Health TrialsbyHealthPanel

INtensity of OVarian Stimualtion and Euploid Embryos

ConditionFertility
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age38-42
SponsorFundación Santiago Dexeus Font

About this trial

This randomized trial was designed as a no-inferiority trial aiming to evaluate if the intensity of stimulation (a milder vs a more intense approach) may have an impact on the number of euploid embryos and the morpho kinetic parameters in advanced age women undergoing PGT-A with a PPOS protocol.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Infertile patients with indication for IVF

Undergoing preimplantation genetic screening cycles

AMH >= 1.5 ng/ml and < 3.5 ng/ml (AMH result of up to one year will be valid)

BMI 18.5 - 30 Kg/m2

Disqualifiers

Severe male factor requiring TESE (testicular sperm extraction)

AMH < 1.5 ng/ml or >= 3.5 ng/ml

Administration of any other drug potentially interfering with the treatment

Contraindication for hormonal treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Follitropin-delta (Rekovelle) 20 mcg/day from D1

    Drug

    On day 2 or 3 of the menstrual cycle, daily injections of 20 mcg of Rekovelle (Stimulation Day 1) will be administered. Scan controls blood exams are performed on stimulation days 6, 8, 10 and, according to clinical needs, until trigger day. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.

  • Follitropin-delta (Rekovelle) 15 mcg/day from D1

    Drug

    On day 2 or 3 of the menstrual cycle, daily injections of 15 mcg of Rekovelle (Stimulation Day 1) will be administered. Scan controls and blood exams are performed on stimulation days 6, 8, 10 and, according to clinical needs, until trigger day. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Follitropin-delta 20 mcg/day from D1Experimental treatment 1 intervention
Group B: Follitropin-delta 15 mcg/day from D1Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of euploid embryos

Number of euploid embryos

Time frame
Trough study completion, an average of 20-30 days.

Secondary outcomes

1

Gonadotropin dose

Total gonadotropin dose used

Time frame
Up to oocyte pickup, an average of 10-20 days
2

Length of stimulation

Days of stimulation

Time frame
Up to oocyte pickup, an average of 10-20 days
3

Estradiol

Estradiol level

Time frame
Up to oocyte pickup, an average of 10-20 days
4

Progesterone

Progesterone level

Time frame
Up to oocyte pickup, an average of 10-20 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación Santiago Dexeus Font

Lead sponsor

Source ClinicalTrials.gov
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