Health TrialsbyHealthPanel

Comparison of Progestin Primed Ovarian Stimulation (PPOS) vs.GnRH Antagonist Methods on IVF Outcomes

ConditionsIVFFertility IssuesInfertility
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorNesta Clinic

About this trial

The goal of this randomized clinical trial is to compare the effects of two different ovarian stimulation methods: Progestin Primed Ovarian Stimulation (PPOS) vs. GnRH Antagonist in embryologic outcomes of IVF Patients.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

BMI > 18 kg/m2 ve <35 kg/m2

Couples that accept being included in the study

Couple accepting thawed embryo transfer

Disqualifiers

Known chromosomal abnormality in either member of the couple

Couples with unexplained infertility

BMI > 30 kg/m2

Mullerian malformations

Trial design

Design model

Parallel

Treatments tested in this trial

  • Progestin

    Drug

    In this regimen, Dydrogesterone (Duphaston©; 10mg; Deva Holding, Tekirdag/Turkiye) 3x1 PO will be started on day 2 of menstrual cycle and will be continued until the trigger day. The patient's dosage will be tailored based on their BMI, AMH value, and the number of follicles observed during the ultrasound examination on the 2nd day of the menstrual cycle. For triggering, Choriogonadotropin-α (Ovitrelle©, 250 mcg/0.5 mL, Merck Serono S.p.A., Bari/Italy) 1 amp SC + Triptorelin Acetate (Gonapeptyl©, 0.1mg/mL, Ferring GmbH, Kiel/Germany) 2 amp SC will be used. All oocytes picked-up will be frozen.

  • GnRH antagonist

    Drug

    In this regimen, Cetrorelix (Cetrotide©, 250 mcg/mL, Pierre Fabre Medicament Production, Idron, France) 1x1 SC will be started on day 7 of menstrual cycle and will be continued until the trigger day. For triggering, Choriogonadotropin-α (Ovitrelle©, 250 mcg/0.5 mL, Merck Serono S.p.A., Bari/Italy) 1 amp SC + Triptorelin Acetate (Gonapeptyl©, 0.1mg/mL, Ferring GmbH, Kiel/Germany) 2 amp SC will be used. All oocytes picked-up will be frozen.

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: Progestin Primed Ovarian Stimulation (PPOS)Experimental treatment 1 intervention
Group B: GnRH Antagonist StimulationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Blastulation Rate

number of blastocysts up to day 6 / the number of fertilized 2PN embryos

Time frame
Day 5 or 6 after fertilization

Secondary outcomes

1

PGT Results

Euploidy and aneuploidy rates

Time frame
14 days after blastocyte culture sampling
2

Ongoing pregnancy

Fetal heart rate examination via USG

Time frame
on gestational week 12
3

Live Birth Rate

For pregnancies resulted within the study period, live birth/embryo transfer count

Time frame
9 months
4

Chemical Pregnancy

Serum ß-hcg level

Time frame
on day 11 after transfer

Other outcomes

Sponsors and contacts

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

Nesta Clinic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: