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

Phase 4

Not yet recruiting

• Conditions: IVF; Fertility Issues; Infertility
• Interventions: Drug: GnRH antagonist; Drug: Progestin

• Registration Number: NCT06396390
• Lead Sponsor: Nesta Clinic

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.

Study Timeline

• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Study Start: 2024-08-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRH Antagonist Stimulation	GnRH antagonist	In this patient group, GnRH Antagonist treatment protocol is going to be the main course of treatment.
Progestin Primed Ovarian Stimulation (PPOS)	Progestin	In this patient group, progestin based protocol is going to be the main course of treatment.

Primary Outcome Measures

Name	Time	Method
Blastulation Rate	Day 5 or 6 after fertilization	number of blastocysts up to day 6 / the number of fertilized 2PN embryos

Secondary Outcome Measures

Name	Time	Method
Live Birth Rate	9 months	For pregnancies resulted within the study period, live birth/embryo transfer count
PGT Results	14 days after blastocyte culture sampling	Euploidy and aneuploidy rates
Chemical Pregnancy	on day 11 after transfer	Serum ß-hcg level
Ongoing pregnancy	on gestational week 12	Fetal heart rate examination via USG

Trial Locations

Locations (1)

Nesta Clinic; 🇹🇷 Istanbul, Sisli, Turkey