Intrauterine Insemination With Letrozole Versus in Natural Cycle

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

IUI With Letrozole Versus in Natural Cycle

NCT04169451

Intrauterine Insemination Unexplained Infertility

RECRUITING NA

Effect of Gonadotropin Types and Indications on Homologous Intrauterine Insemination Success

NCT03669276

Infertility

COMPLETED

Only Gonadotropin Vs. Letrozole Combined Gonadotropin Stimulation in IUI Cycles

NCT06413771

Infertility Unexplained

COMPLETED NA

Luteal Phase Progesterone in IUI and Gonadotropin Cycles

NCT01941875

Infertility

COMPLETED PHASE3

The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET)

NCT06006091

Letrozole Infertility, Female

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility Intrauterine Insemination

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

letrozole group

letrozole 5mg/day starting from day 3 of menstrual cycle for 5 days

Group Type EXPERIMENTAL

letrozole

Intervention Type DRUG

Women will be randomizedfor ovarian stimulation with letrozole or to natural cycle IUI.

natural cycle group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

letrozole

Women will be randomizedfor ovarian stimulation with letrozole or to natural cycle IUI.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Being diagnosed with unexplained or mild male subfertility
* At least one sided tubal patency, established according to local protocol
* Normal or mild impairment of semen quality defined as a TMSC of 3 million or more based on at least one semen analysis

Exclusion Criteria

* Woman with double sided tubal pathology
* Women with irregular cycles, PCOS or other endocrine disorders
* Impaired semen quality: pre-wash TMSC \<3 million.

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No