Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility

Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility: Randomized Controlled Trial

Infertility refers to an inability to conceive after having regular unprotected sex. Infertility can also refer to the biological inability of an individual to contribute to conception, or to a female who cannot carry a pregnancy to full term. In many countries infertility refers to a couple that has failed to conceive after 12 months of regular sexual intercourse

Study Overview

• Status: Unknown
• Conditions: Infertility
• Intervention / Treatment: Drug: Clomiphene Citrate 50mg; Drug: Cabergoline Oral Tablet; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• unexplained infertility, Primary or secondary.
• Absence of galactorrhoea.
• Normal serum prolactin.
• Normal hysterosalpingography.
• Normal spermogram.

Exclusion Criteria:

• Women on other line of treatment as aromatase inhibitors,gonadotrophins, or tamoxifen.
• Known hypersensitivity for cabergoline or clomiphene citrate.
• Other factors of infertility as tubal factor, uterine factor or male factor.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; will receive a dose of Clomiphene citrate 50 mg tablet , 1 tab twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package) first three months then Clomiphene citrate 50 mg tablet , 2 tabs twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package)	Drug: Clomiphene Citrate 50mg; oral tablets; Drug: Cabergoline Oral Tablet; oral tablets
Active Comparator: control group; will receive a dose of Clomiphene citrate and placebo tablets with same dose and duration	Drug: Clomiphene Citrate 50mg; oral tablets; Drug: Placebo Oral Tablet; oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of mature follicles	the follicles reach the size of 18 mm	14 days

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: May 26, 2018
• First Submitted That Met QC Criteria: May 26, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): June 8, 2018
• Last Update Submitted That Met QC Criteria: May 26, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Dopamine Agonists; Dopamine Agents; Hormone Antagonists; Estrogen Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Antiparkinson Agents; Anti-Dyskinesia Agents; Clomiphene; Enclomiphene; Zuclomiphene; Cabergoline
• Other Study ID Numbers: CabCC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No