Clinical trial NCT02070198: Long Acting FSH Plus Antagonist Versus Daily FSH Plus Antagonist Versus Short Agonist Protocol in Poor Responders Undergoing IVF
Official title: Long Acting FSH Plus GnRH Antagonist Versus Daily FSH Plus GnRH Antagonist Versus Short Agonist Regimens in Poor Responder Patients Undergoing IVF: a Randomized Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Female Infertility
Poor Responder
Keywords: Poor responders, IVF, GnRH agonist, GnRH antagonist, recombinant FSH
Lead sponsor: Bioroma
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite the progression in assisted reproductive technology (ART), poor ovarian response to controlled ovarian stimulation remains a challenge for clinicians and a source of distress for patients. Multiple strategies have been tried to overcome these obstacles. The increase of the gonadotropin administration have been associated with a very low pregnancy rate. The introduction of GnRH agonist protocol, which takes advantage of the initial rise in endogenous gonadotropins that follows the agonist administration in the early follicular phase and subsequently prevents a premature LH surge, with fewer cycle cancellations, have improved cycle parameters and increased pregnancy rate. Recently, GnRH antagonists were introduced in ART treatment. They are effective in preventing a premature LH surge and allow for a more natural recruitment of follicles in the follicular phase in a non suppressed ovary. However, the randomized studies comparing the efficacy of these two regimens reported conflicting and nonsignificant results. Moreover, more recently adjuvant therapies for COH such as growth hormone therapy or pyridostigmine, oral L-arginine, and transdermal testosterone failed to improve IVF outcomes. Recently, the new treatment option with corifollitropin alfa, able to keep the circulating FSH level above the threshold necessary to support multi-follicular growth for an entire week, in a GnRH antagonist protocol seems to have a potential beneficial effect in poor responders.

The aim of this study is to compare long-acting FSH/GnRH antagonist with daily FSH/GnRH antagonist with short GnRH agonist protocol on IVF outcome in poor responder patients .


Eligibility criteria: Inclusion Criteria:

* women with at least two of the following criteria: I) age \> 40 years old; II) basal follicular stimulation hormone (FSH) \> 12 mIU/ml; III) three or fewer oocytes retrieved in the previous IVF cycle; IV) low estradiol levels on the day of human chorionic gonadotropin (hCG) administration (\< 1500 pmol/ml).

Exclusion Criteria:

* body mass index \> 30
* biochemical and ultrasound evidence of polycystic ovary syndrome
* stage III-IV endometriosis
* inflammatory or autoimmune disorders
* metabolic disease
* infertility medications (gonadotropins, clomiphene citrate) within the past two months

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: Time Frame: until 12th gestational week
Secondary outcomes:
measure: Implantation rate
timeFrame: Time Frame: until 12th gestational week
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Bioroma
Study officials:
affiliation: Bioroma
name: Mauro Schimberni, MD
role: PRINCIPAL_INVESTIGATOR
References: