Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs

NCT02479256 | Completed Phase 4 DMC

• 1 other identifier: 20092009
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PCOS

Keywords

PCOS; Induction of ovulation; Clomiphene citrate; Tamoxifen

Outcome Measures

Primary Outcomes (1)

• 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: 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 Outcomes (6)

• 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.

  Up to 4 weeks from starting treatment.

• Endometrial thickness and quality in the pre-ovulatory period.

  Up to 4 weeks from starting treatment.

• Number of growing follicles detected by transvaginal ultrasound.

  Up to 4 weeks from starting treatment.

• Pregnancy rate both clinical and biochemical.

  Up to 8 weeks from starting treatment.

• Patient compliance.

  Up to 4 weeks from starting treatment.

Study Arms (2)

Clomiphene citrate + placebo

EXPERIMENTAL

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; Drug: Tamoxifen Placebo

Tamoxifen + placebo

EXPERIMENTAL

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; Drug: Clomiphene citrate placebo

Interventions

Clomiphene citrate DRUG

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.

Also known as: Clomid

Clomiphene citrate + placebo

Tamoxifen Placebo DRUG

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.

Clomiphene citrate + placebo

Tamoxifen DRUG

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.

Tamoxifen + placebo

Clomiphene citrate placebo DRUG

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.

Tamoxifen + placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary infertility.
• Body mass index (BMI) between 25 and 30 Kg/m 2.
• Polycystic ovary syndrome (using ESHRE/ASRM criteria).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Interventions

Clomiphene; Tamoxifen

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gasser M. El-Bishry, FRCOG

  Professor of Obstetrics and Gynaecology, Ain Shams University

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: June 24, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

EG (1)