A study of progesterone after letrozole treatment for women with infertility undergoing intrauterine insemination

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What is this study about?

This study focuses on Infertility, a condition where a person has difficulty conceiving a child. The research involves women who have undergone intrauterine insemination, a procedure where sperm is placed directly inside the uterus to help with fertilization, following treatment with letrozole, a medication used to stimulate the ovaries. The main goal is to determine if adding progesterone, a hormone that helps prepare the lining of the uterus for pregnancy, can improve the chances of a successful pregnancy.

Participants in the study may receive either Cyclogest, which is a form of progesterone delivered as a pessary through vaginal use, or a placebo. The luteal phase refers to the period in the menstrual cycle after ovulation occurs and before the next period begins, a time when hormone levels are critical for supporting a developing pregnancy. By comparing these two groups, the study aims to see how supplementation affects outcomes such as pregnancy rates and various health factors during pregnancy and birth.

Who Can Join the Study?

  • You must be between 18 and 37 years old.
  • You are planning to undergo intrauterine insemination, which is a procedure where sperm is placed directly inside the uterus to help with pregnancy.
  • The sperm used can be from a partner or a donor, which is a person who provides sperm for reproductive purposes.
  • You must be receiving mild ovarian stimulation, a process using medication to encourage the ovaries to produce eggs.
  • The medication used for this stimulation must be letrozole.
  • You must be able to provide written informed consent, which means you understand the study and sign a document agreeing to participate.

Who Cannot Join the Study?

  • Being older than 37 years of age.
  • Not ovulating (not releasing an egg) because of hypogonadotropic hypogonadism, which is a condition where the brain does not send enough signals to the ovaries to trigger ovulation.
  • Having a known hypersensitivity, or an allergic reaction, to progesterone or to hard fat, which are ingredients used in the study medication.
  • Having or suspected having malignant tumours (cancer) that are sensitive to progesterone.
  • Having porphyria, which is a group of rare genetic disorders that affect the production of certain chemicals in the body.
  • A known history of missed abortion (when a pregnancy ends but the body does not immediately show signs) or ectopic pregnancy (when a fertilized egg grows outside the main area of the womb).
  • Having an active thromboembolism, which is a blood clot in an artery or vein, thrombophlebitis, which is inflammation of a vein caused by a blood clot, or having a history of these conditions.
  • Having severe hepatic dysfunction, which means the liver is not working properly, or having liver disease.
  • Being unable to speak or understand Danish well enough to understand all the written and spoken information about the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Hawkds Hlgnvpdd Herlev Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not yet recruiting
02.02.2026

Trial locations

Investigated drugs:

Progesterone is a hormone used as a supplement to support the lining of the uterus, which helps in the possibility of a successful pregnancy.

Infertility – This condition occurs when a person or couple is unable to achieve pregnancy after regular, unprotected sexual intercourse. It can involve difficulties with ovulation, the health of the reproductive organs, or issues with sperm quality. The process may progress as a persistent inability to conceive over several months. It often stems from hormonal imbalances or physical obstructions within the reproductive system.

Trial ID:
2025-524327-53-00
Protocol code:
LIFT
Trial Phase:
Therapeutic confirmatory (Phase III)

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