Rectally administered micronized progesterone for luteal phase support in hormone replacement therapy frozen embryo transfer (HRT-FET) cycle – non-inferiority randomized controlled trial

Phase 1

Conditions: Infertility
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Registration Number: CTIS2023-504616-15-00

Lead Sponsor: Region Midtjylland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 618

Inclusion Criteria

18-46 years, BMI >18.5 <34 kg/m², Day 5 vitrified blastocyst available for transfer after thawing, Speaking and understanding Danish

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Secondary end-points are positive hCG rate, clinical pregnancy, pregnancy loss, LBR, mean P4 levels in Group B (study group) and the relation to OPR. Urine progesterone levels in the two groups and the relation to OPR. Side effects and patient convenience regarding rectally administration of Cyclogest. Complications during the pregnancy e.g. hypertension and preeclampsia.;Primary end point(s): Ongoing pregnancy rate week 12 after HRT-FET with rectally administered progesterone, only.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Positive hCG rate,;Secondary end point(s):Clinical pregnancy,;Secondary end point(s):Pregnancy loss,;Secondary end point(s):LBR,;Secondary end point(s):Mean P4 levels in Group B (study group) and the relation to OPR.;Secondary end point(s):Urine progesterone levels in the two groups and the relation to OPR.;Secondary end point(s):Side effects and patient convenience regarding rectally administration of Cyclogest.;Secondary end point(s):Complications during the pregnancy e.g. hypertension and preeclampsia.