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Rectally administered micronized progesterone for luteal phase support in hormone replacement therapy frozen embryo transfer (HRT-FET) cycle – non-inferiority randomized controlled trial
EU CTIS ID: 2023-504616-15-00
What this study is testing
The aim of this study is to investigate the ongoing pregnancy rate (OPR) week 12 in HRT-FET cycles after rectally administered progesterone as the only administered progesterone and is there a non-inferior different to vaginal LPS in HRT-FET cycles. Furthermore, what is the optimal serum P4 level after rectally micronized progesterone administration in HRT-FET.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18-46 years
- BMI >18.5 <34 kg/m²
- Day 5 vitrified blastocyst available for transfer after thawing
- Speaking and understanding Danish
You likely can't join if
- Has a contraindication or history to Cyclogest or components there of; or has a history of drug or allergy that, in the opinion of the investigator contraindicates study participation.
- Violation of the protocol.
- Inflammatory bowel disease (Colitis ulcerosa and Mb. Crohn),
- Endometrium <7 mm after 12-20 days of 6 mg estradiol treatment.
- Previous enrolment in the trial.
- No blastocyst for transfer.
See the full eligibility criteria
- 18-46 years
- BMI >18.5 <34 kg/m²
- Day 5 vitrified blastocyst available for transfer after thawing
- Speaking and understanding Danish
- Has a contraindication or history to Cyclogest or components there of; or has a history of drug or allergy that, in the opinion of the investigator contraindicates study participation.
- Violation of the protocol.
- Inflammatory bowel disease (Colitis ulcerosa and Mb. Crohn),
- Endometrium <7 mm after 12-20 days of 6 mg estradiol treatment.
- Previous enrolment in the trial.
- No blastocyst for transfer.
- Uterine abnormalities
- Oocyte donation.
- Dysregulated severe chronical medical diseases.
- Patients who are treated with medication metabolized by CYP3A4 enzymes.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.