Text Size

Prognostic Value of Progesterone for In Vitro Fertilization (IVF) Outcome (PROG2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Aristotle University Of Thessaloniki.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01067664
First received: November 1, 2009
Last updated: February 10, 2010
Last verified: November 2009
History of Changes
  Purpose

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.


Condition
Subfertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Clinical pregnancy, defined as ultrasound evidence of fetal heart activity at 6-8 weeks of gestation [ Time Frame: At 6-8 weeks of gestation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy (defined as a b-hCG> 25 IU/L) [ Time Frame: 12 days after embryo transfer ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

6ml of serum will be frozen and stored for later analysis in batch


Estimated Enrollment: 130
Study Start Date: May 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients undergoing IVF with rFSH and GnRH antagonists

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women undergoing ovarian stimulation with the use of rFSH and GnRH antagonists for in-vitro fertilization.

Criteria

Inclusion Criteria:

  • Age < 40 years
  • Basal FSH < 10 IU/L
  • Basal P < 1.6 ng/mL

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067664

Contacts
Contact: Basil C Tarlatzis, MD, PhD +30 2310 693131 tarlatzis@gmail.com
Contact: Christos A Venetis, MD, MSc +30 2310 693390 venetis@gmail.com

Locations
Greece
Unit for Human Reproduction, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki Recruiting
Thessaloniki, Greece
Contact: Basil C Tarlatzis, MD, MSc     +30 2310 693131     tarlatzis@gmail.com    
Contact: Christos A Venetis, MD, MSc     +2310 693390     venetis@gmail.com    
Principal Investigator: Basil C Tarlatzis, MD, PhD            
Sub-Investigator: Christos A Venetis, MD, MSc            
Sub-Investigator: Efstratios M Kolibianakis, MD, MSc, PhD            
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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
  More Information

No publications provided

Responsible Party: Basil C. Tarlatzis, MD, PhD, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
ClinicalTrials.gov Identifier: NCT01067664     History of Changes
Other Study ID Numbers: UHR-7
Study First Received: November 1, 2009
Last Updated: February 10, 2010
Health Authority: Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Progesterone
Progestins
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013