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Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs

Information source: Ain Shams University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: PCOS

Intervention: Clomiphene citrate (Drug); Tamoxifen Placebo (Drug); Tamoxifen (Drug); Clomiphene citrate placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Ain Shams University

Official(s) and/or principal investigator(s):
Gasser M. El-Bishry, FRCOG, Study Director, Affiliation: Professor of Obstetrics and Gynaecology, Ain Shams University
Abdel-Latif G. El-Kholy, MD, Principal Investigator, Affiliation: Assistant professor of Obstetrics and Gynaecology, Ain Shams University
Mohamed S. Sweed, MD, Principal Investigator, Affiliation: Lecturer of Obstetrics and Gynaecology, Ain Shams University
Diana N. Kolta, MB BCh, Principal Investigator, Affiliation: Resident of Obstetrics and Gynaecology

Overall contact:
Mohamed S Sweed, MD, Phone: 01001222047, Ext: +2, Email: drmsweed@gmail.com

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Primary outcome: Rate of ovulation.

Secondary outcome:

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.

Endometrial thickness and quality in the pre-ovulatory period.

Number of growing follicles detected by transvaginal ultrasound.

Pregnancy rate both clinical and biochemical.

Patient compliance.

Adverse effects: such as headache, nausea, vomiting, breast tenderness, blurred vision, and ovarian enlargement or hyperstimulation.

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

Mohamed S Sweed, MD, Phone: 01001222047, Ext: +2, Email: drmsweed@gmail.com

Ain Shams University Maternity Hospital, Cairo, Egypt; Recruiting
Mohamed S. Sweed, MD, Principal Investigator
Additional Information

Starting date: June 2015
Last updated: June 19, 2015

Page last updated: August 23, 2015

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