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Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs

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ClinicalTrials.gov Identifier: NCT02479256
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Mohamed S Sweed, MD, Ain Shams University

Brief Summary:
Comparison between Clomiphene citrate and Tamoxifen for induction of ovulation in women with PCOS.

Condition or disease Intervention/treatment Phase
PCOS Drug: Clomiphene citrate Drug: Tamoxifen Placebo Drug: Tamoxifen Drug: Clomiphene citrate placebo Phase 4

Detailed Description:

Participants fulfilling inclusion and exclusion criteria will be divided into two groups, each group containing 300 participants;

Group (A):

300 participants will receive Clomiphene citrate oral tablets and placebo of Tamoxifen oral tablets.

Group (B):

300 participants will receive Tamoxifen oral tablets and placebo of Clomiphene oral tablets.

Participants with abnormal menstrual history will receive two tablets of norethisterone 5mg tab (Steronate nor ®, hi pharm/Egypt) every12 hours for 5 days to withdraw period before starting the procedure.

Then;

Group (A):

Women will receive one tablet of clomiphene citrate oral tablets 50 mg (Clomid®, aventis/Egypt) twice daily 12 hours apart (total dose 100 mg daily), and one tablet of placebo of tamoxifen oral tablets twice daily 12 hours apart from the 3rd day of the menses for 5 days, for only one menstrual cycle.

Group (B):

Women will receive one tablet of tamoxifen oral tablets 10 mg (Tamoxifen®, amriya/Egypt) twice daily 12 hours apart (total dose 20 mg daily), and one tablet of placebo of clomiphene citrate twice daily 12 hours apart from 3rd day of the menses for 5 days, for only one menstrual cycle.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Clomiphene Citrate Versus Tamoxifen for Induction of Ovulation in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial
Study Start Date : June 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016


Arm Intervention/treatment
Experimental: Clomiphene citrate + placebo
Women will receive one tablet of clomiphene citrate oral tablets 50 mg (Clomid®, aventis/Egypt) twice daily 12 hours apart (total dose 100 mg daily), and one tablet of placebo of tamoxifen oral tablets twice daily 12 hours apart from the 3rd day of the menses for 5 days, for only one menstrual cycle.
Drug: Clomiphene citrate
Women will receive one tablet of clomiphene citrate oral tablets 50 mg (Clomid®, aventis/Egypt) twice daily 12 hours apart (total dose 100 mg daily) from the 3rd day of the menses for 5 days, for only one menstrual cycle.
Other Name: Clomid

Drug: Tamoxifen Placebo
Women will receive one tablet of placebo of tamoxifen oral tablets twice daily 12 hours apart from the 3rd day of the menses for 5 days, for only one menstrual cycle.

Experimental: Tamoxifen + placebo
Women will receive one tablet of tamoxifen oral tablets 10 mg (Tamoxifen®, amriya/Egypt) twice daily 12 hours apart (total dose 20 mg daily), and one tablet of placebo of clomiphene citrate twice daily 12 hours apart from 3rd day of the menses for 5 days, for only one menstrual cycle.
Drug: Tamoxifen
Women will receive one tablet of tamoxifen oral tablets 10 mg (Tamoxifen®, amriya/Egypt) twice daily 12 hours apart (total dose 20 mg daily) from 3rd day of the menses for 5 days, for only one menstrual cycle.

Drug: Clomiphene citrate placebo
Women will receive one tablet of placebo of clomiphene citrate twice daily 12 hours apart from 3rd day of the menses for 5 days, for only one menstrual cycle.




Primary Outcome Measures :
  1. Rate of ovulation. [ Time Frame: Up to 4 weeks from starting treatment. ]
    • Transvaginal ultrasound done to:

      1. Detect signs of ovulation: corpus luteum, fluid in cul-de-sac, collapse of the follicle size.

    • Serum progesterone will be measured in the mid luteal day of the cycle, where:

      1. Level 6 ng/ml or 19 nmol/L indicates Ovulation.
      2. Level <5 nmol/L suggests Ovulation did not occur.


Secondary Outcome Measures :
  1. Endometrial perfusion by using 3D- power Doppler (GE Medical system volouson E6, 5-7 MHz) in the mid luteal day of the cycle to assess endometrial receptivity. [ Time Frame: Up to 4 weeks from starting treatment. ]

    Endometrial perfusion by using 3D-power Doppler (GE Medical system volouson E6, 5-7 MHz) at Ain-Shams University Maternity Hospital will be done in the mid luteal day of the menstrual cycle to assess endometrial receptivity by measured:

    • Gray: mean Gray value.
    • Color angio: Flow index, Vascularization index, and Vascularization flow Index.

  2. Endometrial thickness and quality in the pre-ovulatory period. [ Time Frame: Up to 4 weeks from starting treatment. ]

    Transvaginal ultrasound will be done to:

    Evaluate endometrial thickness and quality pre-ovulatory: where the minimal endometrial thickness to achieve a pregnancy ranges from 4 to 7mm with a healthy trilaminar appearance.


  3. Number of growing follicles detected by transvaginal ultrasound. [ Time Frame: Up to 4 weeks from starting treatment. ]

    Transvaginal ultrasound will be done to:

    Detect mean follicular diameter in the days 10, 12, 14 and up to day 25 of the cycle.


  4. Pregnancy rate both clinical and biochemical. [ Time Frame: Up to 8 weeks from starting treatment. ]

    Transvaginal ultrasound done to:

    1. Evaluate endometrial thickness and quality in the mid luteal day of the cycle: where the optimal endometrial thickness to achieve a pregnancy ranging from 10 to 15mm with a healthy trilaminar appearance.
    2. Detect gestational and fetal pulsation.

  5. Patient compliance. [ Time Frame: Up to 4 weeks from starting treatment. ]
    Asking the participant about the empty strips.

  6. Adverse effects: such as headache, nausea, vomiting, breast tenderness, blurred vision, and ovarian enlargement or hyperstimulation. [ Time Frame: Up to 4 weeks from starting treatment. ]
    Asking the participant if there are any complaints about the side effects of the drugs.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary infertility.
  • Body mass index (BMI) between 25 and 30 Kg/m 2.
  • Polycystic ovary syndrome (using ESHRE/ASRM criteria).

Exclusion Criteria:

  • Secondary infertility.
  • Patients with BMI under 25 or over 30 Kg/m 2.
  • Hyper or hypothyroidism, or hyperprolactinemia.
  • Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs.
  • Intention to start a diet or a specific program of physical activity.
  • Organic pelvic diseases.
  • Tubal or male factor infertility.
  • Interval of earlier treatment with any of the fertility drugs of less than 6 months.
  • Contraindication to either:

    • Clomiphene citrate.
    • Tamoxifen.
    • HCG injection.

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): NCT02479256


Locations
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Egypt
Ain Shams University Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Gasser M. El-Bishry, FRCOG Professor of Obstetrics and Gynaecology, Ain Shams University
Principal Investigator: Abdel-Latif G. El-Kholy, MD Assistant professor of Obstetrics and Gynaecology, Ain Shams University
Principal Investigator: Mohamed S. Sweed, MD Lecturer of Obstetrics and Gynaecology, Ain Shams University
Principal Investigator: Diana N. Kolta, MB BCh Resident of Obstetrics and Gynaecology

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Responsible Party: Mohamed S Sweed, MD, Lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT02479256     History of Changes
Other Study ID Numbers: 20092009
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016

Keywords provided by Mohamed S Sweed, MD, Ain Shams University:
PCOS
Induction of ovulation
Clomiphene citrate
Tamoxifen

Additional relevant MeSH terms:
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Citric Acid
Sodium Citrate
Tamoxifen
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents