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

Nesta Clinic

Status and phase: Not yet enrolling; Phase 4

Conditions: Infertility; IVF; Fertility Issues

Treatments: Drug: Progestin; Drug: GnRH antagonist

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06396390

2024001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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152 participants in 2 patient groups

Progestin Primed Ovarian Stimulation (PPOS)

Experimental group

Description:

In this patient group, progestin based protocol is going to be the main course of treatment.

Treatment:

Drug: Progestin

GnRH Antagonist Stimulation

Active Comparator group

Description:

In this patient group, GnRH Antagonist treatment protocol is going to be the main course of treatment.

Treatment:

Drug: GnRH antagonist