IVF, Fertility Issues, Infertility
Conditions
Keywords
GnRH Antagonist, Progestin Primed Ovarian Stimulation, Infertility, Ovarian Stimulation
Brief summary
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.
Detailed description
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. Ovarian stimulation will be conducted according to the assigned arm protocol. Both artificially prepared and modified natural cycles will be eligible to be included and the choice will be done according to the doctor's preference and the patient's menstrual cycle regularity. * For artificially prepared transfers, Estradiol Hemihydrate (Estrofem©, 2mg, Novo Nordisk, Malov/Denmark) 3x1 PO will be started on the day 2 of the menstrual cycle. After 12-14 days of usage, in order not to cancel the cycle, endometrial thickness needs measured at least 7mm and serum progesterone level \< 1.5 ng/mL. * For luteal support in addition to Progesterone (Progestan Dex©, 25mg, Kocak Farma İlaç ve Kimya Sanayi A.Ş., Istanbul, Turkiye) 2x1 SC once, with a 12-hour interval at day 14 of the menstrual cycle; Progesterone (Progestan©, 200mg, Kocak Farma İlaç ve Kimya Sanayi A.Ş., Istanbul, Turkiye) 2x1 PV will be started and continued for 5 days. Embryo transfer will be performed at 6th day. Estradiol Hemihydrate will be stopped on week 2 and progesterone support will be continued until the 8th week of gestation.
Interventions
DRUGProgestin
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.
DRUGGnRH antagonist
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.
Sponsors
Nesta Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI \> 18 kg/m2 ve \<35 kg/m2 * Couples that accept being included in the study * Couple accepting thawed embryo transfer
Exclusion criteria
* Known chromosomal abnormality in either member of the couple * Couples with unexplained infertility * BMI \> 30 kg/m2 * Mullerian malformations * Undergoing oocyte cryopreservation for medical reasons (such as malignancies) * Couple insists on fresh embryo transfer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blastulation Rate | Day 5 or 6 after fertilization | number of blastocysts up to day 6 / the number of fertilized 2PN embryos |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PGT Results | 14 days after blastocyte culture sampling | Euploidy and aneuploidy rates |
| Ongoing pregnancy | on gestational week 12 | Fetal heart rate examination via USG |
| Live Birth Rate | 9 months | For pregnancies resulted within the study period, live birth/embryo transfer count |
| Chemical Pregnancy | on day 11 after transfer | Serum ß-hcg level |
Countries
Turkey (Türkiye)
Contacts
Primary ContactZuhal Yucel, B.N.
Outcome results
None listed