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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progestin Primed Ovarian Stimulation (PPOS) | Experimental | In this patient group, progestin based protocol is going to be the main course of treatment. |
|
| GnRH Antagonist Stimulation | Active Comparator | In this patient group, GnRH Antagonist treatment protocol is going to be the main course of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blastulation Rate | number of blastocysts up to day 6 / the number of fertilized 2PN embryos | Day 5 or 6 after fertilization |
| Measure | Description | Time Frame |
|---|---|---|
| PGT Results | Euploidy and aneuploidy rates | 14 days after blastocyte culture sampling |
| Ongoing pregnancy | Fetal heart rate examination via USG |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zuhal Yucel, B.N. | Contact | +90 542 125 29 99 | zuhal.yucel@nestaclinic.com |
| Name | Affiliation | Role |
|---|---|---|
| Ercan Bastu, M.D. | Owner | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nesta Clinic | Istanbul | Sisli | 34349 | Turkey (Türkiye) |
IPD will be available upon request for at least 2 years after publication.
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At least 2 years after publication
Upon request
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D011372 | Progestins |
| C092464 | LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)- |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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|
| 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. |
|
|
| on gestational week 12 |
| Live Birth Rate | For pregnancies resulted within the study period, live birth/embryo transfer count | 9 months |
| Chemical Pregnancy | Serum ß-hcg level | on day 11 after transfer |
| D020164 | Chemical Actions and Uses |