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

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ClinicalTrials.gov Identifier: NCT02070198
Recruitment Status : Unknown
Verified February 2014 by Bioroma.
Recruitment status was:  Recruiting
First Posted : February 25, 2014
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):
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 .


Condition or disease Intervention/treatment Phase
Female Infertility Poor Responder Drug: Long acting FSH and GnRH antagonist Drug: Daily FSH and GnRH antagonist Drug: Triptorelin and recombinant FSH Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : December 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: 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.

Experimental: 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.
Drug: 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.

Experimental: 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.
Drug: 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 untill the day of HCG administration.




Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: Time Frame: until 12th gestational week ]

Secondary Outcome Measures :
  1. Implantation rate [ Time Frame: Time Frame: until 12th gestational week ]


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Ages Eligible for Study:   25 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070198


Contacts
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Contact: Mauro Schimberni, MD +39063334266 bioroma@bioroma.net

Locations
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Italy
Bioroma Recruiting
Rome, Italy, 00197
Contact: Mauro Schimberni    +39063334266    bioroma@bioroma.net   
Principal Investigator: Mauro Schimberni         
Sponsors and Collaborators
Bioroma
Investigators
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Principal Investigator: Mauro Schimberni, MD Bioroma

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Responsible Party: Bioroma
ClinicalTrials.gov Identifier: NCT02070198     History of Changes
Other Study ID Numbers: BRM001
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014

Keywords provided by Bioroma:
Poor responders, IVF, GnRH agonist, GnRH antagonist, recombinant FSH

Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Prolactin Release-Inhibiting Factors
Triptorelin Pamoate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents