- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03755037
Clomiphene Citrate, Estradiol and Sildenafil for Induction of Ovulation in Unexplained Infertility
Clomiphine Citrate and Estradiol Versus Clomiphine Citrate and Sildenafil in Comparison With Clomiphine Citrate Alone for Induction of Ovulation in Unexplained Infertility: Double Blind Randomised Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Clomiphene citrate has been widely used alone, and in combination with intrauterine insemination (IUI), for treatment of unexplained subfertility, The mechanism of action is based on its mixed estrogenic and antiestrogenic properties. Clomiphene is frequently used to treat unexplained female infertility by inducing multifollicular response and correcting potential subtle ovulatory dysfunction .,)The American Society for Reproductive Medicine,2003).
The use of clomiphene citrate decreases the uterine blood flow during the early luteal phase, a periimplantation stage., )The American College of Obstetricians and Gynecologists,1995).
Although ovulation is found in 80% of women with a cumulative effect in 6-8 months, the pregnancy rate can still be very low in these women . The possible causes are the anti-estrogenic effects of CC at the endometrium and cervical mucus level . The endometrial effect is without doubt one of the most important handicaps in infertility treatment. The pregnancy rate can be very low, especially if the endometrial thickness (ET) is <6-8 mm ., )J Turk Ger Gynecol Assoc. ,2012).
Ethinyl E2 reverse the deleterious effect of CC on endometrial development during the follicular phase. Endometrial thickness was dependent on peak E2 concentrations in serum.,(Richard P. Dickey, et.al.,2003).
Sildenafil citrate could lead to an improvement in uterine blood flow and, in conjunction with estrogen, led to the estrogen-induced proliferation of the endometrial lining .
Sildenafil citrate enhances uterine blood flow and increases endometrial thickening . The achieved implantation depends on the blastocyst's ability to infiltrate the endometrium and develop a sustaining blood supply, which requires the following genes to produce the necessary proteins for digesting the endometrial cellular matrix, to regulate cell growth, and to induce angiogenesis (Razieh Dehghani Firouzabadi,et.al.,2013).
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11412
- Nesreen Abd El Fattah Abd Allah
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women whose infertility tests were normal then diagnosed as unexplained infertility.
Exclusion Criteria:
- Any cause of infertility male factor, tubal or ovarian.
- Chronic illness as cardiac or renal disease
- Any contraindication for used drugs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Estradiol and cc
Group 1 received estradiol, cc and placebo simillar to sildenafil for induction of ovulation. CC 50 mg (clomid) orally twice daily from 3rd day to 7th day of menstrual cycle of the patient then ethinyl estradiol 0.05mg orally twice daily on the 8th day of same cycle till 11th day. |
Drugs were received during the menstrual cycle.
|
Active Comparator: Sildenafil and cc
Group 2 received CC 50 mg (clomid) orally twice daily from 3rd day to 7th day of menstrual cycle of the patient, sildenafil citrate (Respatio) 20 mg tab orally 3 times daily from8th day of same cycle till 11th day and placebo simillar to estradiol.
|
Drugs were received during the menstrual cycle.
|
Placebo Comparator: Placebo and cc
Group 3 received cc and placebo similar to sildenafil and placebo similar to estradiol with the same doses.
|
Drugs were received during the menstrual cycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultrasound parameters
Time Frame: at day 14 until day 17 of menstrual cycle
|
Number of follicles in each ovary and endometrial thickness
|
at day 14 until day 17 of menstrual cycle
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pregnancy
Time Frame: at day 21 and 24 of menstrual cycle
|
A serum pregnancy test was done
|
at day 21 and 24 of menstrual cycle
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 1. Alexander Quaas, MD, Ph .D .,and Anuja Dokras, MD . diagnosis and treatment of unexplainrd infertilityRev Obstet Gynecol. 2008 Spring; 1(2): 69-76 2. J Turk Ger Gynecol Assoc.: The effect of administering estrogen to clomiphene citrate stimulated cycles on endometrial thickness and pregnancy rates in unexplained infertility. (2012) . Sep 1;13(3):157-61. 3. Paulus WE, Strehler E, Zhang M, Jelinkova L,El-Danasouri I and Sterzik K. : Benefit of sildenafil citrate in assisted reproductivetherapy. Fertil Steri 2002 Apr;77(4):846-7. 4. Razieh Dehghani Firouzabadi, M.D., Robab Davar, M.D., Farzaneh Hojjat, M.D., and Mohamad Mahdavi, M.D. :effect of sildenafil on endomeerial preparation and outcome of frozen_thawed embryo transfer cycles(. Iran J Reprod Med. 2013 Feb; 11(2): 151-158. 5. Richard P. Dickey, M.D., Ph.D.,):clomiphene citrate for woman with unexplained infertility . pp 261-271 13 May 2015 6. The American Society for Reproductive Medicine. Use of clomiphene citrate in infertile women:. Fertil Steril . Fertil Steril. 2013 Aug;100(2):341-8. doi: 10.1016/j.fertnstert.2013.05.033. Epub 2013 Jun 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infertility
- Infertility, Female
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Hormonal
- Estradiol
- Ethinyl Estradiol
Other Study ID Numbers
- Beni-Suef 16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Female Infertility
-
Esraa Gamal AhmedAin Shams Maternity HospitalUnknownUnexplained Female Infertility
-
Pacific Fertility CenterTerminatedPrimary Female Infertility | Secondary Female Infertility
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Newlife Fertility CentreRecruitingInfertility | Infertility,Female | Infertility Unexplained | Infertility of Uterine Origin | Infertility; Female, NonimplantationCanada
-
Wake Forest University Health SciencesWithdrawnUterine Diseases | Endometriosis | Infertility Unexplained | Endometrial Diseases | Infertility; Female, NonimplantationUnited States
-
Cairo UniversityCompleted
-
Navy General Hospital, BeijingUnknownFemale Infertility Due to Nonimplantation of OvumChina
-
Sapientiae InstituteTerminated
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
IVI MadridCompletedFemale Infertility Due to Advanced Maternal AgeSpain
Clinical Trials on Clomid, Respatio and Ethinyl estradiol
-
Teva Branded Pharmaceutical Products R&D, Inc.CompletedOral Contraceptive | HemostasisGermany, Israel, Italy, Spain
-
Teva Pharmaceuticals USACompletedHealthyUnited States
-
Ortho-McNeil Janssen Scientific Affairs, LLCCompleted
-
Teva Pharmaceuticals USACompletedHealthyUnited States
-
NewAmsterdam PharmaNovumRecruitingHealthy VolunteersUnited States
-
University of OuluCompleted
-
Oregon Health and Science UniversityNational Institutes of Health (NIH); Oregon Clinical and Translational Research...Completed
-
The Jones InstituteUnknownPostpartum Depressive Mood | Postpartum Sexual FunctionUnited States
-
The Hospital for Sick ChildrenThe Physicians' Services Incorporated FoundationUnknown
-
Laboratorios Andromaco S.A.CompletedTherapeutic EquivalencyIndia