NCT05951400

Brief Summary

To compare the effectiveness and safety of Progesterone Primed Ovarian Stimulation protocol (PPOS) using Dydrogestrone vs GnRH Antagonist Protocol in patients with expected high ovarian response undergoing ICSI cycle

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

June 4, 2023

Last Update Submit

April 11, 2026

Conditions

IVFPCO

Keywords

CetrorelixDydrogesteroneGnRh antagonist

Outcome Measures

Primary Outcomes (1)

  • oocytes retrieved

    Number of oocytes retrieved classified

    1 month of induction for ICSI trial

Secondary Outcomes (2)

  • Duration of stimulation days.

    1 month

  • chemical pregnancy rate

    1 month

Study Arms (2)

Dydrogestrone

EXPERIMENTAL

For pituitary suppression, the patients will receive either Dydrogestrone (Duphaston30 mg/d; Abbott Healthcare, USA) orally starting at day 2-3

Drug: Dydrogesterone Tablets

GnRH antagonist

ACTIVE COMPARATOR

For pituitary suppression, the patients will receive GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day.

Drug: Cetrorelix

Interventions

Dydrogesterone TabletsDRUG

used for pituitary suppression in ICSI cycle

Also known as: Duphaston
Dydrogestrone
CetrorelixDRUG

GnRH antagonist for pituitary suppression

Also known as: cetrotide
GnRH antagonist

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • undergoing trial of ICSI.
  • BMI ≤ 30
  • AMH ≥3.5
  • AFC ≥ 20

You may not qualify if:

  • Any known contraindications to the approved fertility drugs.
  • Severe endometriosis.
  • Uterine malformations or abnormal uterine cavity.
  • Uncontrolled endocrinopathies:DM,hyperthyroidism, hypothyroidism
  • Severe male factor
  • History of recurrent ICSI failure or recurrent miscarriage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

MeSH Terms

Interventions

Dydrogesteronecetrorelix

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Beni-Suef University

    Faculty of Medicine Beni-Suef University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

First Submitted

June 4, 2023

First Posted

July 19, 2023

Study Start

January 1, 2024

Primary Completion

March 30, 2026

Study Completion

April 5, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

EG(1)