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

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

Status
Terminated
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01798836
Enrollment
17
Registered
2013-02-26
Start date
2013-02-28
Completion date
2015-02-28
Last updated
2015-08-06

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

Conditions

Infertility

Keywords

IVF/ICSI cycles, poor responders, ultrashort flare protocol, antagonist protocol

Brief summary

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

Detailed 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.

Interventions

PROCEDUREOestradiol pre-treatment and combination of GnRH agonist/antagonist protocol
PROCEDUREGnRH agonist or antagonist protocol without oestradiol pre-treatment

Sponsors

National and Kapodistrian University of Athens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 44 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rate2 years
Live birth rate2 years

Secondary

MeasureTime frame
Top embryo quality at day 22 years
Biochemical pregnancy2 years
Miscarriage rate2 years
Ectopic pregnancy2 years
Number of oocytes retrieved2 years

Other

MeasureTime frame
Positive Pregnancy Test2 years

Countries

Greece

Outcome results

None listed

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