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Trial · Interventional

TerminatedPhase 4Results postedRegistry data

EXpression PRofile Endometrium Samples Study

Short name EXPRESS

NCTNCT01210144 (opens ClinicalTrials.gov in a new tab)Other idIMP 28364Other id2007-003938-41

This trial does not test a peptide that PepBank tracks.

  • Names hCG (human chorionic gonadotropin), does not test it. It appears in the description.

Overview

Status
Terminated
Phase
Phase 4
Enrollment
27 participants (actual)
Sponsor
Merck KGaA, Darmstadt, Germany · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

France

Start
Aug 2008
Primary completion
Aug 2010
Completion
Aug 2010
First posted
28 Sept 2010 (estimated)
Last update posted
27 Dec 2013 (estimated)
Conditions
In Vitro Fertilization

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2008200920102011
  1. Ph 4

    EXPRESS

    NCT01210144

    Aug 2008 to Aug 2010

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Gonal -f® [r-hFSH]Drug
  • Ovitrelle® [r-hCG alfa]Drug
  • Gonadotropin-releasing hormone (GnRH) AgonistDrug
  • Gonadotropin-releasing hormone (GnRH) AntagonistDrug

Arms2

  • Experimental

    Gonal-f® + Ovitrelle® + Long Agonist Protocol

  • Experimental

    Gonal-f® + Ovitrelle® + Multi-dose Antagonist Protocol

Primary outcomes2

Outcomes the sponsor listed as primary.

  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®

    Registry description

    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®

    Registry description

    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 outcomes(7)
  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®

    Registry description

    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®

    Registry description

    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®

    Registry description

    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

    Registry description

    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

    Registry description

    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®

    Registry description

    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®

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®

Gene Expression of the Endometrium Following 1 Cycle With Gonal-f®

GroupValue
Gonal-f® + Ovitrelle®not posted
Primary outcomeNumber· Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®

Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f®

GroupValue (participants)
Gonal-f® + Ovitrelle®2
Secondary and other outcome results(6)
Secondary outcome· Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®

Gene Expression of the Endometrium in Participants With or Without Blastocyst Transfer

GroupValue
Gonal-f® + Ovitrelle® (Long Agonist Protocol)not posted
Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)not posted
Secondary outcome· Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®

Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® in Participants Having Undergone Agonist or Antagonist Protocol

GroupValue
Gonal-f® + Ovitrelle® (Long Agonist Protocol)not posted
Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)not posted
Secondary outcomeNumber· Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®

Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® and Having Undergone Agonist or Antagonist Protocol

GroupValue (participants)
Gonal-f® + Ovitrelle® (Long Agonist Protocol)1
Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)1
Secondary outcome· Day 5 or 6 (window of implantation) after Oocyte Retrieval

Gene Expression in Participants Without Blastocyst Transfer

GroupValue
Gonal-f® + Ovitrelle® (Long Agonist Protocol)not posted
Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)not posted
Secondary outcomeNumber· Day 5 or 6 (window of implantation) after Oocyte Retrieval

Number of Participants With a Specific Histological Pattern of the Endometrium in Participants Without Blastocyst Transfer

GroupValue (participants)
Gonal-f® + Ovitrelle® (Long Agonist Protocol)0
Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)not posted
Secondary outcome· Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®

Gene Expression in Participants With Good or Poor Response to Gonal-f®

GroupValue
Gonal-f® + Ovitrelle® (Long Agonist Protocol)not posted
Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Gonal-f® + Ovitrelle® (Long Agonist Protocol)Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than \[\>\] 16 millimeter \[mm\], and with estradiol \[E2\] \>1 microgram per liter \[mcg/L\]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started 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.–0 / 132 / 13
Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles \>16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.–0 / 111 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 35 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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