Ulipristal Acetate on Progesterone Levels and Glycodelin-A Endometrial Pattern
NCT ID: NCT01391845
Last Updated: 2011-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
16 participants
INTERVENTIONAL
2011-07-31
2012-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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UPA, 300UI FSH
patients on COS with 300UI FSHu/GnRH Antagonist protocol and ulipristal acetate use
ulipristal acetate
30mg of ulipristal acetate orally the day of hCG injection in a unique dose
No UPA, 300FSH
patients on COS with 300UI FSHu/GnRH Antagonist protocol and without ulipristal acetate use
placebo
placebo orally in a unique dose the day of hCG injection
UPA, FSH 225
patients on COS with 225UI FSHu/GnRH Antagonist protocol and ulipristal acetate use
ulipristal acetate
ulipristal acetate 30mg orally in a unique dose the day of hCG administration
no UPA, FSH225
patients on COS with 225UI FSHu/GnRH Antagonist protocol and without ulipristal acetate use
placebo
placebo orally in a unique dose the day of hCG injection
Interventions
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ulipristal acetate
30mg of ulipristal acetate orally the day of hCG injection in a unique dose
placebo
placebo orally in a unique dose the day of hCG injection
ulipristal acetate
ulipristal acetate 30mg orally in a unique dose the day of hCG administration
placebo
placebo orally in a unique dose the day of hCG injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* FSH on day 3: \<12 UI/ml
* Antral follicular count ≥ 6 on day 3 of the cycle
* BMI: \<30 Kg/m2
Exclusion Criteria
* Hyperprolactinemia
* Kidney or liver disease
* Smoking
* Alcoholism
21 Years
35 Years
FEMALE
Yes
Sponsors
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Programa de Asistencia Reproductiva de Rosario
OTHER
Responsible Party
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Programa de asistencia reproductiva de rosario (PROAR)
Principal Investigators
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Idelma Serpa, MD
Role: PRINCIPAL_INVESTIGATOR
PROAR-IUNIR
Carlos Morente, MD
Role: STUDY_CHAIR
Programa de Asistencia Reproductiva de Rosario
Locations
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PROAR (Programa de Asistencia Reproductiva de Rosario
Rosario, Santa Fe Province, Argentina
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ist1979
Identifier Type: -
Identifier Source: org_study_id
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