Prognostic Value of Progesterone for In Vitro Fertilization (IVF) Outcome
PROG2
The Effect of Serum Progesterone Levels on the Day of hCG Administration on the Probability of Pregnancy in Patients Treated by IVF Using GnRH Antagonists and Recombinant Gonadotrophins
1 other identifier
observational
130
1 country
1
Brief Summary
This observational study attempts to investigate the potential role of serum progesterone levels on the day of hCG administration (thus, the end of the follicular phase) on the probability of pregnancy, in patients undergoing IVF with the use of GnRH antagonists and recombinant gonadotrophins. There has been evidence, that increased serum levels of progesterone are associated with a decreased probability of pregnancy after IVF. This study will attempt to explore the role of progesterone on the outcome of IVF, by closely monitoring its levels during the late follicular phase.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 1, 2009
CompletedFirst Posted
Study publicly available on registry
February 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedOctober 18, 2013
June 1, 2013
4.1 years
November 1, 2009
October 17, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy, defined as ultrasound evidence of fetal heart activity at 6-8 weeks of gestation
At 6-8 weeks of gestation
Secondary Outcomes (1)
Pregnancy (defined as a b-hCG> 25 IU/L)
12 days after embryo transfer
Study Arms (1)
Patients undergoing IVF with rFSH and GnRH antagonists
Eligibility Criteria
Women undergoing ovarian stimulation with the use of rFSH and GnRH antagonists for in-vitro fertilization.
You may qualify if:
- Age \< 40 years
- Basal FSH \< 12 IU/L
- Basal P \< 1.6 ng/mL
You may not qualify if:
- Presence of cystic formations at the ovaries during the basal ultrasound scan (prior the initiation of stimulation)
- Women with polycystic ovaries syndrome (PCOS)
- Women with Stage III-IV Endometriosis
- Women with a pathological condition of the adrenal glands
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unit for Human Reproduction, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
Thessaloniki, Greece
Biospecimen
6ml of serum will be frozen and stored for later analysis
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Basil C Tarlatzis, MD, PhD
1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
- PRINCIPAL INVESTIGATOR
Christos A Venetis, MD, MSc
Unit for Human Reproduction, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 1, 2009
First Posted
February 11, 2010
Study Start
May 1, 2009
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
October 18, 2013
Record last verified: 2013-06