InfertilityNCT01391845
Ulipristal Acetate on Progesterone Levels and Glycodelin-A Endometrial Pattern
A study testing ulipristal acetate in people with Infertility, run by Programa de Asistencia Reproductiva de Rosario at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- ulipristal acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteArgentina
- Study dates
- Jul 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Hypothyroidism
- Hyperprolactinemia
- Kidney or liver disease
- Smoking
- Alcoholism
Trial locations and contacts
1 site in 1 country.
Idelma Serpa, MD contact
Argentina1 site
PROAR (Programa de Asistencia Reproductiva de Rosario
Rosario, Santa Fe Province, 2000
Idelma Serpa, MD, +54 0341 155668963, idelmaserpa@yahoo.com.ar
About this study
Official title: 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.
Read the 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.
- Conditions
- Infertility
- Being tested
- ulipristal acetate, placebo
- Keywords
- progesterone, glycodelin-A, ulipristal acetate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ulipristal acetateDrug
Also called UPA/FSH 300
30mg of ulipristal acetate orally the day of hCG injection in a unique dose
placeboDrug
Also called No UPA/FSH 300
placebo orally in a unique dose the day of hCG injection
ulipristal acetateDrug
Also called UPA/FSH225
ulipristal acetate 30mg orally in a unique dose the day of hCG administration
placeboDrug
Also called no UPA/FSH225
placebo orally in a unique dose the day of hCG injection
| Study group | Role | What they receive |
|---|---|---|
| UPA, 300UI FSH | Experimental | patients on COS with 300UI FSHu/GnRH Antagonist protocol and ulipristal acetate use Receives: Drug: ulipristal acetate |
| No UPA, 300FSH | Placebo comparator | patients on COS with 300UI FSHu/GnRH Antagonist protocol and without ulipristal acetate use Receives: Drug: placebo |
| UPA, FSH 225 | Experimental | patients on COS with 225UI FSHu/GnRH Antagonist protocol and ulipristal acetate use Receives: Drug: ulipristal acetate |
| no UPA, FSH225 | Placebo comparator | patients on COS with 225UI FSHu/GnRH Antagonist protocol and without ulipristal acetate use Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Glycodelin-A endometrial expression pattern and Progesterone serum levels in women expose to ulipristal acetate on stimulated ovarian cycles for FIV
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.
Measured: participants will be followed for the duration of one mesntrual cycle, from day 1 of the cycle until day 28-32
Secondary outcomes (3)
P levels during controlled ovarian stimulation since at least one follicle achieve ≥14mm of diameter
Measured: 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
Measured: 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
Measured: participants will be followed for the duration of one mesntrual cycle, from day 1 until day 28-32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Programa de Asistencia Reproductiva de Rosario
- Sponsor type
- University, hospital or other
- Investigators
- Idelma Serpa, MD, Principal investigator, PROAR-IUNIRCarlos Morente, MD, Study chair, Programa de Asistencia Reproductiva de Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391845
- Sponsor's protocol ID
- ist1979
- Status last verified
- May 2011
- First submitted
- 28 Jun 2011
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ulipristal Acetate Administration on Serum Progesterone Levels and Glycodelin-A Endometrial Pattern in Women Undergoing Controlled Ovulation Stimulation.
- ClinicalTrials.gov ID
- NCT01391845
- Acronym / sponsor ID
- ist1979
- Conditions
- Infertility
- Keywords
- progesterone, glycodelin-A, ulipristal acetate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Programa de Asistencia Reproductiva de RosarioUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| UPA, 300UI FSH | Experimental | Drug: ulipristal acetatepatients on COS with 300UI FSHu/GnRH Antagonist protocol and ulipristal acetate use |
| No UPA, 300FSH | Placebo comparator | Drug: placebopatients on COS with 300UI FSHu/GnRH Antagonist protocol and without ulipristal acetate use |
| UPA, FSH 225 | Experimental | Drug: ulipristal acetatepatients on COS with 225UI FSHu/GnRH Antagonist protocol and ulipristal acetate use |
| no UPA, FSH225 | Placebo comparator | Drug: placebopatients on COS with 225UI FSHu/GnRH Antagonist protocol and without ulipristal acetate use |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Hypothyroidism
- Hyperprolactinemia
- Kidney or liver disease
- Smoking
- Alcoholism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ulipristal acetateAlso: UPA/FSH 30030mg of ulipristal acetate orally the day of hCG injection in a unique dose | Drug | UPA, 300UI FSH |
| placeboAlso: No UPA/FSH 300placebo orally in a unique dose the day of hCG injection | Drug | No UPA, 300FSH |
| ulipristal acetateAlso: UPA/FSH225ulipristal acetate 30mg orally in a unique dose the day of hCG administration | Drug | UPA, FSH 225 |
| placeboAlso: no UPA/FSH225placebo orally in a unique dose the day of hCG injection | Drug | no UPA, FSH225 |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Idelma Serpa, MD contact
Idelma Serpa, MD principal investigator
PROAR-IUNIR
Carlos Morente, MD study chair
Programa de Asistencia Reproductiva de Rosario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ulipristal acetate in people with Infertility, run by Programa de Asistencia Reproductiva de Rosario at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Idelma Serpa, MD (+54 0341 155668963, idelmaserpa@yahoo.com.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2011.