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Trial record 81 of 422 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

EXpression PRofile Endometrium Samples Study (EXPRESS)

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ClinicalTrials.gov Identifier: NCT01210144
Recruitment Status : Terminated (Study terminated due to recruitment failure)
First Posted : September 28, 2010
Results First Posted : November 14, 2012
Last Update Posted : December 27, 2013
Sponsor:
Collaborator:
Merck Serono S.A.S, France
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Brief Summary:

This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the gene expression profiles and histologic changes of the endometrial tissue before and after stimulation with Gonal-f®. Physicians are interested in identifying predictive genetic markers in assisted reproductive technologies (ART) in addition to the clinical predictive factors already known. Among those predictive factors, the state of the endometrium is considered as an important implantation determining factor for which pharmacogenomic research is of great interest.

The direct benefits of this study will be to know whether the endometrial gene expression profile is modified in response to stimulation treatment and have an impact or not on the endometrial tissue receptivity. The potential benefits of this study could be to assess the therapy optimization based on individual treatment response and gene expression profile compared to group treatment response in infertile women and prediction of response to therapy based on gene expression profiling before and after Gonal-f® stimulation in infertile women.


Condition or disease Intervention/treatment Phase
In Vitro Fertilization Drug: Gonal -f® [r-hFSH] Drug: Ovitrelle® [r-hCG alfa] Drug: Gonadotropin-releasing hormone (GnRH) Agonist Drug: Gonadotropin-releasing hormone (GnRH) Antagonist Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Pilot Study on Gene Expression Profiling of the Endometrial Tissue in Patients Undergoing Assisted Reproductive Technology [ART: In Vitro Fertilization (IVF)/ Intracytoplasmic Sperm Injection (ICSI)] With GONAL-f®
Study Start Date : August 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gonal-f® + Ovitrelle® + Long Agonist Protocol Drug: Gonal -f® [r-hFSH]
On Day 2 of the menstrual cycle, a pre-defined fixed dose of 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH) will be administered until follicles are recruited and developed.
Other Names:
  • Gonal-f®
  • Follitropin Alfa

Drug: Ovitrelle® [r-hCG alfa]
Ovulation triggering will be performed using a single injection of 250 microgram (mcg) recombinant human chorionic gonadotropin (r-hCG) alfa as soon as follicles satisfy the criteria for follicular development, that is at least 3 follicles greater than (>) 16 millimeter (mm), and with estradiol (E2) > 1 microgram per liter (mcg/L) if gonadotropin releasing hormone (GnRH) agonist will be used.
Other Names:
  • Ovitrelle®
  • Ovidrel®

Drug: Gonadotropin-releasing hormone (GnRH) Agonist
To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily will be given after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.

Experimental: Gonal-f® + Ovitrelle® + Multi-dose Antagonist Protocol Drug: Gonal -f® [r-hFSH]
On Day 2 of the menstrual cycle, a pre-defined fixed dose of 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH) will be administered until follicles are recruited and developed.
Other Names:
  • Gonal-f®
  • Follitropin Alfa

Drug: Ovitrelle® [r-hCG alfa]
Ovulation triggering will be performed using a single injection of 250 microgram (mcg) recombinant human chorionic gonadotropin (r-hCG) alfa as soon as follicles satisfy the criteria for follicular development, that is at least 3 follicles greater than (>) 16 millimeter (mm), and with estradiol (E2) > 1 microgram per liter (mcg/L) if gonadotropin releasing hormone (GnRH) agonist will be used.
Other Names:
  • Ovitrelle®
  • Ovidrel®

Drug: Gonadotropin-releasing hormone (GnRH) Antagonist
To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily will be given from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.




Primary Outcome Measures :
  1. Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® [ Time Frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® ]
    A list of genes based on gene expression profiling carried out on ribonucleic acid (RNA) extracted from endometrial tissue. The expression of messenger ribonucleic acid (mRNA) in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.

  2. Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® [ Time Frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® ]
    Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle) and Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).


Secondary Outcome Measures :
  1. Gene Expression of the Endometrium in Participants With or Without Blastocyst Transfer [ Time Frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® ]
    A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.

  2. Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® in Participants Having Undergone Agonist or Antagonist Protocol [ Time Frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® ]
    A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.

  3. Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® and Having Undergone Agonist or Antagonist Protocol [ Time Frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® ]
    Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).

  4. Gene Expression in Participants Without Blastocyst Transfer [ Time Frame: Day 5 or 6 (window of implantation) after Oocyte Retrieval ]
    A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.

  5. Number of Participants With a Specific Histological Pattern of the Endometrium in Participants Without Blastocyst Transfer [ Time Frame: Day 5 or 6 (window of implantation) after Oocyte Retrieval ]
    Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).

  6. Gene Expression in Participants With Good or Poor Response to Gonal-f® [ Time Frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® ]
    A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent. Participants with poor response: 5 mature oocytes or less; participants with good response: more than 8 mature oocytes.

  7. Number of Participants With a Specific Histological Pattern of the Endometrium in Participants With Good or Poor Response to Gonal-f® [ Time Frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® ]
    Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase). Participants with poor response: 5 mature oocytes or less; participants with good response: more than 8 mature oocytes.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infertile female or infertile male. Infertile female means diverse infertility etiologies including tubal disease (excepting hydrosalpinx) and so called "unexplained infertility"
  • Suitable for ART: IVF undergoing first or second attempt, ICSI undergoing first attempt
  • 18-35 years old, body mass index (BMI) less than or equal to 27 kilogram per square meter (kg/m^2), non smoking
  • Normal ovarian status (FSH less than or equal to 9.45 International Units per Liter [IU/L], E2 less than or equal to 40 picogram per milliliter [pg/mL], Anti-Mullerian Hormone [AMH] greater than or equal to 18 picomole/liter [pmol/L]; within normal laboratory range values, normal ovaries sonography and uterine echo doppler)
  • No history of active genito-urinary infection
  • Normal thyroid function (or adequate substitution for at least 3 months)
  • Negative cervical papanicolaou test within the last 12 months prior to study entry
  • No hormonal therapy, including gonadotropins and progesterone, for at least 2 months prior to the study
  • In couple with female infertility, male partner with normal sperm or moderate oligoasthenospermia in semen analysis and negative semen culture less than 6 months at the study entry
  • Willingness and ability to comply with the protocol for the duration of the study
  • Written informed consent prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care

Exclusion Criteria:

  • Subjects with ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term
  • Subjects with uterine malformation, diethylstilbestrol syndrome, adenomyosis, synechia
  • Subjects with history of previous OHSS
  • Subjects with polycystic ovarian syndrome (PCOS) according to the revised Rotterdam Consensus 2003
  • Subjects with extra-uterine pregnancy during the previous 3 months
  • Subjects with recurrent miscarriages (early or late, more than 2)
  • Subjects having known infection with human immunodeficiency virus (HIV), hepatitis B or C virus, for subject or partner
  • Subjects with abnormal gynecological bleeding of undetermined origin
  • Subjects with history of major thromboembolic disease
  • Subjects with endometriosis
  • Subjects with presence or history of malignant tumors and related treatment
  • Subjects with clinically significant systemic disease or clinically significant abnormal hematology, chemistry, or urinalysis results at screening
  • Subjects with known allergy or hypersensitivity to Gonal-f® or Ovitrelle®
  • Subjects with any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years
  • Subjects who have participated within 3 months prior to study entry in another clinical trial

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): NCT01210144


Locations
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France
Research Site
Paris, France
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Merck Serono S.A.S, France

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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01210144     History of Changes
Other Study ID Numbers: IMP 28364
2007-003938-41 ( EudraCT Number )
First Posted: September 28, 2010    Key Record Dates
Results First Posted: November 14, 2012
Last Update Posted: December 27, 2013
Last Verified: December 2013
Keywords provided by Merck KGaA, Darmstadt, Germany:
Infertility
Gonal-f
gene expression
Assisted Reproductive Technologies
Follitropin alfa
endometrium
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Hormones
Prolactin Release-Inhibiting Factors
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents