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

NCT06396390 | Not Yet Recruiting Phase 4

• 1 other identifier: 2024001
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

IVF; Fertility Issues; Infertility

Keywords

GnRH Antagonist; Progestin Primed Ovarian Stimulation; Infertility; Ovarian Stimulation

Outcome Measures

Primary Outcomes (1)

• Blastulation Rate

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

  Day 5 or 6 after fertilization

Secondary Outcomes (4)

• PGT Results

  14 days after blastocyte culture sampling

• Ongoing pregnancy

  on gestational week 12

• Live Birth Rate

  9 months

• Chemical Pregnancy

  on day 11 after transfer

Study Arms (2)

Progestin Primed Ovarian Stimulation (PPOS)

EXPERIMENTAL

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

Drug: Progestin

GnRH Antagonist Stimulation

ACTIVE COMPARATOR

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

Drug: GnRH antagonist

Interventions

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.

Also known as: Progestin Primed Ovarian Stimulation Protocol

Progestin Primed Ovarian Stimulation (PPOS)

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.

Also known as: GnRH Antagonist Ovarian Stimulation Protocol

GnRH Antagonist Stimulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI \> 18 kg/m2 ve \<35 kg/m2
• Couples that accept being included in the study
• Couple accepting thawed embryo transfer

You may not qualify if:

• 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

Sponsors & Collaborators

• Nesta Clinic: lead

Study Sites (1)

Nesta Clinic

Istanbul, Sisli, 34349, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Interventions

Progestins; LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Ercan Bastu, M.D.

  Owner

  STUDY DIRECTOR

Central Study Contacts

Zuhal Yucel, B.N.

CONTACT

+90 542 125 29 99; zuhal.yucel@nestaclinic.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: At least 2 years after publication
• Access Criteria: Upon request

Locations

TU (1)