Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2008-06-30
2009-10-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
A/L: Poor responders who will receive letrozole and GnRH antagonist for ovarian stimulation
letrozole
letrozole 5mg/day from day 3 to day 7 of menstrual cycle
oral contraceptive (Marvelone)
oral contraceptive, first 21 days
recombinant FSH or hMG
recombinant FSH or hMG 300-450 IU/day
ganirelix acetate
GnRH antagonist (ganirelix acetate) when a leading follicle reaches a mean diameter of 14 mm, 0.25 mg per day (Antagon, Organon, West Orange, NJ)
2
MF: In this arm poor responders are treated by microdose GnRH agonist flare protocol
oral contraceptive (Marvelone)
oral contraceptive, first 21 days
GnRH agonist (buserelin)
50 µg SC twice daily
recombinant FSH or hMG
recombinant FSH or hMG 300-450 IU/day
Interventions
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letrozole
letrozole 5mg/day from day 3 to day 7 of menstrual cycle
oral contraceptive (Marvelone)
oral contraceptive, first 21 days
GnRH agonist (buserelin)
50 µg SC twice daily
recombinant FSH or hMG
recombinant FSH or hMG 300-450 IU/day
ganirelix acetate
GnRH antagonist (ganirelix acetate) when a leading follicle reaches a mean diameter of 14 mm, 0.25 mg per day (Antagon, Organon, West Orange, NJ)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* serum E2 level measured on the day of hCG administration was ≤500 pg/ml
Exclusion Criteria
* there is no age limit
FEMALE
Yes
Sponsors
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Yazd Research & Clinical Center for Infertility
OTHER
Responsible Party
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homa oskouian
fellowship
Principal Investigators
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homa oskouian, M.D.
Role: PRINCIPAL_INVESTIGATOR
Research and clinical center for infertility
robab davar, MD
Role: PRINCIPAL_INVESTIGATOR
Research and clinical center for infertility
Locations
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Research and clinical center for infertility
Yazd, Yazd Province, Iran
Countries
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Other Identifiers
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1969yazdRCCI
Identifier Type: -
Identifier Source: org_study_id