Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06212102
• Other study ID #: Double stimulation
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 2024
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Bedaya Hospital
• Contact: Usama M Fouda, Prof.
• Phone: +201095401375
• Email: umfrfouda[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this randomized controlled trial was 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 44 Years

Eligibility

Inclusion Criteria:

Patients belonging to Poseidon group 4

Exclusion Criteria:

• PCOS

• Endometriosis

• History of recurrent abortion

Related Conditions & MeSH terms

• Infertility

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Bedaya Hospital	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Bedaya Hospital

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical pregnancy rate	Presence of intrauterine gestational sac detected by transvaginal ultrasound	5 weeks after embryo transfer]
Secondary	Ongoing Pregnancy Rate	Pregnancies continued beyond 20 weeks gestation	18 weeks after embryo transfer]