Intrauterine Insemination With Letrozole Versus Without Stimulation
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Rationale: Intrauterine insemination (IUI) is the treatment of first choice for couples with
unexplained and mild male factor infertility in many countries, but it is controversial
whether ovarian stimulation improves fertility outcomes. In recent retrospectively collected
data and results from a pilot study, investigators found that in couples with unexplained and
mild male factor infertility undergoing IUI, ovarian stimulation with letrozole increased
live birth rate as compared to natural cycle IUI without substantially increasing the
multiple pregnancy rate. Investigators therefore perform a randomized clinical trial (RCT) on
the subject in the Centre of Reproductive Medicine, Peking University Third Hospital,
Beijing, China.
Objective: To test the hypothesis that in couples with unexplained or mild male factor
infertility scheduled for an IUI program ovarian stimulation with letrozole increases the
live birth rate as compared to IUI without stimulation.
Study design Randomized clinical trial. Study population Women diagnosed with unexplained or
mild male factor infertility scheduled for treatment with IUI.
Intervention Women will be randomized for ovarian stimulation with letrozole or to natural
cycle IUI. In the group allocated to ovarian stimulation, women will receive oral tablets
letrozole 5 mg daily from cycle day 3-5 for 5 days. Investigators will treat the couples for
3 cycles, with a time horizon of 4 months.
Main study parameters/endpoints Primary outcome is ongoing pregnancy leading to live birth.
Secondary endpoints are clinical pregnancy, multiple pregnancy, miscarriage rates, pregnancy
complications and patients' costs.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness The strategies compared are already broadly applied in current practice. No
additional risks are expected. There is no benefit for participants, but the results may
benefit future subfertile couples.