Long Acting FSH Plus Antagonist Versus Daily FSH Plus Antagonist Versus Short Agonist Protocol in Poor Responders Undergoing IVF

Phase 4

• Conditions: Female Infertility; Poor Responder
• Interventions: Drug: Long acting FSH and GnRH antagonist; Drug: Daily FSH and GnRH antagonist; Drug: Triptorelin and recombinant FSH

• Registration Number: NCT02070198
• Lead Sponsor: Bioroma

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-02
• Study First Submitted: 2014-02-20
• Study First Submitted QC: 2014-02-21
• Last Update Submitted: 2014-02-21
• Study First Posted: 2014-02-25
• Last Update Posted: 2014-02-25
• Primary Completion: 2014-11
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long acting FSH and GnrH antagonist	Long acting FSH and GnRH antagonist	Woman in long acting FSH and GnRH antagonist arm receive an initial dose of 150 mcg Corifollitropin alfa on second day of the menstrual cycle followed by a fixed daily dose of 0.25 mg of GnRH antagonist on day 7 of the cycle onwards. On the ninth day of the cycle, a daily fixed dose of 300 IU of recombinant FSH will be administered until the day of ovulation triggering.
daily FSH and GnRH antagonist	Daily FSH and GnRH antagonist	Woman in daily FSH and GnRH antagonist arm receive a fixed dose of 300 IU of recombinantFSH starting 3 day of the menstrual cycle followed by a fixed daily dose of 0.25 mg of GnRH antagonist on day 7 of the cycle onwards until the day of ovulation triggering.
Triptorelin and recombinant FSH	Triptorelin and recombinant FSH	Women in triptorelin and recombinant FSH arm receive a fixed dose of 0.05 mg of triprorelin from the 1 day of the menstrual cycle followed by a fixed dose of 300 IU of recombinant FSH starting 3 day until the day of HCG administration.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	Time Frame: until 12th gestational week

Secondary Outcome Measures

Name	Time	Method
Implantation rate	Time Frame: until 12th gestational week

Trial Locations

Locations (1)

Bioroma; 🇮🇹 Rome, Italy