MIcronized PROgesterone in Frozen Embryo Transfer Cycles
ConditionInfertility
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorFundación Santiago Dexeus Font
About this trial
This randomized trial was designed as non-inferiority trial aiming to compare ongoing pregnancy rates following LPS with 600 mg/day vs 800 mg/day vaginal VMP. All patients will undergo an artificial cycle frozen embryo transfer (AC-FET) with transdermal estradiol 6mg/day Patients undergoing an artificial cycle FET will start estrogen priming with transdermal estradiol 6mg/day (Estrogel®) on cycle D1-D3. Following 10-12 days of estrogen priming, patients will be randomized to luteal phase support with a standard formulation (200mg tid, Utrogestan®) or a new formulation (400mg bid) VMP. All patients will undergo a serum P measurement on the day before embryo transfer (ET). Patients with P\<10 ng/ml will receive a supplement of oral micronized progesterone 300mg, while patients with P≥10ng/ml will maintain the previous luteal phase support (LPS) protocol
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Endometrial preparation with hormone replacement therapy
Age 18-43 years following an autologous IVF cycle (with or without preimplantation genetic testing for aneuploidy)
Age < 50 years following an egg donation cycle
BMI > 18 and < 30 kg/m2
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Vaginal progesterone 600mg daily
DrugIf endometrial thickness (ETH) ≥7 mm and follicle dominance/ultrasound (US) signs of ovulation P levels are measured: if P ≤1.5 patients start LPS, else cycle is cancelled. If ETH \<7mm and no follicle dominance: estradiol dose is increased to 9mg/day and new US is performed up to 4 days after. If persistent thin endometrium after dose increase, cycle is cancelled. 24-48h pre ET, E2 and P are measured. in the morning, pre VMP dose, or at least 6h after last progesterone dose. If progesterone \<10ng/ml, additional 300mg daily oral micronized progesterone is administered on the day of the ET and maintained until 10 weeks pregnancy or up to menses or up to negative pregnancy test 10 days after ET. ET will be performed with available blastocysts 6 days after start of LPS. 3-5 days, after ET, a blood test for P measurement will be performed in the morning, before VMP dose, or at least 6h after last progesterone dose. 10 days after ET, the last P test will be done with pregnancy test.
Vaginal progesterone 800mg daily
DrugIf endometrial thickness (ETH) ≥7 mm and follicle dominance/ultrasound (US) signs of ovulation P levels are measured: if P ≤1.5 patients start LPS, else cycle is cancelled. If ETH \<7mm and no follicle dominance: estradiol dose is increased to 9mg/day and new US is performed up to 4 days after. If persistent thin endometrium after dose increase, cycle is cancelled. 24-48h pre ET, E2 and P are measured. in the morning, pre VMP dose, or at least 6h after last progesterone dose. If progesterone \<10ng/ml, additional 300mg daily oral micronized progesterone is administered on the day of the ET and maintained until 10 weeks pregnancy or up to menses or up to negative pregnancy test 10 days after ET. ET will be performed with available blastocysts 6 days after start of LPS. 3-5 days, after ET, a blood test for P measurement will be performed in the morning, before VMP dose, or at least 6h after last progesterone dose. 10 days after ET, the last P test will be done with pregnancy test.
Treatment groups
1,020 Participants
are divided into 2 treatment groupsGroup A: Vaginal progesterone 600mgActive comparator 1 intervention
Group B: Vaginal progesterone 800mgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Ongoing pregnancy rate
A positive heart beat at ultrasound after 11-13 weeks of gestation
Time frame
7-9 weeks after embryo transferSecondary outcomes
1
Implantation rate
Number of gestational sacs over total embryo transfered
Time frame
3-4 weeks after embryo transfer2
Biochemical pregnancy rate
positive beta-human chorionic gonadotropin (hCG)
Time frame
10 to 12 days after embryo transfer3
Clinical pregnancy rate
A positive heart beat at ultrasound
Time frame
3-4 weeks after embryo transfer4
Miscarriage rate
any spontaneous abortion that occurred after confirmation of clinical pregnancy
Time frame
before completion of 12 weeks of gestationSponsors and contacts
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Source ClinicalTrials.gov