NCT06212102

Brief Summary

The aim of this randomized controlled trial is to compare the efficacy and cost-effectiveness of using progestin with GnRH antagonist to prevent premature LH surge in poor responders undergoing double stimulation protocol.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
15mo left

Started May 2024

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
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

Study Progress62%
May 2024Aug 2027

First Submitted

Initial submission to the registry

January 7, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

May 8, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

January 7, 2024

Last Update Submit

April 28, 2026

Conditions

Infertility

Keywords

InfertilityIVF-ETPoor ovarian respondersDouble stimulation

Outcome Measures

Primary Outcomes (1)

  • Medications costs per retrieved oocyte

    Total cost of medications used in all cycles/number of retrieved oocytes

    Ten to fifteen days after starting ovarian stimulation]

Secondary Outcomes (2)

  • Clinical pregnancy rate

    5 weeks after embryo transfer]

  • Ongoing Pregnancy Rate

    18 weeks after embryo transfer]

Study Arms (2)

Progestin primed ovarian stimulation group

EXPERIMENTAL

HMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Progestin (dydrogesterone) 30 mg/day was used to prevent premature LH surge during the FPS and LPS. In subsequent cycle, frozen embryo transfer was done

Drug: Progestin primed ovarian stimulation

GnRH antagonist group

ACTIVE COMPARATOR

HMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Flexible GnRH antagonist protocol (Cetrorelix acetate) (0.2 mg) was used to prevent premature LH surge during the FPS and LPS. In subsequent cycle, frozen embryo transfer was done

Drug: GnRH antagonist

Interventions

Progestin primed ovarian stimulationDRUG

HMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Progestin (dydrogesterone) 30 mg/day was used to prevent premature LH surge during the FPS and LPS.

Progestin primed ovarian stimulation group
GnRH antagonistDRUG

HMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Flexible GnRH antagonist protocol (Cetrorelix acetate) (0.2 mg) was used to prevent premature LH surge during the FPS and LPS.

GnRH antagonist group

Eligibility Criteria

Age35 Years - 44 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients belonging to Poseidon group 4

You may not qualify if:

  • PCOS
  • Endometriosis
  • History of recurrent abortion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo University

Cairo, Cairo Governorate, Egypt

RECRUITING

Bedaya Hospital

Giza, Egypt

NOT YET RECRUITING

Related Publications (1)

  • Ubaldi FM, Capalbo A, Vaiarelli A, Cimadomo D, Colamaria S, Alviggi C, Trabucco E, Venturella R, Vajta G, Rienzi L. Follicular versus luteal phase ovarian stimulation during the same menstrual cycle (DuoStim) in a reduced ovarian reserve population results in a similar euploid blastocyst formation rate: new insight in ovarian reserve exploitation. Fertil Steril. 2016 Jun;105(6):1488-1495.e1. doi: 10.1016/j.fertnstert.2016.03.002. Epub 2016 Mar 25.

    PMID: 27020168BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Samar A Alhofy, M.D, Msc

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Usama M Fouda, Prof.

CONTACT

+201095401375umfrfouda@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2024

First Posted

January 18, 2024

Study Start

May 8, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)