We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ulipristal Acetate on Progesterone Levels and Glycodelin-A Endometrial Pattern

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.
ClinicalTrials.gov Identifier: NCT01391845
Recruitment Status : Unknown
Verified May 2011 by Programa de Asistencia Reproductiva de Rosario.
Recruitment status was:  Not yet recruiting
First Posted : July 12, 2011
Last Update Posted : July 20, 2011
Sponsor:
Information provided by:
Programa de Asistencia Reproductiva de Rosario

Brief Summary:

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.


Condition or disease Intervention/treatment
Infertility Drug: ulipristal acetate Drug: placebo

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  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Effect of Ulipristal Acetate Administration on Serum Progesterone Levels and Glycodelin-A Endometrial Pattern in Women Undergoing Controlled Ovulation Stimulation.
Study Start Date : July 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: UPA/FSH 300
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 Name: No UPA/FSH 300
Experimental: UPA, FSH 225
patients on COS with 225UI FSHu/GnRH Antagonist protocol and ulipristal acetate use
Drug: ulipristal acetate
ulipristal acetate 30mg orally in a unique dose the day of hCG administration
Other Name: 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 Name: no UPA/FSH225



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01391845


Contacts
Contact: Idelma Serpa, MD +54 0341 155668963 idelmaserpa@yahoo.com.ar
Contact: Idelma Serpa, MD idelmaserpa@yahoo.com.ar

Locations
Argentina
PROAR (Programa de Asistencia Reproductiva de Rosario Not yet recruiting
Rosario, Santa Fe, Argentina, 2000
Contact: Idelma Serpa, MD    +54 0341 155668963    idelmaserpa@yahoo.com.ar   
Sponsors and Collaborators
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

Responsible Party: Idelma Serpa, Programa de asistencia reproductiva de rosario (PROAR)
ClinicalTrials.gov Identifier: NCT01391845     History of Changes
Other Study ID Numbers: ist1979
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: May 2011

Keywords provided by Programa de Asistencia Reproductiva de Rosario:
progesterone
glycodelin-A
ulipristal acetate

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