Clinical trial NCT02479256: Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs
Official title: Clomiphene Citrate Versus Tamoxifen for Induction of Ovulation in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PCOS
Keywords: PCOS
Induction of ovulation
Clomiphene citrate
Tamoxifen
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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 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.

Primary outcomes:
measure: Rate of ovulation.
timeFrame: Up to 4 weeks from starting treatment.
Secondary outcomes:
measure: 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.
timeFrame: Up to 4 weeks from starting treatment.
measure: Endometrial thickness and quality in the pre-ovulatory period.
timeFrame: Up to 4 weeks from starting treatment.
measure: Number of growing follicles detected by transvaginal ultrasound.
timeFrame: Up to 4 weeks from starting treatment.
measure: Pregnancy rate both clinical and biochemical.
timeFrame: Up to 8 weeks from starting treatment.
measure: Patient compliance.
timeFrame: Up to 4 weeks from starting treatment.
measure: Adverse effects: such as headache, nausea, vomiting, breast tenderness, blurred vision, and ovarian enlargement or hyperstimulation.
timeFrame: Up to 4 weeks from starting treatment.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
affiliation: Professor of Obstetrics and Gynaecology, Ain Shams University
name: Gasser M. El-Bishry, FRCOG
role: STUDY_DIRECTOR
affiliation: Assistant professor of Obstetrics and Gynaecology, Ain Shams University
name: Abdel-Latif G. El-Kholy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Obstetrics and Gynaecology, Ain Shams University
name: Mohamed S. Sweed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Resident of Obstetrics and Gynaecology
name: Diana N. Kolta, MB BCh
role: PRINCIPAL_INVESTIGATOR
References: