Progesterone Supplementation After Letrozole-stimulated Insemination

Condition(s) studied

Investigational drug(s) / intervention(s)

Progesterone: Vaginal progesterone (Cyclogest) 400 mg administered twice daily starting the day after insemination. Treatment is continued until gestational age 10 weeks in the event of clinical pregnancy or until clinical pregnancy is ruled out.

Study 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.

Eligibility

Primary outcome measure(s)

• Clinical Pregnancy Rate — Gestational age 7-9 weeks
  Defined as an ultrasonographically visible foetal heartbeat at 7-9 weeks of gestation

Trial sites (4)

Other trials for the same condition