Intrauterine Insemination With Letrozole Versus in Natural Cycle

NCT03455426 | Completed

• 1 other identifier: IUI-letrozole/natural cycle
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Infertility; Intrauterine Insemination

Outcome Measures

Primary Outcomes (1)

• ongoing pregnancy

  Primary outcome is ongoing pregnancy leading to live birth

  3 months

Study Arms (2)

letrozole group

EXPERIMENTAL

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

Drug: letrozole

natural cycle group

NO INTERVENTION

Interventions

letrozole DRUG

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

letrozole group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (1)

• Franik S, Le QK, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for ovulation induction in infertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2022 Sep 27;9(9):CD010287. doi: 10.1002/14651858.CD010287.pub4.

  PMID: 36165742 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shuo Huang, PhD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2018
• First Posted: March 6, 2018
• Study Start: March 15, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: February 8, 2021

Record last verified: 2019-07

Locations

CN (1)