An interventional study of letrozole in Infertility and Intrauterine Insemination, sponsored by Peking University Third Hospital. Completed at 1 site in China. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-02-08.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment
Among 31 studies testing letrozole in Infertility — 2 open to participants now, 3 under way, 2 of them phase 3. Letrozole · Infertility.
Among the 31 studies testing letrozole in Infertility, this one is the 19th largest by enrollment, is one of 3 that started in 2018, is one of 10 with no phase, and was the 24th registered.
2,087 studies on the registry are indexed under Infertility; 355 are open to participants now.
Browse Infertility studies →2 of the 31 studies testing letrozole in Infertility are open now, in 2 countries. Recruiting first, the newest first:
Peking University Third Hospital · Sites in China
Ages 20+ · Women only
University of California, San Francisco · Sites in United States
Ages 18–50 · Women only
By country, each count listing its studies:
Letrozole: first FDA approval 1997 (FEMARA). What it is approved for, and how studies give it, is on its page →
Of the 233 Infertility studies recruiting now, 43 (18%) set no upper age limit and 184 (79%) stop at 75 or younger; 27 take children under 18; 76 take healthy volunteers.
This study: 20 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
31 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 4 · Phase 3 13 · Phase 4 6
First in 2004; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 100 is below the median of 134 across 1,413 interventional studies indexed under Infertility.
Median enrollment 131 across the 31 interventional studies. Of the 18 that completed or were terminated, 4 (22%) have results posted.
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2 of 31 have an industry lead sponsor. The 10 most frequent:
Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.
12 studies in Infertility by Peking University Third Hospital: 3 open now, 3 under way, none of them phase 3. Of 2 finished, 0 (0%) have results posted.
Among the 12 studies in Infertility by Peking University Third Hospital, this one is the 9th largest by enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2018, is one of 6 with no phase, and was the 2nd registered.
Peking University Third Hospital’s Infertility studies by the year they started, since 2009.
None of the studies under way reaches primary completion within a year.
Among the 31 studies testing letrozole in Infertility, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Peking University Third Hospital’s 12 in Infertility:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
letrozole 5mg/day starting from day 3 of menstrual cycle for 5 days
Drug: letrozole
Women will be randomizedfor ovarian stimulation with letrozole or to natural cycle IUI.
ongoing pregnancy
Primary outcome is ongoing pregnancy leading to live birth
Time frame: 3 months
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Jun 2019, 15 months.
Of 386 non-industry interventional studies with no phase under Infertility, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 15 months is below that.
Counting every sponsor, half of 417 studies reached it within 24 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Letrozole
Peking University Third Hospital →