Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation

Phase 2

Not yet recruiting

• Conditions: Infertility
• Interventions: Drug: GnRH antagonist; Drug: Progestin primed ovarian stimulation

• Registration Number: NCT06212102
• Lead Sponsor: Bedaya Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-07
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-18
• Last Update Submitted: 2024-01-20
• Last Update Posted: 2024-01-23
• Study Start: 2024-02
• Primary Completion: 2026-03
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Patients belonging to Poseidon group 4

Exclusion Criteria

• PCOS
• Endometriosis
• History of recurrent abortion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRH antagonist group	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. In subsequent cycle, frozen embryo transfer was done
Progestin primed ovarian stimulation group	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. In subsequent cycle, frozen embryo transfer was done

Primary Outcome Measures

Name	Time	Method
Medications costs per retrieved oocyte	Ten to fifteen days after starting ovarian stimulation]	Total cost of medications used in all cycles/number of retrieved oocytes

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	5 weeks after embryo transfer]	Presence of intrauterine gestational sac detected by transvaginal ultrasound
Ongoing Pregnancy Rate	18 weeks after embryo transfer]	Pregnancies continued beyond 20 weeks gestation

Trial Locations

Locations (1)

Bedaya Hospital; 🇪🇬 Giza, Egypt