Ulipristal Acetate on Progesterone Levels and Glycodelin-A Endometrial Pattern

July 19, 2011 updated by: Programa de Asistencia Reproductiva de Rosario

Effect of Ulipristal Acetate Administration on Serum Progesterone Levels and Glycodelin-A Endometrial Pattern in Women Undergoing Controlled Ovulation Stimulation.

Controlled ovarian stimulation (COS) for FIV increases progesterone (P) and estradiol (E2) serum levels in supraphysiologic concentrations at the end of follicular phase. Elevated serum P levels leads to an accelerated endometrial maturation which interferes with the dialogue between embryo and endometrium. It has been reported that serum progesterone levels ≥ 1.5 ng/ml on the last day of COS are related to a significant decrease in the ongoing pregnancy rate following IVF cycles. Also, it has been reported a significant alteration in the endometrial gene expression profile related to P elevated levels.

Glycodelin-A is an immunomodulatory glycoprotein synthesized by luteal-phase endometrial epithelium and its expression seems to be related to the action of P. Because glycodelin-A has immunosuppressive activity, it may facilitate the process of implantation and the maintenance of pregnancy.

It is already know that ulipristal acetate (UPA) decrease serum P levels. The hypothesis of this study is that UPA is been able to modify P serum levels and glycodelin-A endometrial expression pattern on FSH/GnRH Antagonist cycles for FIV.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Controlled ovarian stimulation (COS) for FIV increases progesterone (P) and estradiol (E2) serum levels in supraphysiologic concentrations at the end of follicular phase. Elevated serum P levels leads to an accelerated endometrial maturation which interferes with the dialogue between embryo and endometrium. It has been reported that serum progesterone levels ≥ 1.5 ng/ml on the last day of COS are related to a significant decrease in the ongoing pregnancy rate following IVF cycles. Also, it has been reported a significant alteration in the endometrial gene expression profile related to P elevated levels.

Glycodelin-A is an immunomodulatory glycoprotein synthesized by luteal-phase endometrial epithelium and its expression seems to be related to the action of P. Because glycodelin-A has immunosuppressive activity, it may facilitate the process of implantation and the maintenance of pregnancy.

Objective: to evaluate the endometrial effect of Progesterone through Glycodelin-A expression pattern on women exposed or not to ulipristal acetate in GnRH Antagonist cycles using two different doses of FSH for ovarian controlled stimulation.

Methods: prospective controlled randomized study. It will be enrolling 16 oocytes donors from Oocyte Donation Program of PROAR (a Reproductive Center of Rosario, Argentina). On day 3 of menstrual cycle FSH serum levels and antral follicular count (AFC) will be measure. If those results fulfill with inclusions criteria, patients will be randomize for FSH 225UI or 300UI GnRH-Antagonist/ urinary FSH protocol. P serum levels will be measure every 48 hours since at least 1 follicle ≥14 mm will be achieve until at least 1 follicle reach 19mm of diameter. The next day of hCG administration a new P circulating will be measure and then the patient will be randomize trough opaque envelopes for receive 30mg of ulipristal acetate or placebo. An endometrial biopsy with Cornier´s Pipelle will be performing 3 and 5 days after hCG injection (hCG+3 and hCG+5 days) to evaluate endometrial dating and Glycodelin-A expression pattern.

Statistical analysis: nominal variables will be analyzing using t-Student test and the effect of ulipristal with ANOVA.

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • PROAR (Programa de Asistencia Reproductiva de Rosario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age <35 years old
  • FSH on day 3: <12 UI/ml
  • Antral follicular count ≥ 6 on day 3 of the cycle
  • BMI: <30 Kg/m2

Exclusion Criteria:

  • Hypothyroidism
  • Hyperprolactinemia
  • Kidney or liver disease
  • Smoking
  • Alcoholism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UPA, 300UI FSH
patients on COS with 300UI FSHu/GnRH Antagonist protocol and ulipristal acetate use
Drug: ulipristal acetate
30mg of ulipristal acetate orally the day of hCG injection in a unique dose
Other Names:
  • UPA/FSH 300
Drug: ulipristal acetate
ulipristal acetate 30mg orally in a unique dose the day of hCG administration
Other Names:
  • UPA/FSH225
Placebo Comparator: No UPA, 300FSH
patients on COS with 300UI FSHu/GnRH Antagonist protocol and without ulipristal acetate use
Drug: placebo
placebo orally in a unique dose the day of hCG injection
Other Names:
  • no UPA/FSH225
Experimental: UPA, FSH 225
patients on COS with 225UI FSHu/GnRH Antagonist protocol and ulipristal acetate use
Drug: ulipristal acetate
30mg of ulipristal acetate orally the day of hCG injection in a unique dose
Other Names:
  • UPA/FSH 300
Drug: ulipristal acetate
ulipristal acetate 30mg orally in a unique dose the day of hCG administration
Other Names:
  • UPA/FSH225
Placebo Comparator: no UPA, FSH225
patients on COS with 225UI FSHu/GnRH Antagonist protocol and without ulipristal acetate use
Drug: placebo
placebo orally in a unique dose the day of hCG injection
Other Names:
  • no UPA/FSH225

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Glycodelin-A endometrial expression pattern and Progesterone serum levels in women expose to ulipristal acetate on stimulated ovarian cycles for FIV
Time Frame: participants will be followed for the duration of one mesntrual cycle, from day 1 of the cycle until day 28-32
to evaluate Glycodelin-A expression pattern by immunohistochemistry and Progesterone serum levels on women exposed or not to ulipristal acetate in FSH/GnRH Antagonist protocol.
participants will be followed for the duration of one mesntrual cycle, from day 1 of the cycle until day 28-32

Secondary Outcome Measures

Outcome Measure
Time Frame
P levels during controlled ovarian stimulation since at least one follicle achieve ≥14mm of diameter
Time Frame: participants will be followed for the duration of one mesntrual cycle,from day 1 until day 28-32
participants will be followed for the duration of one mesntrual cycle,from day 1 until day 28-32
Serum P levels on two different doses of FSH in a GnRH Antagonist protocol for ovarian stimulation
Time Frame: participants will be followed for the duration of one mesntrual cycle,from day 1 until day 28-32
participants will be followed for the duration of one mesntrual cycle,from day 1 until day 28-32
Glycodelin-A endometrial expression pattern on two different doses of FSH in a GnRH Antagonist protocol for ovarian stimulation
Time Frame: participants will be followed for the duration of one mesntrual cycle, from day 1 until day 28-32
participants will be followed for the duration of one mesntrual cycle, from day 1 until day 28-32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Programa de Asistencia Reproductiva de Rosario

Investigators

  • Principal Investigator: Idelma Serpa, MD, PROAR-IUNIR
  • Study Chair: Carlos Morente, MD, Programa de Asistencia Reproductiva de Rosario

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

June 28, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ist1979

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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