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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Ahmed S Saad, phD
- Telefoonnummer: 020 +201221709989
- E-mail: drahmedsaad@live.com
Studie Contact Back-up
- Naam: Walid A Abdel Halim, phD
- Telefoonnummer: 020 0201228343376
- E-mail: waleedabdellateef@gmail.com
Studie Locaties
-
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Qalyubia Governorate
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Banhā, Qalyubia Governorate, Egypte, 13512
- Hawaa Fertility Center
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Contact:
- Ahmed s saad, phD
- Telefoonnummer: 020 01221709989
- E-mail: drahmedsaad@live.com
-
Contact:
- walid a abdelateef, phD
- Telefoonnummer: 020 0201100434632
- E-mail: waleedabdelateef@gmail.com
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
|
|
Actieve vergelijker: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Metaphase II (Mii) oocytes
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of oocytes retrieved
Tijdsspanne: Day 0
|
Total numbers
|
Day 0
|
|
Fertilization rate 2 pronuclei (2PN)
Tijdsspanne: on day 1
|
Fertilization rate (2PN) check
|
on day 1
|
|
Quality of day-3 embryos
Tijdsspanne: on day 3
|
Quality of day-3 embryos (gradeing)
|
on day 3
|
|
LH measure
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: At 6 wks of pregnancy
|
Clinical pregnancy rate per embryo transfer
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At 6 wks of pregnancy
|
|
Cost per cycle
Tijdsspanne: at day 0
|
Cost per stimulation cycle (drug cost only) in EGP
|
at day 0
|
|
Number of Day 3 embryos
Tijdsspanne: Day 3
|
Measure the numbers of day 3 embryos
|
Day 3
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Ahmed s Saad, phD, Professor of OB & GYN
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Hawaa-11
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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