Ultrashort GnRH Agonist/Antagonist Versus GnRH Antagonist IVF

Sheba Medical Center

Status and phase: Unknown; Phase 2

Conditions: Infertility

Treatments: Other: ARM A- Agonist/Antagonist protocol; Other: ARM B- Antagonist protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT02173977

SHEBA-14-1078-RO-CTIL

Details and patient eligibility

About

The purpose of this study is to evaluate the appropriate controlled ovarian hyperstimulation (COH) protocol in good prognosis patients undergoing IVF treatment. The stimulation characteristics of cycles which include ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist will be compared to the flexible multidose GnRH antagonist protocol.

The investigators hypothesized that combining the stimulatory effect of GnRH agonists and immediate suppression of the GnRH antagonist in a unique protocol may be a valuable new COH strategy for IVF patients, resulting in improved ART outcome.

Full description

The ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist protocol during COH cycle resulted in a significantly higher clinical pregnancy rate in patients with poor embryo quality, with repeated IVF failures and in poor responders. This protocol combines the effect of the microdose flare on endogenous follicle stimulating hormone (FSH) release with the benefit of an immediate luteinizing hormone suppression of the GnRH antagonist.

The basic hypothesis of this approach can also benefit IVF patients with good prognosis without compromising the ability to use gonadotrophin-releasing hormone (GnRH) agonist to effectively trigger ovulation, while completely eliminating any threat of clinically significant ovarian hyperstimulation syndrome (OHSS).

The purpose of the study is to compare cycles consisting of ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist with those using the flexible multidose GnRH antagonist protocol

1. To compare the IVF outcome variables and ongoing pregnancy rates.

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Up to three previous IVF attempts

Exclusion criteria

• Patients with poor or no response in previous COH for IVF cycles
• Abnormal ovarian reserve test i.e. anti-mullerian hormone (AMH), Antral follicle test
• Risk factor for Diminished Ovarian Reserve

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

ARM A- Agonist/Antagonist protocol

Active Comparator group

Description:

The Ultrashort GnRH Agonist/antagonist method entails pre-treatment with oral contraceptive pills before the combination of GnRH ultrashort agonist and antagonist protocol

Treatment:

Other: ARM B- Antagonist protocol

Other: ARM A- Agonist/Antagonist protocol

ARM B- Antagonist protocol

Active Comparator group

Description:

The standard IVF method entails Flexible Multidose GnRH Antagonist protocol during COH

Treatment:

Other: ARM B- Antagonist protocol

Other: ARM A- Agonist/Antagonist protocol