Study on Vaginal Progesterone for Improving Live Birth Rates in Women with Infertility Undergoing Frozen/Thawed IVF Natural Cycles

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What is this study about?

This clinical trial is focused on studying infertility, a condition where individuals have difficulty getting pregnant. The study is investigating the use of vaginal progesterone as a treatment to support the luteal phase, which is a part of the menstrual cycle that occurs after ovulation. The trial aims to determine if using vaginal progesterone can improve the chances of a live birth for women undergoing a specific type of fertility treatment called frozen/thawed in-vitro fertilization natural cycles (FET-NC). Two forms of progesterone are being used in this study: Cyclogest 400 mg vagitorium and Lutinus 100 mg vaginaltabletter.

The purpose of the study is to see if providing luteal phase support with vaginal progesterone is better than not providing any support, in terms of achieving a live birth. If it is found to be beneficial, the study will also compare whether a 7-week treatment is more effective than a 3-week treatment. Participants in the study will receive either the progesterone treatment or a placebo, and their progress will be monitored over time to assess various outcomes related to pregnancy and birth.

Throughout the study, researchers will track several outcomes, including live birth rates, pregnancy progression, and any complications that may arise during pregnancy. The study will also look at the cost-effectiveness of the treatment and measure progesterone levels in blood samples. The trial is expected to continue until early 2026, with the goal of providing valuable insights into the effectiveness of vaginal progesterone in supporting successful pregnancies for those experiencing infertility.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, body mass index (BMI), regular menstrual cycles, and language proficiency.

Informed consent is required to participate in the study.

2 treatment initiation

The study involves the use of vaginal progesterone as luteal support during frozen/thawed in-vitro fertilization natural cycles.

Participants are randomly assigned to receive either no luteal phase support or vaginal progesterone treatment.

3 medication administration

If assigned to the progesterone group, participants will use either Cyclogest 400 mg pessary or Lutinus 100 mg vaginal tablet.

The medication is administered through vaginal use.

4 treatment duration

The study aims to determine if 7 weeks of progesterone treatment is more effective than 3 weeks.

Participants will follow the assigned treatment duration as part of the study protocol.

5 monitoring and follow-up

Throughout the study, various outcomes such as live birth, pregnancy status, and progesterone levels in blood samples will be monitored.

Participants will undergo regular check-ups to assess the progress and any potential side effects.

6 study completion

The study is estimated to conclude by January 31, 2026.

Final assessments will be conducted to evaluate the effectiveness of the treatment in improving live birth rates.

Who Can Join the Study?

  • Planned for a FET-NC with a blastocyst. FET-NC stands for Frozen Embryo Transfer in a Natural Cycle, which is a process where a frozen embryo is placed in the uterus during a natural menstrual cycle.
  • Age between 18 and 42 years old.
  • BMI between 18.5 and 34.9. BMI stands for Body Mass Index, which is a measure of body fat based on height and weight.
  • Regular menstrual cycles lasting between 24 and 35 days.
  • Have given informed consent, meaning you agree to participate after understanding the study details.
  • Ability to understand written and spoken Swedish, English, or Arabic.

Who Cannot Join the Study?

  • Individuals who are not experiencing infertility cannot participate. Infertility means having difficulty getting pregnant.
  • Participants must be women, as men are not included in this study.
  • Participants must not belong to a vulnerable population. A vulnerable population includes groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Region Oestergoetland Linkoping Sweden
Region Oerebro Laen Orebro Sweden
Region Skane Skanes Universitetssjukhus Lund Sweden
Karolinska University Hospital Solna Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Livio Fertilitetscentrum AB Göteborg Gothenburg Sweden
Lkrlm Uvkm Umea Sweden
Iwghupsrmmz vwn Sotexmqljrzw Av Stockholm Sweden
Lbyri Fwkbz Ah Falun Sweden
Nipbhv Idd Sfonxra An Stockholm Sweden

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

Trial status

Country Status Recruitment Start
Iceland Iceland
Not recruiting
21.04.2021
Sweden Sweden
Not recruiting
21.04.2021

Trial locations

Investigated drugs:

Vaginal Progesterone is used in this trial as a form of luteal phase support. It is administered to women undergoing frozen/thawed in-vitro fertilization natural cycles (FET-NC) to see if it improves the chances of a live birth. The study aims to determine if using vaginal progesterone is better than not using any luteal phase support. Additionally, the trial seeks to find out if a longer duration of progesterone treatment (7 weeks) is more effective than a shorter duration (3 weeks).

Investigated diseases:

Infertility – Infertility is a condition where an individual or couple is unable to conceive a child after a year of regular, unprotected sexual intercourse. It can affect both men and women and may result from various factors, including hormonal imbalances, structural issues, or lifestyle factors. In women, infertility may be due to problems with ovulation, fallopian tubes, or the uterus. In men, it often involves issues with sperm production or function. The condition can be temporary or permanent, depending on the underlying cause. Infertility can lead to emotional stress and may require medical intervention to achieve pregnancy.

Trial ID:
2024-512844-40-00
Protocol code:
ProFET
Trial Phase:
Therapeutic confirmatory (Phase III)

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