Vaginal progesterone as luteal support for improvement of live birth in frozen/thawed in-vitro fertilization natural cycles; a multicenter, open, randomized trial
- Conditions
- infertilityTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2020-005552-38-SE
- Lead Sponsor
- Västragötalandsregionen, Sahlgrenska Universitetssjukhuset
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1800
•Planned for a FET-NC
•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
•FET of blastocyst
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1800
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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.
•Drugrelated: 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 Main Objective: 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. ;Secondary Objective: -To compare treatment groups regarding:<br>1. Pregnancy outcomes including biochemical, clinical, ongoing and term pregnancy rates, as well as rates of miscarriage, termination of pregnancy and ectopic pregnancy.<br>2. Perinatal and obstetric outcomes.<br>3. Self-reported side effects and adverse events <br>4. Cost effectiveness.<br>-To analyze the effect of S-progesterone level before FET on the chance of achieving live birth and secondary pregnancy outcomes.<br>;Primary end point(s): Live birth;Timepoint(s) of evaluation of this end point: Time point of delivery
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Biochemical pregnancy, clinical pregnancy, ongoing pregnancy, term pregnancy, miscarriage, ectopic pregnancy, termination of pregnancy, intrauterine fetal death, perinatal death.<br>Perinatal outcomes: birth weight, gestational age, preterm birth (PTB), very PTB, low birth weight (LBW), very LBW, stillbirth, perinatal death (stillbirth+early neonatal death), birth defects detected at birth.<br>Obstetric outcomes: hypertensive disorders of pregnancy (gestational hypertension and pre-eclampsia) (HDP), placenta previa, placenta abruption, postpartum hemorrhage (PPH)<br>Cost-effectiveness analysis (will be described in a separate study protocol later)<br>Progesterone levels in blood samples from day LH+3 will be measured and used as covariate in the analyses. <br>;Timepoint(s) of evaluation of this end point: From 12 Days after frozen embryo transfer (FET) until one week after delivery