InfertilityPhase 4NCT00646893
Preimplantation Genetic Diagnosis for the Indication of Advanced Reproductive Age
A Phase 4 study testing Preimplantation Genetic Diagnosis (PGD) in people with Infertility, run by Reprogenetics at 5 sites in 2 countries.
Trial summary
The objective of this study is to demonstrate that Preimplantation Genetic diagnosis will significantly reduce spontaneous abortions and increase ongoing pregnancy rates in patients of advanced maternal age (37-42) undergoing IVF. Read more about this study
- Who is it for?
- Ages 37 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Preimplantation Genetic Diagnosis (PGD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jun 2008to Apr 2011
- Phase
- Phase 4
- 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 37 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal infertile women wishing to conceive
- Aged 37 42 years, inclusive,
- Regular menstrual cycles (generally 25 35 days in length) and screening early follicular phase FSH within normal limits.
Who cannot join
- Clinically significant systemic disease;
- Any contraindication to pregnancy or carrying pregnancy to term;
- Known ASRM Grade III or IV endometriosis;
- Clinically significant abnormal findings on a transvaginal ultrasound within 6 weeks prior to the beginning of OCP treatment;
- Extrauterine pregnancy within 3 months prior to the beginning of OCP treatment;
- ≥ 3 prior, initiated, consecutive ART cycles without a clinical pregnancy;
Show all 11Show fewer
- Prior severe OHSS;
- TESA and TESE patients;
- Patients carriers of chromosomal or genetic diseases.
- Egg donation cycles.
- Frozen Cycles.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
ART Reproductive Center,
Beverly Hills, California, 90210
Fertility Centers of Illinois
Highland Park, Illinois, 60035
Institute for Reproductive Medicine and Science at Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Reprogenetics
Livingston, New Jersey, 07039
About this study
Official title: Comparison of Embryo Transfer With and Without PGS for the Indication of Advanced Reproductive Age (37-42) in Patients Undergoing ART
The objective of this study is to demonstrate that Preimplantation Genetic diagnosis will significantly reduce spontaneous abortions and increase ongoing pregnancy rates in patients of advanced maternal age (37-42) undergoing IVF. We would like to test this hypothesis by a randomized trial performed with the most suitable conditions using very successful IVF laboratories capable to perform the embryo biopsy under strict controlled conditions after proper training and validation of the techniques.
Read the detailed description
Indications: Patients of advanced reproductive age wishing to receive preimplantation genetic screening in ART.
Objectives: To demonstrate that Preimplantation Genetic diagnosis (PGD) will significantly reduce spontaneous abortions and increase ongoing pregnancy rates in patients of advanced maternal age (37-42) undergoing IVF.
Test Method: Preimplantation Genetic Screening through FISH Treatment: In Vitro Fertilization treatment. The resulting embryos of the test group will undergo embryo biopsy followed by PGD with FISH using a 10-probe test with "no result rescue".
Study Population: 978 infertile women undergoing ART Major Inclusions: Premenopausal infertile women wishing to conceive, aged 37 42 years, inclusive, regular menstrual cycles and screening early follicular phase FSH within normal limits.
Major Exclusions: Clinically significant systemic disease; any contraindication to pregnancy or carrying pregnancy to term; known ASRM Grade III or IV endometriosis; clinically significant abnormal findings on a transvaginal ultrasound within 6 weeks prior to the beginning of OCP treatment; extrauterine pregnancy within 3 months prior to the beginning of OCP treatment; poor response in a previous ART cycle (≤ 3 oocytes retrieved); ≥ 3 prior, initiated, consecutive ART cycles without a clinical pregnancy; prior severe OHSS; TESA and TESE patients; patients carriers of chromosomal or genetic diseases.
Randomization: Eligible patients will be randomized in a 1:1 ratio to either:
Group A: Hatching "or" Group B: Hatching + PGS Study Procedures The study will be conducted on an outpatient basis. All pre-study screening assessments will be performed prior to treatment start.
Post-treatment Oocyte retrieval and embryology procedures will be Procedures performed according to the usual practice of the study center. Test Method Hatching, embryo biopsy, fixation and Fluorescence in-situ Hybridization (FISH) will be performed strictly in line with the methodology included in this protocol and only carried out by technicians certified by Reprogenetics.
Primary Endpoint: ongoing pregnancy rate (past 2nd trimester). Secondary Endpoints: implantation rate, pregnancy rate, miscarriage rate and live birth.
- Conditions
- Infertility
- Being tested
- Preimplantation Genetic Diagnosis (PGD)
- Keywords
- aneuploidy, miscarriage, pregnancy loss, PGD, PGS, Preimplantation Genetic Diagnosis, chromosome abnormalities, IVF, ART
- Medical subject headings
- Infertility, Aneuploidy, Abortion, Spontaneous, Chromosome Aberrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preimplantation Genetic Diagnosis (PGD)Procedure or surgery
Also called PGS, Preimplantation Genetic Screening
one-cell embryo biopsy on day 3 of development. The cell will be analyzed by FISH using probes for X,Y,13,15,16,17,18,21,22 chromosomes. Cells with dubious results will be reanalyzed by "no result rescue" (Colls et al. 2007)
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Control: assisted hatching, without Preimplantation Genetic Diagnosis |
| 2 | Experimental | Test: embryo biopsy with Preimplantation Genetic Diagnosis Receives: Procedure: Preimplantation Genetic Diagnosis (PGD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ongoing pregnancy rate (past 2nd trimester).
Measured: after 21 days, 20 weeks, and 7 month of treatment
Secondary outcomes (3)
spontaneous abortions
Measured: within 1st and 2nd trimester
pregnancy
Measured: one month for presence of fetal sac
implantation
Measured: first month, for presence of fetal sacs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2011 (estimated)
- Study completionApr 2011 (estimated)
Why it stopped: lack of appropriate funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reprogenetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Santiago Munne, PhD, Principal investigator, Reprogenetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646893
- Sponsor's protocol ID
- Reprogenetics-01
- Status last verified
- Feb 2010
- First submitted
- 26 Mar 2008
- Last updated
- 23 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Colls P, Escudero T, Cekleniak N, Sadowy S, Cohen J, Munne S. Increased efficiency of preimplantation genetic diagnosis for infertility using "no result rescue". Fertil Steril. 2007 Jul;88(1):53-61. doi: 10.1016/j.fertnstert.2006.11.099. Epub 2007 Feb 12.
PubMed 17296179
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Embryo Transfer With and Without PGS for the Indication of Advanced Reproductive Age (37-42) in Patients Undergoing ART
- ClinicalTrials.gov ID
- NCT00646893
- Acronym / sponsor ID
- Reprogenetics-01
- Conditions
- Infertility
- Keywords
- aneuploidy, miscarriage, pregnancy loss, PGD, PGS, Preimplantation Genetic Diagnosis, chromosome abnormalities, IVF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: lack of appropriate funding
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- ReprogeneticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 31 Mar 2008 (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.
The objective of this study is to demonstrate that Preimplantation Genetic diagnosis will significantly reduce spontaneous abortions and increase ongoing pregnancy rates in patients of advanced maternal age (37-42) undergoing IVF. We would like to test this hypothesis by a randomized trial performed with the most suitable conditions using very successful IVF laboratories capable to perform the embryo biopsy under strict controlled conditions after proper training and validation of the techniques.
Detailed description
Indications: Patients of advanced reproductive age wishing to receive preimplantation genetic screening in ART.
Objectives: To demonstrate that Preimplantation Genetic diagnosis (PGD) will significantly reduce spontaneous abortions and increase ongoing pregnancy rates in patients of advanced maternal age (37-42) undergoing IVF.
Test Method: Preimplantation Genetic Screening through FISH Treatment: In Vitro Fertilization treatment. The resulting embryos of the test group will undergo embryo biopsy followed by PGD with FISH using a 10-probe test with "no result rescue".
Study Population: 978 infertile women undergoing ART Major Inclusions: Premenopausal infertile women wishing to conceive, aged 37 42 years, inclusive, regular menstrual cycles and screening early follicular phase FSH within normal limits.
Major Exclusions: Clinically significant systemic disease; any contraindication to pregnancy or carrying pregnancy to term; known ASRM Grade III or IV endometriosis; clinically significant abnormal findings on a transvaginal ultrasound within 6 weeks prior to the beginning of OCP treatment; extrauterine pregnancy within 3 months prior to the beginning of OCP treatment; poor response in a previous ART cycle (≤ 3 oocytes retrieved); ≥ 3 prior, initiated, consecutive ART cycles without a clinical pregnancy; prior severe OHSS; TESA and TESE patients; patients carriers of chromosomal or genetic diseases.
Randomization: Eligible patients will be randomized in a 1:1 ratio to either:
Group A: Hatching "or" Group B: Hatching + PGS Study Procedures The study will be conducted on an outpatient basis. All pre-study screening assessments will be performed prior to treatment start.
Post-treatment Oocyte retrieval and embryology procedures will be Procedures performed according to the usual practice of the study center. Test Method Hatching, embryo biopsy, fixation and Fluorescence in-situ Hybridization (FISH) will be performed strictly in line with the methodology included in this protocol and only carried out by technicians certified by Reprogenetics.
Primary Endpoint: ongoing pregnancy rate (past 2nd trimester). Secondary Endpoints: implantation rate, pregnancy rate, miscarriage rate and live birth.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Control: assisted hatching, without Preimplantation Genetic Diagnosis |
| 2 | Experimental | Procedure: Preimplantation Genetic Diagnosis (PGD)Test: embryo biopsy with Preimplantation Genetic Diagnosis |
Who may qualify
- Ages
- 37 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Premenopausal infertile women wishing to conceive
- Aged 37 42 years, inclusive,
- Regular menstrual cycles (generally 25 35 days in length) and screening early follicular phase FSH within normal limits.
Key exclusion criteria (11 listed)
- Clinically significant systemic disease;
- Any contraindication to pregnancy or carrying pregnancy to term;
- Known ASRM Grade III or IV endometriosis;
- Clinically significant abnormal findings on a transvaginal ultrasound within 6 weeks prior to the beginning of OCP treatment;
- Extrauterine pregnancy within 3 months prior to the beginning of OCP treatment;
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 |
|---|---|---|
| Preimplantation Genetic Diagnosis (PGD)Also: PGS, Preimplantation Genetic Screeningone-cell embryo biopsy on day 3 of development. The cell will be analyzed by FISH using probes for X,Y,13,15,16,17,18,21,22 chromosomes. Cells with dubious results will be reanalyzed by "no result rescue" (Colls et al. 2007) | Procedure or surgery | 2 |
Primary outcome
ongoing pregnancy rate (past 2nd trimester).
Time frame: after 21 days, 20 weeks, and 7 month of treatment
3 secondary outcomes
spontaneous abortions
Time frame: within 1st and 2nd trimester
pregnancy
Time frame: one month for presence of fetal sac
implantation
Time frame: first month, for presence of fetal sacs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2010.
- Background: PubMed 17296179Colls P, Escudero T, Cekleniak N, Sadowy S, Cohen J, Munne S. Increased efficiency of preimplantation genetic diagnosis for infertility using "no result rescue". Fertil Steril. 2007 Jul;88(1):53-61. doi: 10.1016/j.fertnstert.2006.11.099. Epub 2007 Feb 12.
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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.
Santiago Munne, PhD principal investigator
Reprogenetics
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Preimplantation Genetic Diagnosis (PGD) in people with Infertility, run by Reprogenetics at 5 sites in 2 countries.
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 3 inclusion and 11 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: paused, as of the sponsor's last update on 23 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ongoing pregnancy rate (past 2nd trimester). (time frame: after 21 days, 20 weeks, and 7 month of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00646893, which also lists 1 linked publication.
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 23 Feb 2010.