NCT06738602

Brief Summary

compare the effectiveness and safety of the progestin primed ovarian stimulation (PPOS) protocol versus the antagonist protocol in hyper-responder patients scheduled for a freeze-all policy

Trial Health

65
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Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Dec 2024

Typical duration for all trials

Status
not yet recruiting

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

Study Progress45%
Dec 2024Dec 2027

First Submitted

Initial submission to the registry

December 10, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

December 30, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

December 10, 2024

Last Update Submit

December 13, 2024

Conditions

Infertility Assisted Reproductive Technology

Keywords

progestin primed ovarian stimulation

Outcome Measures

Primary Outcomes (1)

  • • Clinical pregnancy rate: The presence of a gestational sac with fetal heartbeat on ultrasound at 7 weeks of gestation. • Live birth rate: The delivery of a live-born infant beyond 24 weeks of gestation

    the measure unit is the presence of pulsation in 7-week gestational sac or delivery if fetus beyond 24 weeks as if fetus below 24 w gestation , it's considered abortion

    1 year

Study Arms (2)

Progestin Primed Ovarian Stimulation Protocol group

Antagonist Protocol group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale with primary or secondary infertility
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

* Eligible patients will be identified and recruited from the IVF Unit at Women's Health Hospital. * Informed consent will be obtained from all participants prior to inclusion in the study.

You may qualify if:

  • All hyper responder patients according to Olivera equation for overian response peridiction index

You may not qualify if:

  • All normal and poor responder patients according to Olivera equation for overian response peridiction index.
  • Sever male factor infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Khaled Mostafa Principal Investigator, M.Sc

CONTACT

01004770872khaledmostafa8200893@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Comparison between progestin primed ovarian stimulation protocol and antagonist protocol in hyper-responder patients schaduled for freeze all policy

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 17, 2024

Study Start

December 30, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

December 17, 2024

Record last verified: 2024-12