Study on the Effectiveness of Vaginal Micronized Progesterone for Infertility in Patients Undergoing Assisted Conception with Frozen Embryo Transfer (AC-FET)

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What is this study about?

This clinical trial is focused on studying infertility and involves the use of two different formulations of vaginal micronized progesterone. The purpose of the study is to compare the effectiveness, safety, and comfort of these two formulations in supporting pregnancy during a specific phase called the luteal phase, which is important for maintaining a pregnancy. The study is designed for patients who are undergoing a process known as artificial cycle-frozen embryo transfer (AC-FET), which is a part of fertility treatment where embryos are transferred to the uterus after being frozen and thawed.

Participants in the study will receive either a standard formulation of micronized progesterone at a dose of 200 mg taken three times a day or a new formulation at a dose of 400 mg taken twice a day. The study will last for a period of time during which participants will be monitored for ongoing pregnancy rates, which is the main focus of the study. Other aspects being observed include the rate of embryo implantation, biochemical pregnancy rates (which are early signs of pregnancy detected through blood tests), clinical pregnancy rates (confirmed by ultrasound), and any occurrences of miscarriage. The study will also track any side effects experienced by participants.

The trial aims to provide valuable information on which formulation of micronized progesterone is more effective and better tolerated by patients undergoing fertility treatments. This information could help improve treatment options for individuals experiencing infertility. Participants will be required to attend regular appointments for blood tests and medication distribution as part of the study process.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, body mass index (BMI), and previous medical procedures like in vitro fertilization (IVF).

Participants must be able to attend appointments for blood tests and medication dispensation.

2 medication administration

Participants receive vaginal micronized progesterone for luteal phase support. Two formulations are compared: a standard formulation of 200 mg taken three times a day (tid) and a new formulation of 400 mg taken twice a day (bid).

The medication is administered via vaginal capsules.

3 monitoring and assessments

Regular monitoring includes blood tests and assessments to track the progress of the treatment.

The primary focus is on the ongoing pregnancy rate, with secondary assessments including implantation rate, biochemical pregnancy rate, clinical pregnancy rate, miscarriage rate, and frequency of adverse events.

4 completion of the trial

The trial is estimated to conclude by October 31, 2024.

Final assessments are conducted to evaluate the efficacy, safety, and tolerability of the two progesterone formulations.

Who Can Join the Study?

Patients must be undergoing an artificial cycle-frozen embryo transfer (AC-FET), which is a process where a frozen embryo is transferred to the uterus.
The lining of the uterus, called the endometrium, must be prepared using hormone replacement therapy.
Patients should be between the ages of 18 and 43 if they are using their own eggs from a previous IVF cycle (a process where eggs are fertilized outside the body), with or without genetic testing of the embryos.
Patients can be under 50 years old if they are using donated eggs.
The Body Mass Index (BMI), which is a measure of body fat based on height and weight, should be greater than 18 and less than 30.
The embryo being transferred should be at the blastocyst stage, which is a specific stage of embryo development.
Patients must be willing to participate in the study.
Patients must be able to visit the study center for necessary procedures like blood tests, appointments, and receiving medication.

Who Cannot Join the Study?

Patients who are not experiencing infertility cannot participate. Infertility means having difficulty getting pregnant.
Patients who are not female cannot participate. This study is only for women.
Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Hospital Universitari General De Catalunya	Sant Cugat Del Valles	Spain
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Hezewavu Qbxwwbnezpn Dca Vxlnjh	Sabadell	Spain
Dhvngo Mghvs Rnld	Reus Tarragona	Spain
Dyhazd Mwxbv Tclhtlhpu	Tarragona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.01.2023

Trial locations

Investigated drugs:

Vaginal Micronized Progesterone (Standard Formulation)
This medication is used to support the luteal phase in patients undergoing assisted reproductive technology procedures. It is a standard formulation of progesterone that is administered vaginally. The role of this medication in the trial is to help maintain a pregnancy by preparing the lining of the uterus to receive and support a fertilized egg.

Vaginal Micronized Progesterone (New Formulation)
This is a new formulation of vaginal micronized progesterone being tested in the trial. Like the standard formulation, it is used to support the luteal phase in patients undergoing assisted reproductive technology procedures. The trial aims to compare this new formulation with the standard one to see if it is more effective, safe, and tolerable in maintaining a pregnancy.

Investigated diseases:

Infertility

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 problems, or issues with sperm or egg production. In women, infertility can be related to ovulation disorders, blocked fallopian tubes, or uterine abnormalities. In men, it often involves low sperm count, poor sperm motility, or blockages that prevent sperm delivery. 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:

2024-513102-57-00

Protocol code:

FSD-MIC-2022-03

NCT ID:

NCT05899010

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Vaginal Micronized Progesterone for Infertility in Patients Undergoing Assisted Conception with Frozen Embryo Transfer (AC-FET)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?