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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01798836
• Other study ID #: 030675
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: February 20, 2013
• Last updated: August 4, 2015
• Start date: February 2013
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics Committee: Greece
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 44 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

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

• GnRH agonist or antagonist protocol without oestradiol pre-treatment

Locations

Country	Name	City	State
Greece	Assisted Reproduction Unit, 3rd Department of Obstetrics and Gynecology. Attikon University Hospital	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (4)

Bosch E. Can we skip weekends in GnRH antagonist cycles without compromising the final outcome? Fertil Steril. 2012 Jun;97(6):1299-300. doi: 10.1016/j.fertnstert.2012.04.024. — View Citation

Cédrin-Durnerin I, Guivarc'h-Levêque A, Hugues JN; Groupe d'Etude en Médecine et Endocrinologie de la Reproduction. Pretreatment with estrogen does not affect IVF-ICSI cycle outcome compared with no pretreatment in GnRH antagonist protocol: a prospective — View Citation

Griesinger G, Kolibianakis EM, Venetis C, Diedrich K, Tarlatzis B. Oral contraceptive pretreatment significantly reduces ongoing pregnancy likelihood in gonadotropin-releasing hormone antagonist cycles: an updated meta-analysis. Fertil Steril. 2010 Nov;94(6):2382-4. doi: 10.1016/j.fertnstert.2010.04.025. Epub 2010 May 26. — View Citation

Orvieto R, Nahum R, Rabinson J, Gemer O, Anteby EY, Meltcer S. Ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist for patients with repeated IVF failures and poor embryo quality. Fertil Steril. 2009 Apr;91(4 Suppl):1398-400. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Positive Pregnancy Test		2 years	Yes
Primary	Live birth rate		2 years	Yes
Primary	Clinical pregnancy rate		2 years	Yes
Secondary	Number of oocytes retrieved		2 years	No
Secondary	Top embryo quality at day 2		2 years	No
Secondary	Biochemical pregnancy		2 years	No
Secondary	Ectopic pregnancy		2 years	Yes
Secondary	Miscarriage rate		2 years	Yes