Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation

ConditionInfertility
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age35-44
SponsorBedaya Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

PCOS

Endometriosis

History of recurrent abortion

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Progestin primed ovarian stimulation groupExperimental treatment 1 intervention
Group B: GnRH antagonist groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Medications costs per retrieved oocyte

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

Time frame
Ten to fifteen days after starting ovarian stimulation]

Secondary outcomes

1

Clinical pregnancy rate

Presence of intrauterine gestational sac detected by transvaginal ultrasound

Time frame
5 weeks after embryo transfer]
2

Ongoing Pregnancy Rate

Pregnancies continued beyond 20 weeks gestation

Time frame
18 weeks after embryo transfer]

Other outcomes

Sponsors and contacts

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Bedaya Hospital

Lead sponsor

Cairo University

Collaborator