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

NCT ID: NCT01669291

Last Updated: 2014-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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No detailed description

Conditions

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Fertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bravelle & Menopur Agonist Long Protocol

Patients 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.

Group Type ACTIVE_COMPARATOR

Bravelle and Menopur

Intervention Type DRUG

Bravelle and Menopur are used for controlled ovarian stimulation (COH)

Agonist

Intervention Type DRUG

Agonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges.

Bravelle & Menopur Antagonist Protocol

Patients 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.

Group Type ACTIVE_COMPARATOR

Bravelle and Menopur

Intervention Type DRUG

Bravelle and Menopur are used for controlled ovarian stimulation (COH)

Antagonist

Intervention Type DRUG

Ganirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges.

Interventions

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Bravelle and Menopur

Bravelle and Menopur are used for controlled ovarian stimulation (COH)

Intervention Type DRUG

Agonist

Agonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges.

Intervention Type DRUG

Antagonist

Ganirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges.

Intervention Type DRUG

Other Intervention Names

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Leuprolide Acetate Lupron ganirelix acetate cetrorelix acetate

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Main Line Fertility Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael J Glassner, M.D.

Role: PRINCIPAL_INVESTIGATOR

Main Line Fertility Center

Sharon H. Anderson, Ph.D

Role: STUDY_DIRECTOR

Main Line Fertility Center

Locations

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Main Line Fertility Center

Bryn Mawr, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 11789740 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11163814 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10985616 (View on PubMed)

Other Identifiers

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MLFC-003

Identifier Type: -

Identifier Source: org_study_id

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