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Letrozole step-up protocol: the effect of a noval superovualtion induction protocol to enhance pregnancy rate in a couple with unexplained infertility undergoing intrauterine inssemination.

Letrozole step-up protocol: the effect of a noval superovualtion induction protocol to enhance pregnancy rate in a couple with unexplained infertility undergoing intrauterine inssemination.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000024640
Enrollment
100
Registered
2014-01-09
Start date
2014-01-14
Completion date
2014-04-15
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

new protocol of a medication can be used orally to enhance pregnancy rate in intrauterine insemination procedures with a lower cost .

Interventions

prospective randomized trial that included 100 couples with unexplained infertility agreed to continue with intrauterine inssemination (IUI ) All participants were extensively counseled about the risks and benefits of each type of treatment and an informed consent was obtained. 50 Patients received a daily dose of letrozole (Femara; Novartis) tablets orally beginning on day 3 of menstrual cycle with 2.5 mg (1 tab) which is then increased in a step up fashion to 5 mg (2 tabs), 7.5 mg (3 tabs)

prospective randomized trial that included 100 couples with unexplained infertility agreed to continue with intrauterine inssemination (IUI ) All participants were extensively counseled about the risks and benefits of each type of treatment and an informed consent was obtained. 50 Patients received a daily dose of letrozole (Femara; Novartis) tablets orally beginning on day 3 of menstrual cycle with 2.5 mg (1 tab) which is then increased in a step up fashion to 5 mg (2 tabs), 7.5 mg (3 tabs) and finally 10 mg (4 tabs) on days 4, 5 and 6 of the menstrual cycle (Total duration of treatment will be four days starting from third day of mensis). all participants of this group will be followed up by transvaginal ultrasonography starting from day 7 menstrual cycle every 3 days until one dominant follicle reaches a size of 17 mm hence HCG will be given intramuscular in a dose of 10000 iu followed by IUI 36 hours later .

Sponsors

alexandria university , faculty of medicine
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
20 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

couples with unexplained infertility All men had to have a normal semen analysis according to World Health Organization (WHO) criteria age from 20-35 years. Bilateral tubal patency . indicated and Consenting to do IUI .

Exclusion criteria

previous history of pelvic surgery endometriosis, females with a previous history of failed iui

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026