Infertility, Female Clinical Trial
— POROfficial title:
Repeated Luteal Phase Ovarian Stimulation (Second Step Protocol) in Poor Responder Patients
Reduced ovarian reserve and the consequent poor ovarian response are very recurent in
infertile patients, indeed a percentage of 10%-24% of couples addressed to infertility
program may be classified as Poor Ovarian Responder (POR).
Objective: To evaluate whether the repeated luteal phase stimulation (Second Step) permits a
significantly higher number of oocytes retrieved in POR when compared to conventional
follicular stimulation.
Interventions: The follicular phase stimulation is conduced according to a standardized
Antagonist protocol or Short protocol (with GnRH agonist) using recombinant or urinary
gonadotropins (starting dose 300 or 450 UI) or a long lasting recombinant gonadotropin
(Corifollitropin alfa 150 mcg).
Two - six days after the first oocyte retrieval a second gonadotropin stimulation will be
started with a GnRH antagonist protocol (the stimulation will be started with 250 UI of human
menopausal gonadotropin (hMG) and a GnRH antagonist (GnRH-an) 0,25 mg\die will be
administered when the leading follicle is ≥ 14 mm until hCG (human chorionic gonadotropin)
criteria are met. When at least two follicles had reached 17-18 mm in diameter, ovulation
will be triggered with a single subcutaneous bolus of urinary human chorionic gonadotropin
(10.000 UI ) and oocyte retrieval will be performed after 35 hours.
Two or Three months after the second oocyte retrieval the Embryo transfer (ET) will be
performed after endometrial preparation with Estradiol Valerate and intramuscular
Progesterone.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | September 2019 |
Est. primary completion date | March 30, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Antral Follicular Count =7 follicles - Number of oocyte retrieved with First oocyte retrieval = 2 Exclusion Criteria: - Antral follicular Count < 7 - Anti-Müllerian hormone (AMH) >1.1 ng \mL - Number of oocyte retrieved with First oocyte retrieval > 2 - Absence of antral follicles after First oocyte retrieval |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale G. Bernabeo | Ortona | Chieti |
Lead Sponsor | Collaborator |
---|---|
Università degli Studi 'G. d'Annunzio' Chieti e Pescara |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of oocyte Retrieved | Number of oocyte Retrieved after the first oocyte retrieval vs Number of oocyte Retrieved after the second oocyte retrieval | 15 days after the Second oocyte retrieval | |
Secondary | Number of Embryos Obtained | Number of Embryos Obtained after the Follicular Phase Stimulation and intracytoplasmic sperm injection vs Number of Embryos obtained after Luteal Phase Stimulation and intracytoplasmic sperm injection | 15 days after the Second oocyte retrieval |
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