Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Sildenafil Effect After Ovulation Induction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890238
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed M Maged, MD, Cairo University

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.


Condition or disease Intervention/treatment Phase
Infertility Drug: Clomiphene citrate Drug: sildenafil citrate Drug: Placebo Phase 4

Detailed Description:

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.

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)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Sildenafil Citrate on Pregnancy Rate in Women Undergoing Induction of Ovulation
Study Start Date : August 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Active Comparator: sildenafil citrate
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
50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle
Other Name: clomid

Drug: sildenafil citrate
20mg tab from 7th-11th day of the same cycle orally 3times/day
Other Name: Viagra

Placebo Comparator: placebo group
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
50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle
Other Name: clomid

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




Primary Outcome Measures :
  1. Pregnancy rate per cycle [ Time Frame: 14 days after HCG triggering of ovulation ]
    Serum pregnancy test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890238


Contacts
Layout table for location contacts
Contact: Ahmed Maged 01005227404 prof.ahmedmaged@gmail.com

Locations
Layout table for location information
Egypt
Kasr Alainy medical school Recruiting
Cairo, Egypt, 12151
Contact: Ahmed Maged, MD    01005227404    prof.ahmedmaged@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Principal Investigator: Ahmed Maged Kasr Alainy medical school

Layout table for additonal information
Responsible Party: Ahmed M Maged, MD, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT02890238    
Other Study ID Numbers: 156
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Ahmed M Maged, MD, Cairo University:
Sildenafil Citrate
Induction of Ovulation
Pregnancy Rate
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Genital Diseases, Male
Genital Diseases, Female
Sildenafil Citrate
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators