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

NCT03549741 | Unknown Phase 2

• 1 other identifier: CabCC
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• The number of mature follicles

  the follicles reach the size of 18 mm

  14 days

Study Arms (2)

study group

EXPERIMENTAL

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; Drug: Cabergoline Oral Tablet

control group

ACTIVE COMPARATOR

will receive a dose of Clomiphene citrate and placebo tablets with same dose and duration

Drug: Clomiphene Citrate 50mg; Drug: Placebo Oral Tablet

Interventions

Clomiphene Citrate 50mg DRUG

oral tablets

control group; study group

Cabergoline Oral Tablet DRUG

oral tablets

study group

Placebo Oral Tablet DRUG

oral tablets

control group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Infertility

Interventions

Clomiphene; Cabergoline

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 26, 2018
• First Posted: June 8, 2018
• Study Start: July 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: November 1, 2019
• Last Updated: June 8, 2018

Record last verified: 2018-05