NCT07736261

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
15mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

July 22, 2026

Last Update Submit

July 29, 2026

Conditions

Poor Ovarian ReserveInfertility (IVF Patients)

Keywords

poor ovarian responsediminished ovarian reserveDrospirenoneprogestin primed ovarian stimulationGnRH antagonistFreeze all

Outcome Measures

Primary Outcomes (1)

  • Metaphase II (Mii) oocytes

    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

Secondary Outcomes (8)

  • Number of oocytes retrieved

    Day 0

  • Fertilization rate 2 pronuclei (2PN)

    on day 1

  • Quality of day-3 embryos

    on day 3

  • LH measure

    on trigger day ( 2 days before day 0)

  • Patient burden score

    Day 0

  • +3 more secondary outcomes

Study Arms (2)

Drospirenone

EXPERIMENTAL

50 cases will receive drospirenone in the form of 1 tablet / d when the leading follicle reaches 14 mm till hCG trigger day

Drug: Drospirenone drug

cetrorelix

ACTIVE COMPARATOR

50 cases will receive cetrorelix when the leading follicle reaches 14 mm till hCG trigger day

Drug: Cetrorelix 0.25 mg

Interventions

Drospirenone drugDRUG

A drug drospirenone in the form of 1 tablet / d from 14 mm follicle till hCG trigger day

Drospirenone
Cetrorelix 0.25 mgDRUG

Cetrorelix a drug injection daily sc. from 14 mm follicle till hCG trigger day

cetrorelix

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale gender phenotypically and genetically
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindication to ovarian stimulation
  • Known müllerian anomaly
  • Uncontrolled systemic disease
  • prior failed IVF attempts
  • Known contraindication to drospirenone (per product labeling, e.g., renal impairment, adrenal insufficiency, conditions predisposing to hyperkalemia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hawaa Fertility Center

Banhā, Qalyubia Governorate, 13512, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

drospirenone and ethinyl estradiol combinationcetrorelix

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ahmed s Saad, phD

    Professor of OB & GYN

    STUDY DIRECTOR

Central Study Contacts

Ahmed S Saad, phD

CONTACT

+201221709989drahmedsaad@live.com

Walid A Abdel Halim, phD

CONTACT

0201228343376waleedabdellateef@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
stastician
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 100 cases in this novel trial. 50 in each group will be randomized after taking 5 days of ovarian stimulation to either drospirenone tablet/d or cetrorelix injection/d till the day of hCG.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of OB & GYN

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 30, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

the protocol excel sheet

Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations

EG(1)