Antagonist/Letrozole in Poor Responders
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Stimulation |
Drug: letrozole Drug: oral contraceptive (Marvelone) Drug: GnRH agonist (buserelin) Drug: recombinant FSH or hMG Drug: ganirelix acetate |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | GnRH Antagonist /Letrozole Versus Microdose GnRH Agonist Flare Protocol in Poor Responders Undergoing in Vitro Fertilization |
- pregnancy rate [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
- stimulation outcomes [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 180 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
A/L: Poor responders who will receive letrozole and GnRH antagonist for ovarian stimulation
|
Drug: letrozole
letrozole 5mg/day from day 3 to day 7 of menstrual cycle
Other Name: letrozole (Femara, Novartis, East Hanover, NJ)
Drug: oral contraceptive (Marvelone)
oral contraceptive, first 21 days
Other Name: Marvelon
Drug: recombinant FSH or hMG
recombinant FSH or hMG 300-450 IU/day
Other Names:
Drug: 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 Name: Antagon
|
|
Active Comparator: 2
MF: In this arm poor responders are treated by microdose GnRH agonist flare protocol
|
Drug: oral contraceptive (Marvelone)
oral contraceptive, first 21 days
Other Name: Marvelon
Drug: GnRH agonist (buserelin)
50 µg SC twice daily
Other Name: suprefact
Drug: recombinant FSH or hMG
recombinant FSH or hMG 300-450 IU/day
Other Names:
|
Detailed 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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- at least one previous failed IVF cycle in which three or fewer follicles with a mean diameter of 16 mm were achieved, and/or
- serum E2 level measured on the day of hCG administration was ≤500 pg/ml
Exclusion Criteria:
- day 3 serum FSH level ≥12 mIU/mL
- there is no age limit
Contacts and Locations| Contact: homa oskouian, M.D. | 9151119557 ext +98 | homaoskouian@gmail.com |
| Contact: robab davar, M.D. | 8247085 ext +98351 | r_davar@yahoo.com |
| Iran, Islamic Republic of | |
| Research and clinical center for infertility | Recruiting |
| Yazd, Iran, Islamic Republic of, 8916877391 | |
| Contact: homa oskouian, MD 9151119557 ext +98 homaoskouian@gmail.com | |
| Contact: robab davar, MD 8247085 ext +98351 r_davar@yahoo.com | |
| Principal Investigator: homa oskouian, MD | |
| Principal Investigator: robab davar, MD | |
| Principal Investigator: | homa oskouian, M.D. | Research and clinical center for infertility |
| Principal Investigator: | robab davar, MD | Research and clinical center for infertility |
More Information
No publications provided
| Responsible Party: | Robab Davar, Yazd research and clinical center for infertility |
| ClinicalTrials.gov Identifier: | NCT00823004 History of Changes |
| Other Study ID Numbers: | 1969yazdRCCI |
| Study First Received: | January 14, 2009 |
| Last Updated: | January 25, 2010 |
| Health Authority: | Iran: Ministry of Health |
Keywords provided by Yazd Research & Clinical Center for Infertility:
|
controlled ovarian hyperstimulation pregnancy rate Poor responders GnRH antagonist |
GnRH agonist letrozole in vitro fertilization controlled ovarian hyperstimulation |
Additional relevant MeSH terms:
|
Buserelin Triptorelin Contraceptive Agents Contraceptives, Oral Ganirelix Deslorelin Letrozole Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Luteolytic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Aromatase Inhibitors |
ClinicalTrials.gov processed this record on October 18, 2012
