Clinical trial NCT06396390: Comparison of Progestin Primed Ovarian Stimulation (PPOS) vs.GnRH Antagonist Methods on IVF Outcomes
Official title: The Comparative Results of Progestin Primed Ovarian Stimulation (PPOS) and GnRH Antagonist Ovarian Stimulation Methods on IVF Outcomes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: IVF
Fertility Issues
Infertility
Keywords: GnRH Antagonist
Progestin Primed Ovarian Stimulation
Infertility
Ovarian Stimulation
Lead sponsor: Nesta Clinic
Sponsor class: NETWORK
First posted: 2024-05-02
Enrollment: 152
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blastulation Rate
timeFrame: Day 5 or 6 after fertilization
Secondary outcomes:
measure: PGT Results
timeFrame: 14 days after blastocyte culture sampling
measure: Ongoing pregnancy
timeFrame: on gestational week 12
measure: Live Birth Rate
timeFrame: 9 months
measure: Chemical Pregnancy
timeFrame: on day 11 after transfer
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Nesta Clinic
state: Sisli
Study officials:
affiliation: Owner
name: Ercan Bastu, M.D.
role: STUDY_DIRECTOR
References: