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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01067664
First Posted: February 11, 2010
Last Update Posted: October 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Aristotle University Of Thessaloniki
  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:


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 ]

Secondary Outcome Measures:
  • Pregnancy (defined as a b-hCG> 25 IU/L) [ Time Frame: 12 days after embryo transfer ]

Biospecimen Retention:   Samples Without DNA
6ml of serum will be frozen and stored for later analysis

Enrollment: 130
Study Start Date: May 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients undergoing IVF with rFSH and GnRH antagonists

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes 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 < 12 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067664


Locations
Greece
Unit for Human Reproduction, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
Thessaloniki, Greece
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

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
First Submitted: November 1, 2009
First Posted: February 11, 2010
Last Update Posted: October 18, 2013
Last Verified: June 2013

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