• Intrauterine Insemination and Luteal Fase Support

  NCT01826747

  CompletedInterventionalPhase 4Updated Oct 19, 2018
• Luteal Phase Progesterone in IUI and Gonadotropin Cycles

  NCT01941875

  CompletedInterventionalPhase 3Updated Jul 18, 2022
• Luteal Phase Support With Progesterone Versus Estrogen and Progesterone on Pregnancy Rates

  NCT01237535

  Unknown statusInterventionalPhase 4Updated Nov 9, 2010
• Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support

  NCT02316626

  CompletedInterventionalPhase 4Updated Nov 22, 2016
• Progesterone Luteal Support in Unexplained Infertility Management

  NCT07738068

  Not yet recruitingInterventionalPhase 3Updated Jul 30, 2026
• Intrauterine Insemination With Letrozole Versus in Natural Cycle

  NCT03455426

  CompletedInterventionalNot ApplicableUpdated Feb 8, 2021

ClinicalTrials.gov ID

NCT07508657

Lead Sponsor

Kirstine KirkegaardOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

690Estimated

Last Update Posted

Apr 2, 2026Actual

Start Date

Apr 2026Estimated

Primary Completion Date

Jun 2029Estimated

Completion Date

Jan 2030Estimated

Official Title

Luteal Phase Support Following Letrozole Treatment in Women Undergoing Intrauterine Insemination: a Multicenter Randomized Trial

Brief Summary

This trial aims to investigate whether luteal phase support improves the chance of pregnancy in women undergoing intrauterine insemination (IUI) following ovarian stimulation with letrozole.

In this randomized clinical trial, 690 women undergoing letrozole-stimulated IUI at four public fertility clinics in Denmark will be randomly allocated to one of two groups:

• Vaginal progesterone from the day after insemination (Cyclogest 400 mg twice daily)
• No luteal phase support, reflecting current clinical practice

All participants will undergo a standard letrozole-stimulated IUI treatment, including ultrasound monitoring, ovulation triggering, and insemination. Blood samples will be collected on the day of insemination and 7-9 days after insemination to measure hormone levels.

The results of this trial will provide further insight into the role of progesterone support in letrozole-stimulated IUI cycles.

• Infertility

• Progesterone

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Age 18-37 years
• Scheduled for IUI with homologous or donor sperm
• Undergoing mild ovarian stimulation with letrozole
• Ability to provide written informed consent

Exclusion Criteria:

• Age > 37 years
• Anovulation due to hypogonadotropic hypogonadism
• Known hypersensitivity to progesterone or hard fat listed as an excipient in the Summary of Product Characteristics (SmPC) for Cyclogest.
• Known or suspected progesterone-sensitive malignant tumours
• Porphyria
• Known missed abortion or ectopic pregnancy
• Active arterial or venous thromboembolism, severe thrombophlebitis, or a history of these conditions
• Severe hepatic dysfunction or liver disease
• Inability to speak or understand Danish sufficiently to comprehend oral and written study information

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Kirstine KirkegaardOTHER

HEH-gynaekologisk-obstetrisk.afdeling.g@regionh.dk+4538683868