Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF

National and Kapodistrian University of Athens

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Infertility

Treatments: Procedure: Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocol; Procedure: GnRH agonist or antagonist protocol without oestradiol pre-treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01798836

030675

Details and patient eligibility

About

To evaluate the effect of oestradiol pre-treatment in a combined ultrashort flare GnRH agonist /GnRH antagonist protocol

Full description

The combined ultrashort flare GnRH agonist /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 is a protocol combining the effect of the microdose flare on endogenous FSH release with the benefit of an immediate LH suppression of the GnRH antagonist.

A major disadvantage of the use of a GnRH antagonist protocol is the limitation for programming cycles, as the drugs administration is started on day 2 of the menstrual cycle and is strictly followed until the hCG criteria are met.

The purpose of the study is to perform oestradiol pre-treatment with the combined ultrashort flare GnRH agonist /GnRH antagonist protocol aiming to

1. better programme an antagonist cycle and
2. improve the IVF outcome parameters, from the production of more follicles / oocytes up to the rise in live birth rates.

Enrollment: 17 patients

Sex: Female

Ages: 25 to 44 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with poor or no response in previous COH for IVF cycles
• Patients with AMH < 1 and/or FSH >12
• Poor quality of embryos in previous cycles
• Age of patients up to 44 years

Exclusion criteria

• Patients with normal ovarian reserve
• Patients with sonographically detected hydrosalpinges
• Presence of intramural fibroid distorting the endometrial cavity or submucous myoma or Asherman's syndrome
• Women with thrombofilia disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Oestradiol and ultrashort GnRH agonist/antagonist protocol

Experimental group

Description:

Women will begin pretreatment with 4 mg/day of 17 β-estradiol before the combination of GnRH ultashort agonist and antagonist protocol

Treatment:

Procedure: Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocol

GnRH agonist or antagonist protocol.

Active Comparator group

Description:

Women will undergo either a conventional short or long GnRH agonist or an antagonist protocol during COH for IVF

Treatment:

Procedure: GnRH agonist or antagonist protocol without oestradiol pre-treatment