Current partner codePEPTIDESDE
NCT06396390·Phase 4·INTERVENTIONAL

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

Status

Not yet recruiting

Phase

Phase 4

Enrollment

152

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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 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.

Interventions

Treatment arms and agents.

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-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.

DRUG

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-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.

Timeline

From registration to results.

  1. First posted

    May 2, 2024

  2. Study start

    Aug 1, 2024

  3. Primary completion

    Jun 1, 2026

  4. Study completion

    Aug 1, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 17, 2024

Outcomes

What the study measures.

Primary outcomes

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

PGT Results

Time frame · 14 days after blastocyte culture sampling

Euploidy and aneuploidy rates

Ongoing pregnancy

Time frame · on gestational week 12

Fetal heart rate examination via USG

Live Birth Rate

Time frame · 9 months

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

Chemical Pregnancy

Time frame · on day 11 after transfer

Serum ß-hcg level

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
45 Years
Sex
FEMALE
Healthy volunteers
Yes

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 locations

1 registered sites.

Turkey (Türkiye). Showing up to 24 locations stored in the fast local snapshot.

Nesta Clinic

Istanbul, Sisli, Turkey (Türkiye)

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Cetrorelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.