Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: PCOS

Treatments: Drug: Clomiphene citrate; Drug: Clomiphene citrate placebo; Drug: Tamoxifen; Drug: Tamoxifen Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02479256

20092009

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 2 patient groups

Clomiphene citrate + placebo

Experimental group

Description:

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.

Treatment:

Drug: Tamoxifen Placebo

Drug: Clomiphene citrate

Tamoxifen + placebo

Experimental group

Description:

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.

Treatment:

Drug: Tamoxifen

Drug: Clomiphene citrate placebo