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NCT01191710 Clinical Trial

Progesterone Rise in Agonist Versus Antagonist in Vitro Fertilization (IVF) Cycles

Pregnancy Outcome After In Vitro Fertilization (IVF) Clinical Trial

Official title:
Is the Clinical Outcome Affected by the Incidence of Progesterone Elevation on the Day of hCG Triggering When Agonist Protocol is Compared to Antagonist Protocol for IVF

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01191710
Other study ID # ProgRise001
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received August 27, 2010
Last updated September 14, 2010
Start date January 2007
Est. completion date January 2011

Study information
Verified date January 2009
Source Universitair Ziekenhuis Brussel
Contact n/a
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Interventional

Clinical Trial Summary

The aim is to explore whether the incidence of progesterone rise in the late follicular phase differs between GnRH-agonist and GnRH-antagonist protocols for IVF and whether this has an impact on the probability of pregnancy achievement.

Description:

In view of the current debate concerning possible differences in efficacy between the two GnRH analogues, the current study aimed to explore whether progesterone control in the late follicular phase differs when GnRH-agonist is used as compared to GnRH-antagonist and if so to what extend does the progesterone rise have an impact on the probability of achieving a pregnancy.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 39 Years
Eligibility Inclusion Criteria:

- age < 39

- follicle-stimulating hormone (FSH) < 12

- gonadotropin dose 100-300IU

Exclusion Criteria:

- endometriosis

- known endocrine disorder

- blood analyzed in another laboratory

Study Design

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

Related Conditions & MeSH terms

Intervention

Other:
• In vitro fertilization
In vitro fertilization procedure with gonadotropin induced follicular ovarian stimulation

Locations
Country Name City State
Greece Biogenesis Thessaloniki Pylaia

Sponsors (2)
Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel BioGenesis

Country where clinical trial is conducted

Greece, 

References & Publications (1)

Papanikolaou EG, Kolibianakis EM, Pozzobon C, Tank P, Tournaye H, Bourgain C, Van Steirteghem A, Devroey P. Progesterone rise on the day of human chorionic gonadotropin administration impairs pregnancy outcome in day 3 single-embryo transfer, while has no effect on day 5 single blastocyst transfer. Fertil Steril. 2009 Mar;91(3):949-52. Epub 2007 Jun 6. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of late progesterone rise on the day of HCG triggering Up to delivery (2010) No
Secondary Clinical pregnancy rate Delivery rate Up to delivery (2010) No

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