Cases with endometrial hyperplasia.
  • Cases with endometrial polyp
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
210 participants (actual)

Study arms

  • Experimental
    (Sildenafil & clomiphene citrate group)

    105 Patients will receive 25 mg sildenafil citrate 6 hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation

    Drug: Sildenafil & clomiphene citrate

  • Active comparator
    clomiphene only

    105 patients will receive only clomiphene citrate 100mg/day (day 2 to 6) orally (2 tablets at same time daily).

    Drug: clomiphene only

Interventions

  • DrugSildenafil & clomiphene citrate

    Drug pages: Sildenafil · Clomiphene

    105 Patients will receive 25 mg sildenafil citrate 6hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation

    Also known as: seldin and clomid

  • 105 Patients will receive clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation

    Also known as: clomid

06

What researchers measure

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 6 weeks

Secondary outcomes

  1. endometrial thickness

    Time frame: 2 weeks

  2. miscarriage rate

    Time frame: 13 weeks

  3. ectopic pregnancy rate

    Time frame: 8 weeks

  4. Side Effects of Vasodilators

    Time frame: 4 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2016 to primary completion in Jan 2017, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 21, 2016
First posted
Jan 26, 2016
StartActual
Jan 10, 2016
Primary completionActual
Jan 10, 2017
CompletionActual
Mar 12, 2017
Last update
Aug 16, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02663830
Responsible party
Ahmed Abdel Shafy El Shahawy (Lecturer, Ain Shams University) — Principal investigator
First posted
Jan 26, 2016
Start date
Jan 10, 2016
Primary completion
Jan 10, 2017
Completion
Mar 12, 2017
Last update
Aug 16, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Sildenafil · Clomiphene

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