Stimulated Versus Un-stimulated Intrauterine Insemination Cycles in Couples With Mild Male Factor Infertility

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT02469805
• Date of registration: 09/06/2015
• Prospective Registration: No
• Primary sponsor: Cairo University
• Public title: Stimulated Versus Un-stimulated Intrauterine Insemination Cycles in Couples With Mild Male Factor Infertility
• Scientific title: Stimulated Versus Un-stimulated Intrauterine Insemination Cycles in Couples With Mild Male Factor Infertility: A Randomized Controlled Trial
• Date of first enrolment: June 2015
• Target sample size: 450
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02469805
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Egypt

Key inclusion & exclusion criteria

Inclusion Criteria:

- Mild male factor infertility defined as meaning two or more semen analyses that have
one or more variables which fall below the 5th centile as defined by the World Health
Organization, and where the effect on the chance of pregnancy occurring naturally
through vaginal intercourse within a period of 24 months would then be similar to
people with unexplained infertility or mild endometriosis.

Exclusion Criteria:

- Known allergy to FSH

- Other factors of infertility.



Age minimum: 20 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Subfertility

Intervention(s)

Device: Shepherd catheter

Procedure: IUI

Drug: Merional

Procedure: Ovulation detection

Drug: Choriomon

Primary Outcome(s)

Ongoing pregnancy rate [Time Frame: 12 weeks after IUI or timed sexual intercourse]

Secondary ID(s)

sub 12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors