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

This study has been completed.
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01067664
First received: November 1, 2009
Last updated: October 17, 2013
Last verified: June 2013
  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 ] [ 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


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

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 < 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: October 17, 2013
Health Authority: Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on November 20, 2014