Vaginal progesterone as luteal support for improvement of live birth in frozen/thawed in-vitro fertilization natural cycles; a multicenter, open, randomized trial.

Phase 4

Recruiting

• Conditions: Infertility

• Registration Number: 2024-512844-40-00
• Lead Sponsor: Vaestra Goetalandsregionen

Brief Summary

The primary objective is to investigate if luteal phase support by vaginal progesterone, is superior to no luteal phase support, in terms of live birth per woman undergoing FET-NC, and if superiority is shown, if 7 weeks of progesterone treatment is superior to 3 weeks treatment.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-06-26
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Female
• Target Recruitment: 1800

Inclusion Criteria

Planned for a FET-NC with a blastocyst

Age≥18<43 years

BMI≥18.5<35

Regular menstrual cycles 24-35 days

Given informed consent

Understand written and spoken Swedish, English or Arabic

Exclusion Criteria

ART-related: Oocyte donor cycles. Preimplantation Genetic Testing (PGT) cycles. Uterine malformation, precluding cervical access to the uterine cavity. Submucous myoma and endometrial polyps requiring surgery before transfer of embryo.

Drug-related: Hypersensitivity against study medication. Other contraindications according to FASS: Undiagnosed vaginal bleeding, severely impaired liver function or liver disease, known or suspected malignancy of breast or genital region, ongoing arterial or venous thromboembolism, porphyria or history of these conditions (FASS.se).

Development of serious disease contraindicating ART or pregnancy.

Participation or recent participation in a clinical study with an investigational product (during the past 30 days). Previous participation in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Live birth		Live birth

Secondary Outcome Measures

Name	Time	Method
Biochemical pregnancy, clinical pregnancy, ongoing pregnancy, term pregnancy, miscarriage, ectopic pregnancy, termination of pregnancy, intrauterine fetal death, perinatal death.		Biochemical pregnancy, clinical pregnancy, ongoing pregnancy, term pregnancy, miscarriage, ectopic pregnancy, termination of pregnancy, intrauterine fetal death, perinatal death.
Perinatal outcomes: birth weight, gestational age, preterm birth (PTB), very PTB, low birth weight (LBW), very LBW, stillbirth, perinatal death (stillbirth + early neonatal death = neonatal death <7 days), birth defects detected at birth.		Perinatal outcomes: birth weight, gestational age, preterm birth (PTB), very PTB, low birth weight (LBW), very LBW, stillbirth, perinatal death (stillbirth + early neonatal death = neonatal death <7 days), birth defects detected at birth.
Obstetric outcomes: hypertensive disorders of pregnancy (gestational hypertension and pre-eclampsia) (HDP), placenta previa, placenta abruption, postpartum hemorrhage (PPH).		Obstetric outcomes: hypertensive disorders of pregnancy (gestational hypertension and pre-eclampsia) (HDP), placenta previa, placenta abruption, postpartum hemorrhage (PPH).
Cost-effectiveness		Cost-effectiveness
Progesterone levels in blood samples from day LH+3		Progesterone levels in blood samples from day LH+3

Trial Locations

Locations (11)

Livio Reykjavik; 🇮🇸 Reykjavik, Iceland

Sahlgrenska University Hospital-Vaestra Goetalandsregionen; 🇸🇪 Goteborg, Sweden

Livio Umeå; 🇸🇪 Umeå, Sweden

Karolinska University Hospital; 🇸🇪 Huddinge, Sweden

Region Skane Skanes Universitetssjukhus; 🇸🇪 Malmo, Sweden

Region Oerebro Laen; 🇸🇪 Orebro, Sweden

Livio Fertilitetscentrum AB Göteborg; 🇸🇪 Göteborg, Sweden

IVF-gruppen vid Sophiahemmet AB; 🇸🇪 Stockholm, Sweden

Region Oestergoetland; 🇸🇪 Linkoping, Sweden

Livio Falun AB; 🇸🇪 Falun, Sweden

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Livio Reykjavik

🇮🇸Reykjavik, Iceland

Kristbjörg Heidur Olsen

Site contact

+3544304000

reykjavik@livio.is