Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs

May 15, 2016 updated by: Mohamed S Sweed, MD, Ain Shams University

Clomiphene Citrate Versus Tamoxifen for Induction of Ovulation in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain shams university maternity hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 4 weeks from starting treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 4 weeks from starting treatment.
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.
Up to 4 weeks from starting treatment.
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.
Up to 4 weeks from starting treatment.
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.
Up to 8 weeks from starting treatment.
Patient compliance.
Time Frame: Up to 4 weeks from starting treatment.
Asking the participant about the empty strips.
Up to 4 weeks from starting treatment.
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.
Up to 4 weeks from starting treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

June 19, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Estimate)

May 17, 2016

Last Update Submitted That Met QC Criteria

May 15, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20092009

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.

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