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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01669291
Enrollment
43
Registered
2012-08-21
Start date
2012-07-31
Completion date
2014-05-31
Last updated
2014-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fertility

Brief 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.

Detailed description

No detailed description

Interventions

DRUGBravelle and Menopur

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

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

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

Sponsors

Ferring Pharmaceuticals
CollaboratorINDUSTRY
Main Line Fertility Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026