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

Infertility Clinical Trial

Official title:

The Comparative Results of Progestin Primed Ovarian Stimulation (PPOS) and GnRH Antagonist Ovarian Stimulation Methods on IVF Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06396390
• Other study ID #: 2024001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2024
• Est. completion date: August 1, 2026

Study information

• Verified date: April 2024
• Source: Nesta Clinic
• Contact: Zuhal Yucel, B.N.
• Phone: +90 542 125 29 99
• Email: zuhal.yucel[@]nestaclinic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 152
• Est. completion date: August 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Issues
• Infertility
• IVF

Intervention

Drug:
• Progestin
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-a (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
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-a (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.

Locations

Country	Name	City	State
Turkey	Nesta Clinic	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Nesta Clinic

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blastulation Rate	number of blastocysts up to day 6 / the number of fertilized 2PN embryos	Day 5 or 6 after fertilization
Secondary	PGT Results	Euploidy and aneuploidy rates	14 days after blastocyte culture sampling
Secondary	Ongoing pregnancy	Fetal heart rate examination via USG	on gestational week 12
Secondary	Live Birth Rate	For pregnancies resulted within the study period, live birth/embryo transfer count	9 months
Secondary	Chemical Pregnancy	Serum ß-hcg level	on day 11 after transfer