Clinical Trials Logo

Clinical Trial Summary

Failure to respond to controlled ovarian hyperstimulation (COH) is still a major concern in assisted reproduction and there is no consensus on the ovarian stimulation choice regime for poor responders.

Aim: To evaluate and compare the efficacy of a microdose GnRH agonist flare (MF) and a GnRH antagonist/letrozole (A/L) protocols in poor responders undergoing in vitro fertilization (IVF).

Methods: One hundred eighty poor responder patients will be randomized to an ovarian stimulation protocol with either a MF or a letrozole and high dose FSH/hMG and flexible GnRH antagonist protocol.


Clinical Trial Description

All women receive 21 days of an oral contraceptive. A MF protocol will be used for ovarian stimulation in 90 patients. Three days after the last pill, a GnRH-agonist buserelin (Suprefact, Aventis Pharma, Frankfurt, Germany) 50 µg SC twice daily will be initiated and two days after that, recombinant FSH (Gonal-F, Serono, Aubonne, Switzerland) or hMG (Merional, IBSA, Lugano, Switzerland) 300-450 IU/day will be administered. Ninetyty patients will be assigned to an A/L protocol. After oral contraceptive withdrawal bleeding on day 3 of cycle, recombinant FSH or hMG 300-450 IU/day will be initiated and letrozole (Femara, Novartis, East Hanover, NJ) 5 mg/day will be administered for 5 days. When the dominant follicle reached 14 mm in mean diameter, ganirelix acetate (Antagon, Organon, West Orange, NJ) 0.25 mg SC daily will be started.

Patients weill be monitored by serial vaginal ultrasonography and measurement of serum E2 level. When at least two follicles with a mean diameter of 18 mm will be achieved hCG (Pregnyl, Organon, Oss, the Netherlands) 10000 IU will be administered. Cycle cancellation will be considered when fewer than two follicles with normal growth pattern weill be noted.

Oocyte retrieval will be performed 34-36 hours after hCG administration. Conventional IVF or intracytoplasmic sperm injection (ICSI) will be performed as appropriate. Embryos with 4-6 equally sized blastomers on day 2 with ≤ 20% fragmentation and no multinucleation will be considered top quality embryos. Embryos with 2-6 equally or unequally blastomers with ≤20% fragmentation and no multinucleation will be considered good quality embryos. Embryos will be transferred on day 2 or 3 under ultrasound guidance, with a C.C.D. embryo transfer catheter ( Laboratoire C.C.D., Paris, France). Luteal support with progesterone in oil (Progesterone, Aburaihan Co., Tehran, Iran) 100 mg daily IM will be started on the day of oocyte retrieval.

Serum β-hCG level will be measured 14 days after embryo transfer and a transvaginal ultrasonography will be performed 3 weeks after positive β-hCG for documentation of gestational sac and fetal heart activity. Clinical pregnancy will be considered as the presence of a gestational sac with fetal heart activity. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00823004
Study type Interventional
Source Yazd Research & Clinical Center for Infertility
Contact
Status Completed
Phase Phase 1/Phase 2
Start date June 2008
Completion date October 2009

See also
  Status Clinical Trial Phase
Completed NCT01121991 - A Prospective Study to Evaluate the Addition of Subcutaneous Recombinant Human-Luteinizing Hormone With Recombinant Human-Follicle Stimulating Hormone on Follicular Development in Women Undergoing Ovarian Stimulation for Assisted Reproductive Technologies Phase 3
Not yet recruiting NCT04539067 - Effect of Controlled Ovarian Stimulation in Quality of Oocyte and Embryo Phase 2
Recruiting NCT02715336 - Efficacy and Safety of Medication Used to Stimulate Ovulation Phase 4
Not yet recruiting NCT03298750 - Mechanical Stimulation of the Ovary for Infertility Treatment in Patients With Very Low Ovarian Reserve N/A
Completed NCT03939403 - Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor Phase 4
Recruiting NCT06142708 - The Effect of Dual Trigger (GnRH Agonist + hCG) for Final Maturation in Oocyte Donors With History of a Previous Cycle With Suboptimal Response to GnRH Agonist Only Trigger N/A
Recruiting NCT05166668 - Letrozole /GnRH Antagonist Protocol in Women Over 40 Years Undergoing ICSI Cycle N/A
Completed NCT04549649 - The Effect of Dual Trigger for Final Oocyte Maturation on IVF/ICSI Outcomes in Patients With Suboptimal Ovarian Response N/A
Terminated NCT01816789 - Age Versus Ovarian Reserve Markers Based Therapy in IVF (IVF)/Intracytoplasmic Sperm Injection (ICSI) Cycles Phase 4
Not yet recruiting NCT06175832 - PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study Phase 4
Completed NCT00830492 - Clomiphene Citrate (CC)/Gonadotropin/Gonadotropin Releasing Hormone (GnRH) Antagonist Versus Gonadotropin/GnRH Agonist Phase 4
Completed NCT01145144 - Dehydroepiandrosterone Supplementation for Poor Responder Patients During in Vitro Fertilization Treatment N/A
Completed NCT00829075 - Impact of Three Different Gonadotrophin Regimes on Egg Donation Program Phase 4
Completed NCT01037699 - Luteinizing Hormone (LH) Supplementation in Gonadotropin-releasing Hormone (GnRH) Antagonist Cycles Phase 3
Completed NCT01112358 - Lutropin Alfa in Women at Risk of Poor Response Phase 2
Recruiting NCT03400722 - Double Ovarian Stimulation as Accumulation Strategy for Older Infertile Patients With Suboptimal Ovarian Response Phase 4
Completed NCT00669786 - Human Menopausal Gonadotropin (HMG) vs Recombinant Follicle Stimulating Hormone (rFSH) in Gonadotropin Releasing Hormone (GnRH) Antagonist Cycles Phase 3