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NCT Number: NCT06396390

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Progestin Primed Ovarian Stimulation Protocol

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.

Other names: GnRH Antagonist Ovarian Stimulation Protocol

Primary outcomes

  1. Blastulation Rate

    Time frame: Day 5 or 6 after fertilization

    number of blastocysts up to day 6 / the number of fertilized 2PN embryos

Secondary outcomes

  1. PGT Results

    Time frame: 14 days after blastocyte culture sampling

    Euploidy and aneuploidy rates

  2. Ongoing pregnancy

    Time frame: on gestational week 12

    Fetal heart rate examination via USG

  3. Live Birth Rate

    Time frame: 9 months

    For pregnancies resulted within the study period, live birth/embryo transfer count

  4. Chemical Pregnancy

    Time frame: on day 11 after transfer

    Serum ß-hcg level

Study contacts

Contact information is provided by the study sponsor or research team.

Zuhal Yucel, B.N.

CONTACT

[email protected]

+90 542 125 29 99

Sponsors and collaborators

Lead sponsor

Nesta Clinic

Network

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 2, 2024
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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