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NCT Number: NCT06212102

Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation

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.

Recruiting

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

35 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Cairo University, Cairo, Cairo Governorate, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients belonging to Poseidon group 4

Exclusion criteria

  • PCOS
  • Endometriosis
  • History of recurrent abortion

Treatment and study plan

Progestin primed ovarian stimulation

Drug

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.

GnRh antagonist

Drug

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 outcomes

  1. Medications costs per retrieved oocyte

    Time frame: Ten to fifteen days after starting ovarian stimulation]

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

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: 5 weeks after embryo transfer]

    Presence of intrauterine gestational sac detected by transvaginal ultrasound

  2. Ongoing Pregnancy Rate

    Time frame: 18 weeks after embryo transfer]

    Pregnancies continued beyond 20 weeks gestation

Study contacts

Contact information is provided by the study sponsor or research team.

Usama M Fouda, Prof.

CONTACT

[email protected]

+201095401375

Sponsors and collaborators

Lead sponsor

Bedaya Hospital

Other

Collaborators

  • Cairo University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 18, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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