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Recruiting NCT06212102

Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation

Phase II Interventional Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Progestin primed ovarian stimulation, GnRH antagonist.
Who it may be relevant to
Registry conditions: Infertility. Basic parameters: 35 years — 44 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation: A Randomized Controlled Non-inferiority Trial

Overview

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.

Interventions

  • Drug Progestin primed ovarian stimulation
    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.
  • Drug GnRH antagonist
    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.

Primary outcome measures

  • Medications costs per retrieved oocyte [Time frame: Ten to fifteen days after starting ovarian stimulation]]
Secondary outcome measures (2)
  • Clinical pregnancy rate [Time frame: 5 weeks after embryo transfer]]
  • Ongoing Pregnancy Rate [Time frame: 18 weeks after embryo transfer]]

Eligibility criteria

Inclusion criteria

Patients belonging to Poseidon group 4

Exclusion criteria

  • PCOS
  • Endometriosis
  • History of recurrent abortion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 2 centers
  • Cairo University — Cairo
  • Bedaya Hospital — Giza

Publications

  • 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: PMID 27020168

Identifiers

NCT: NCT06212102 · Double stimulation

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗