Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSI (PPOS)
Drospirenone-Primed Ovarian Stimulation (PPOS) Versus Flexible GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing a Freeze-All Strategy: A Pilot Randomized Controlled Trial
Participants will:
- Take either drospirenone (a daily pill) or the standard daily injection during their ovarian stimulation cycle, alongside their regular fertility hormone injections
- Undergo egg retrieval, with all resulting embryos frozen (no fresh embryo transfer in this study)
- Have a frozen embryo transferred in a later cycle
- Complete two short questionnaires about their treatment experience - once before starting the injections/pills, and once after the stimulation phase ends
- Be followed to determine if the embryo transfer results in a pregnancy
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Single-center, open-label, 1:1 parallel-group pilot RCT, stratified by POSEIDON group. Superiority framing is not used - this pilot is not powered for hypothesis testing on efficacy outcomes; those are reported descriptively with 95% confidence intervals.
Freeze-all is mandated in both arms by protocol (not patient choice). No patient is offered fresh transfer in either arm, so no patient is excluded for requesting one; this is stated explicitly in the consent process so expectations are set at enrollment.
Both arms use a unified flexible start, triggered by leading follicle diameter reaching 14mm - not a fixed calendar day. Rather than fixing both arms to the same stimulation day (which would not account for individual variability in follicular growth rate, a particular concern in POR), both the antagonist and the drospirenone are initiated on the same physiological trigger: once the leading follicle reaches 14mm, whichever arm the patient is randomized to. This achieves genuine unification across arms (identical starting criterion, applied identically) while remaining individualized to each patient's own stimulation pace. This design has direct precedent, as described in Section 2, and retrospective evidence in POR specifically favors flexible-start over fixed-day dosing on oocyte and fertilization outcomes without increased LH-surge risk.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Ahmed S Saad, phD
- Telefonnummer: 020 +201221709989
- E-post: drahmedsaad@live.com
Studera Kontakt Backup
- Namn: Walid A Abdel Halim, phD
- Telefonnummer: 020 0201228343376
- E-post: waleedabdellateef@gmail.com
Studieorter
-
-
Qalyubia Governorate
-
Banhā, Qalyubia Governorate, Egypten, 13512
- Hawaa Fertility Center
-
Kontakt:
- Ahmed s saad, phD
- Telefonnummer: 020 01221709989
- E-post: drahmedsaad@live.com
-
Kontakt:
- walid a abdelateef, phD
- Telefonnummer: 020 0201100434632
- E-post: waleedabdelateef@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Spontaneous menstrual cycles (21-35 days)
- Poor ovarian response per Bologna criteria (≥2 of 3): advanced age ≥40 or risk factor for POR; previous poor response (≤3 oocytes with conventional stimulation); abnormal ovarian reserve (AFC <7 or AMH <1.1 ng/mL)
- POSEIDON group recorded at enrollment (1-4) for stratified randomization and pre-specified subgroup description - corrects a known limitation of Bologna-only classification, which pools biologically distinct POR phenotypes
- Indication for IVF/ICSI
- Willing and able to undergo mandatory freeze-all/FET protocol
- Signed informed consent, including explicit acknowledgment that fresh transfer is not offered in either study arm
Exclusion Criteria:
- Contraindication to ovarian stimulation
- Known müllerian anomaly
- Uncontrolled systemic disease
- 5 prior failed IVF attempts
- Known contraindication to drospirenone (per product labeling, e.g., renal impairment, adrenal insufficiency, conditions predisposing to hyperkalemia)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Drospirenone
50 cases will receive drospirenone in the form of 1 tablet / d when the leading follicle reaches 14 mm till hCG trigger day
|
A drug drospirenone in the form of 1 tablet / d from 14 mm follicle till hCG trigger day
|
|
Aktiv komparator: cetrorelix
50 cases will receive cetrorelix when the leading follicle reaches 14 mm till hCG trigger day
|
Cetrorelix a drug injection daily sc.
from 14 mm follicle till hCG trigger day
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Metaphase II (Mii) oocytes
Tidsram: Day 0
|
Number of mature (MII) oocytes retrieved between drospirenone-PPOS and GnRH antagonist protocols, both using a unified flexible start (leading follicle 14mm), in POR patients undergoing a mandatory freeze-all strategy,
|
Day 0
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of oocytes retrieved
Tidsram: Day 0
|
Total numbers
|
Day 0
|
|
Fertilization rate 2 pronuclei (2PN)
Tidsram: on day 1
|
Fertilization rate (2PN) check
|
on day 1
|
|
Quality of day-3 embryos
Tidsram: on day 3
|
Quality of day-3 embryos (gradeing)
|
on day 3
|
|
LH measure
Tidsram: on trigger day ( 2 days before day 0)
|
LH measure to follow premature LH surge (LH >15 mIU/mL on trigger day) and premature LH rise (LH >10 mIU/mL)
|
on trigger day ( 2 days before day 0)
|
|
Patient burden score
Tidsram: Day 0
|
Patient-reported treatment burden and satisfaction, measured using the validated Controlled Ovarian Stimulation Impact Measure (COSI; four domains - Interference in Daily Life, Injection Burden, Psychological Health, Compliance Worry), administered at day 0. each patient will give a score from 0-4
|
Day 0
|
|
CPR ( clinical pregnancy rate)
Tidsram: At 6 wks of pregnancy
|
Clinical pregnancy rate per embryo transfer
|
At 6 wks of pregnancy
|
|
Cost per cycle
Tidsram: at day 0
|
Cost per stimulation cycle (drug cost only) in EGP
|
at day 0
|
|
Number of Day 3 embryos
Tidsram: Day 3
|
Measure the numbers of day 3 embryos
|
Day 3
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Ahmed s Saad, phD, Professor of OB & GYN
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Hawaa-11
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
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