NCT03455426

Intrauterine Insemination With Letrozole Versus in Natural Cycle

Completed NA Last updated 8 February 2021

What this trial tests

NA trial testing letrozole in Infertility in 100 participants. Completed in 31 December 2019.

Timeline

15 March 2018

Primary endpoint
30 June 2019

31 December 2019

Quick facts

Lead sponsor	Peking University Third Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	15 March 2018
Primary completion	30 June 2019
Estimated completion	31 December 2019
Sites	1 location across China

Drugs / interventions tested

• letrozole — full drug profile →

Conditions studied

• Infertility — all drugs for Infertility →
• Intrauterine Insemination — all drugs for Intrauterine Insemination →

Sponsor

Peking University Third Hospital

Who can join

20 and older, female only, with Infertility or Intrauterine Insemination. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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, 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 natural cycle treatment.

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for unexplained infertility: a systematic review and network meta-analysis.
   Wang R, Danhof NA, Tjon-Kon-Fat RI, Eijkemans MJ, et al · · 2019 · cited 30× · PMID 31486548 · DOI 10.1002/14651858.cd012692.pub2
2. Intra-uterine insemination for unexplained subfertility.
   Ayeleke RO, Asseler JD, Cohlen BJ, Veltman-Verhulst SM. · · 2020 · cited 28× · PMID 32124980 · DOI 10.1002/14651858.cd001838.pub6
3. Intrauterine insemination (IUI) with or without letrozole for unexplained or mild male factor infertility: A randomized pilot study.
   Huang S, Wang R, Yan H, Li N, et al · · 2021 · cited 2× · PMID 34062308 · DOI 10.1016/j.ejogrb.2021.05.029