Effect of GnRH Antagonist vs Agonist Long on IVF Outcome, Peak Estradiol Level,and Duration of Stimulation

NCT01669291 — Not applicable, Completed, 43 participants, Main Line Fertility Center
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Effect of GnRH Antagonist Protocol vs Agonist Long Protocol During Controlled Hyperstimulation (COH)for Assisted Reproduction on IVF Outcome, Peak Estradiol Level, and Duration of Stimulation.

RegistryNCT01669291
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, single group, masking: none, treatment
Enrollment43 (Actual)
SponsorMain Line Fertility Center (Other); collaborators: Ferring Pharmaceuticals
ConditionsFertility
InterventionsBravelle and Menopur, Agonist, Antagonist (Drug)
Datesstart 2012-07-01, primary completion 2014-05-01, completion 2014-05-01, first posted 2012-08-21, last updated 2014-06-04
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Fertility All trials of Bravelle and Menopur All trials of Agonist

-Summary

The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for assisted reproduction affects IVF outcome, peak estradiol level, and duration of stimulation.

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+Detailed description

No detailed description

+Arms and interventions

ArmTypeInterventionsDescription
Bravelle & Menopur Agonist Long ProtocolActive comparatorDrug: Bravelle and Menopur; Drug: AgonistPatients will use an LH agonist (Lupron) starting on day 18 of the oral contraceptive pill (OCP), 5 units b.i.d. followed by 5 units q.d. beginning on day one of stimulation medications. The 5 units q.d. dose will continue until the day of hCG administration.Patients will administer Bravelle and Menopur for ovarian stimulation.
Bravelle & Menopur Antagonist ProtocolActive comparatorDrug: Bravelle and Menopur; Drug: AntagonistPatients will complete standard dose of oral contraceptive pill (OCP) and will then administer GnRH antagonist (ganirelix acetate or cetrorelix acetate) 0.25 mg q.d. during the stimulation phase when the lead follicle size reaches 12mm. The antagonist will continue until the day of hCG administration. Patients will administer Bravelle and Menopur for ovarian stimulation.
  • Bravelle and Menopur (Drug): Bravelle and Menopur are used for controlled ovarian stimulation (COH)
  • Agonist (Drug), also known as Leuprolide Acetate, Lupron: Agonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges.
  • Antagonist (Drug), also known as ganirelix acetate, cetrorelix acetate: Ganirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges.

+Outcome measures

Primary outcomes

  • To determine if COH in IVF patients using Bravelle & Menopur with antagonists results in improved or equal IVF results compared to patients using agonist. [One year]

Secondary outcomes

  • To determined if COH in IVF patients using Bravelle & Menopur with antagonists results in lower peak estradiol levels compared to agonist [One year]
  • To determine if COH patients using Bravelle & Menopur with antagonist antagonists results inn shorter period of stimulation compared with agonist. [One year]

+Eligibility

Sex: Female, ages: 21 Years to 40 Years, accepts healthy volunteers

Inclusion Criteria:

* Ages 21-40 (inclusive up to 41)
* Day 2-4 FSH < or equal to 10
* Antimullerian Hormone (AMH) greater than or equal to 1.0
* Between 5 and 20 antral follicles on day 2-4
* Body Mass Index (BMI)>or equal to 18 and < or equal to 32

Exclusion Criteria:

* Smokers
* Polycystic Ovarian Disease
* Endometriosis greater than Stage I
* Testicular aspirated sperm

+Locations (1)

FacilityCityCountryStatus
Main Line Fertility CenterBryn Mawr, PennsylvaniaUnited States

+Publications

  • Ludwig, Michael. GnRH antagonists. Textbook of Assisted Reproductive Technologies - Laboratory and Clinical Perspectives. Third edition. Edited by Gardner, D, Weissman, A, Howles, C, Shoham, Z. 2009: 539-552.
  • Ludwig M, Katalinic A, Diedrich K. Use of GnRH antagonists in ovarian stimulation for assisted reproductive technologies compared to the long protocol. Meta-analysis. Arch Gynecol Obstet. 2001 Nov;265(4):175-82. doi: 10.1007/s00404-001-0267-2. PMID 11789740
  • Fluker M, Grifo J, Leader A, Levy M, Meldrum D, Muasher SJ, Rinehart J, Rosenwaks Z, Scott RT Jr, Schoolcraft W, Shapiro DB; North American Ganirelix Study Group. Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation. Fertil Steril. 2001 Jan;75(1):38-45. doi: 10.1016/s0015-0282(00)01638-1. PMID 11163814
  • Ludwig M, Felberbaum RE, Devroey P, Albano C, Riethmuller-Winzen H, Schuler A, Engel W, Diedrich K. Significant reduction of the incidence of ovarian hyperstimulation syndrome (OHSS) by using the LHRH antagonist Cetrorelix (Cetrotide) in controlled ovarian stimulation for assisted reproduction. Arch Gynecol Obstet. 2000 Jul;264(1):29-32. doi: 10.1007/pl00007479. PMID 10985616

+Investigators