Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs

PCOS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02479256
• Other study ID #: 20092009
• Status: Recruiting
• Phase: Phase 4
• First received: April 13, 2015
• Last updated: February 14, 2016
• Start date: June 2015
• Est. completion date: March 2016

Study information

• Verified date: February 2016
• Source: Ain Shams University
• Contact: Mohamed S Sweed, MD
• Phone: 01001222047
• Email: drmsweed[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• PCOS

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of ovulation.	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: Level 6 ng/ml or 19 nmol/L indicates Ovulation.; Level <5 nmol/L suggests Ovulation did not occur.	Up to 4 weeks from starting treatment.	Yes
Secondary	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 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.	No
Secondary	Endometrial thickness and quality in the pre-ovulatory period.	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.	No
Secondary	Number of growing follicles detected by transvaginal ultrasound.	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.	Yes
Secondary	Pregnancy rate both clinical and biochemical.	Transvaginal ultrasound done to: 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.; Detect gestational and fetal pulsation.	Up to 8 weeks from starting treatment.	No
Secondary	Patient compliance.	Asking the participant about the empty strips.	Up to 4 weeks from starting treatment.	Yes
Secondary	Adverse effects: such as headache, nausea, vomiting, breast tenderness, blurred vision, and ovarian enlargement or hyperstimulation.	Asking the participant if there are any complaints about the side effects of the drugs.	Up to 4 weeks from starting treatment.	Yes