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

NCT02070198 | Unknown Phase 4 DMC

• 1 other identifier: BRM001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 .

Conditions

Female Infertility; Poor Responder

Keywords

Poor responders, IVF, GnRH agonist, GnRH antagonist, recombinant FSH

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Time Frame: until 12th gestational week

Secondary Outcomes (1)

• Implantation rate

  Time Frame: until 12th gestational week

Study Arms (3)

Long acting FSH and GnrH antagonist

EXPERIMENTAL

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

daily FSH and GnRH antagonist

EXPERIMENTAL

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

Triptorelin and recombinant FSH

EXPERIMENTAL

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

Interventions

Long acting FSH and GnRH antagonist DRUG

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.

Long acting FSH and GnrH antagonist

Daily FSH and GnRH antagonist DRUG

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.

daily FSH and GnRH antagonist

Triptorelin and recombinant FSH DRUG

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.

Triptorelin and recombinant FSH

Eligibility Criteria

• Age: 25 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioroma: lead

Study Sites (1)

Bioroma

Rome, Italy, 00197, Italy

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Mauro Schimberni, MD

  Bioroma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauro Schimberni, MD

CONTACT

+39063334266; bioroma@bioroma.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 25, 2014
• Study Start: December 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

IT (1)