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

Subfertility Clinical Trial

— PROG2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067664
• Other study ID #: UHR-7
• Status: Completed
• Phase: N/A
• First received: November 1, 2009
• Last updated: October 17, 2013
• Start date: May 2009
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Subfertility

Locations

Country	Name	City	State
Greece	Unit for Human Reproduction, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy, defined as ultrasound evidence of fetal heart activity at 6-8 weeks of gestation		At 6-8 weeks of gestation	No
Secondary	Pregnancy (defined as a b-hCG> 25 IU/L)		12 days after embryo transfer	No