InfertilityDevitNCT04758819
Efficiency of Comprehensive Chromosomal Testing of Trophectoderm Biopsies of Blastocysts in In Vitro Fertilization
A study testing Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts (CTTEB) in people with Infertility, run by Assistance Publique - Hôpitaux de Paris at 10 sites in France.
Trial summary
Preimplantation embryo aneuploidy is a major source of adverse outcomes in human reproduction since it leads to implantation failure, early pregnancy loss or severe chromosomal diseases. The risk of embryos aneuploidy is drastically increased after 35 years old. Read more about this study
- Who is it for?
- Ages 35 to 41 years
- Conditions the study is for
- Infertility
- What is being tested?
- Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts (CTTEB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 10 sitesFrance
- Study dates
- 12 Jul 2021to Jan 2026
- 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 35 to 41 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Women :
- Age ≥35 to ≤ 41 years old (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including intracytoplasmic sperm injection (ICSI)
- BMI=18-35 kg/m2 inclusive
- No intrauterine and/or endometrial abnormalities that would interfere with implantation or pregnancy (for instance polyp, fibroid, …)
- Use of ejaculated motile sperm (donated and/or cryopreserved sperm is allowed)
- Age ≤ 50 years old
Show all 12Show fewer
- Primary or secondary infertility
- Dated and signed inform consent
- Affiliated to National Insurance
- French speaking, able to understand the study
- Criteria after randomization
- Couple having at least one blastocyst with morphological score on Day 5/6 of in vitro embryo development (blastocoel expansion ≥3 and inner cell mass graded A, B or C and trophectoderm graded A or B
Who cannot join
- Women:
- Recurrent implantation failure (previous transfer of least 5 good grade blastocysts in at least 3 fresh or frozen cycles)
- Personal history of recurrent miscarriages (more than two miscarriages)
- Altered ovarian reserve: Identified risk of poor ovarian response (history of oocyte puncture with less than 3 oocytes) or AMH<1.1 ng/mL and AFC<5)
- Presence of non isolated uni- or bilateral hydrosalpinx
- History or presence of ovarian, uterine or mammary cancer
Show all 25Show fewer
- Contraindication to being pregnant and/or carrying a pregnancy to term
- Women with uterine polyps diagnosed during COS
- Known allergy or hypersensitivity to human gonadotropin preparations or to compounds that are structurally similar to any of the other medications administered during the trial
- Substance abuse that would interfere with trial conduct, as determined by the investigator
- Pregnant patient, nursing patient
- Men:
- Use of testicular or epididymal sperm
- Couples:
- Known infection with human immunodeficiency virus, active hepatitis B or C virus in the female or male partner
- Scheduled for an embryo transfer on day 2 or 3
- Embryo freezing refusal
- Scheduled for a fresh embryo transfer
- Scheduled with an egg donation
- Scheduled with autologous oocytes thawing
- Scheduled for a preimplantation genetic diagnosis
- Participation in another ART clinical trial within the past 30 days
- Participation with another interventional study involving human subjects
- Exlusion criteria to check on randomization day :
- Women with less than 3 follicles ≥ 14 mm on the triggering day or the day before the triggering
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
Hôpital Jean Verdier
Bondy, 93
Christophe SIFER, MD, PhD, +33 1 48 02 68 95, christophe.sifer@aphp.fr
- Recruiting
Hôpital Antoine Béclère
Clamart, 92140
Nelly Frydman, Pharm D, PhD, +33 1 45 37 49 79, nelly.frydman@aphp.fr
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Florence Brugnon, MD, PhD, +33 4 73 75 02 31, fbrugnon@chu-clermontferrand.fr
- Recruiting
CHU Dijon
Dijon, 21079
Patricia Fauque, Md, PhD, +33 3 80 29 50 31, patricia.fauque@chu-dijon.fr
- Recruiting
Hôpital Arnaud de Villeneuve
Montpellier, 34295
Samir Hamamah, PhD, +33 4 67 33 64 04, s-hamamah@chu-montpellier.fr
- Recruiting
CHU Nantes
Nantes, 44093
Thomas Freaour, MD, PhD, +33 2 40 08 32 34, thomas.freour@chu-nantes.fr
- Recruiting
Hôpital Cochin
Paris, 75014
Catherine Patrat, MD, PhD, +33 1 58 41 37 48, catherine.patrat@aphp.fr
- Not yet recruiting
Hopital Tenon
Paris, 75020
Rachel Levy, MD, PhD, +33 1 56 01 71 76, rachel.levy@aphp.fr
- Recruiting
CHU Strasbourg
Schiltigheim, 67300
Isabelle Lichtblau, MD, +33 3 69 55 35 20, Isabelle.lichtblau@chru-strasbourg.fr
- Recruiting
Hôpital Foch
Suresnes, 92
Marine POULAIN, MD, PhD, +33 1 46 25 35 21, marine.poulain@hopital-foch.com
About this study
Official title: Comprehensive Chromosomal Testing of Trophectoderm Biopsies of Blastocysts to Improve Live Birth Rates After in Vitro Fertilization: a Prospective Randomized Trial
Preimplantation embryo aneuploidy is a major source of adverse outcomes in human reproduction since it leads to implantation failure, early pregnancy loss or severe chromosomal diseases. The risk of embryos aneuploidy is drastically increased after 35 years old. The intra uterine transfer of euploid embryos assessed through such techniques as next-generation sequencing (NGS) based Comprehensive chromosomal Testing of Trophectoderm (TE) biopsies of Blastocysts (CTTEB), may improve implantation and live birth rates, and decrease miscarriage rates. But no randomized controlled trial (RCT) was ever performed to test the interest of CTTEB for women that really needed it (≥35 to ≤ 41 years old). In this multicentre randomized-controlled-trial, the investigators will compare live birth rate obtained after the first single frozen-thawed blastocyst transfer cycle following the freeze-all-Intracytoplasmic sperm injection cycle in infertile and old couples between two different strategies of Day 5/6 blastocyst selection:
- Control group: morphological criteria (Istanbul consensus)
- Interventional group: international recommendations after CTTEB (www.pgdis.org; Newsletter May 27, 2019).
Read the detailed description
The presence of chromosomal abnormalities (aneuploidy) in the pre-implantation embryonic stage is one of the major causes of human reproductive disorders, as it is responsible for embryo implantation failures, early or late miscarriages and the birth of children with chromosomal syndromes. This is mainly due to the existence of chromosomal abnormalities of meiotic, especially maternal, or mitotic origin occurring during the first three cell divisions of the embryo. As a result, human embryos have higher rates of aneuploidy than other species. Thus, it has been suggested that only 30% of conceptions reach term.
The objective of Assisted Reproductive Technologies (ART) is to optimize the chances of conception and delivery of healthy new-borns. It is necessary to improve the results of IVF (in vitro fertilization) programs and to reduce adverse effects (miscarriages, multiple pregnancies), especially in couples with patients with poor prognosis, such as older women. The choice of embryos to be transferred is a key step for the success of ART infertility treatments.
Currently, the choice of embryos is based solely on their morphology, evaluated on the 5th or 6th day of development at a stage known as the "blastocyst". Each embryo is observed under the microscope and described according to standardized morphological criteria. This description of the blastocyst is based on 3 constituents of the embryo: the degree of expansion of the blastocoelic cavity, the appearance of the internal cell mass (ICM) and the presence of trophectodermal cells (TE). These criteria have been described as predictive of live birth rates after transfer of fresh or thawed embryos. However, its ability to identify the embryo with the highest potential for implantation is debatable, due to its weak association with embryonic chromosomal status, which is a critical factor in the implant potential of each embryo. In addition, it is known that embryos that do not meet these morphological criteria are discarded, although it has been proven that their transfer could lead to a live birth.
Since the risk of embryonic aneuploidy is significantly increased after the age of 35, the objective of our RCT is to evaluate the efficacy of the CTTEB using the latest technologies and methodologies (i.e., combined embryo culture to blastocyst stage, immediate freezing of the embryonic cohort with delayed transfer, TE biopsy, NGS, and Single Embryo Transfer (SET)) in the management of infertile patients over 35 years of age. The live birth rate obtained after the first transfer of a single frozen embryo will be compared between two groups of couples, randomized in two arms: i) transfer of a single euploid blastocyst; ii) transfer of a single blastocyst of unknown chromosomal status, chosen on the basis of the usual morphological criteria, in the first thawing cycle following the freezing of all the blastocysts of the patient couples.
In addition, the culture medium of each embryo collected will be analysed in a second stage to assess whether it is possible to develop a diagnosis of aneuploidy without the need for trophectoderm biopsy (non invasive).
- Conditions
- Infertility
- Being tested
- Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts (CTTEB)
- Keywords
- embryo aneuploidy, Intracytoplasmic Sperm Injection, in vitro fertilization, Next-Generation Sequencing, randomized controlled trial
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts (CTTEB)Procedure or surgery
In vitro Fertilization by ICSI then embryo culture until Day 5/6; all blastocysts with morphological scores compatible with TE biopsy and vitrification will be submitted to Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts (CTTEB) and vitrified.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Embryo selection according to Day 5/6 usual morphological criteria (Istanbul consensus) |
| Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts: CTTEB group | Experimental | Trophectoderm cells will be analyzed by NGS. Culture media will also be stored for further non-invasive chromosomal testing. Embryo selection will be done according to international guidelines (www.pgdis.org; Newsletter May 27, 2019). Receives: Procedure: Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts (CTTEB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of live birth
To compare live birth rate (LBR) obtained after the first single frozen-thawed blastocyst transfer cycle following the freeze-all-Intracytoplasmic sperm injection (ICSI) cycle
Measured: One year
Secondary outcomes (13)
Number of live birth taking in consideration further single frozen-thawed blastocyst cycles
To compare live birth rate between both groups from the time where couples are randomized, i.e. in intention to treat principle, taking in consideration further single frozen-thawed blastocyst cycles during the studied period ("cumulative live birth" rate limited to the studied period)
Measured: Until 48 months
Biological ICSI parameters
Biological ICSI parameters will be assessed using a composite variable defined by:
- Number of oocyte retrievals without blastocyst and/or blastocysts vitrification
- Number of cryopreserved Day 5 and/or Day 6 blastocysts
- Number of blastocysts still cryopreserved at the end of the study
Measured: 30 months (inclusion period)
Pregnancy outcome
Pregnancy parameters will be assessed using a composite variable defined by:
- Implantation rate (ratio between gestational sacs and transferred embryo)
- Rate of started (hCG>100UI/ml) per oocyte retrieval
- Rate of started (hCG>100UI/ml) per embryo transfer
- Rate of clinical pregnancy (defined by at least one gestational sac at ultrasound) per oocyte retrieval
- Rate of clinical pregnancy (defined by at least one gestational sac at ultrasound) per embryo transfer
- Rate of ongoing (≥ 12 WA) pregnancy per oocyte retrieval
- Rate of ongoing (≥ 12 WA) pregnancy per embryo transfer
Measured: 18 months (participation period)
Ratio between the proportion of women with live birth and days after randomization
- Ratio between the proportion of women with live birth and days after randomization
Measured: Until 48 months
Cost of the procedure
To compare cost of the procedure between both groups and estimate a cost per additional live birth
Measured: 18 months (participation period)
Efficiency of non-invasive chromosomal testing
Direct cost of non-invasive chromosomal testing, in blastocyst culture conditioned medium, as compared to the referent standard one, after TE biopsies and total cost .
Measured: Until 48 months
obstetrical parameters
obstetrical parameters will be assessed using a composite variable defined by:
- Miscarriage, defined as a clinical pregnancy loss that occurs before 20 WA;
- Pre-eclampsia, defined as gestational hypertension (Blood pressure ≥ 14 mm Hg systolic or ≥ 9 mm Hg diastolic,associated with proteinuria ≥ 0.3 grams (300 mg) or more of protein in a 24-hour urine sample
Measured: 18 months (participation period)
Perinatal parameters:
Perinatal parameters defined by:
- gestational age (in WA)
Measured: 18 months (participation period)
Perinatal parameters:
Perinatal parameters defined by:
- biometry (weight (g))
Measured: 18 months (participation period)
Perinatal parameters:
Perinatal parameters defined by:
- height (cm)
- head circumference (cm) according to the sex of newborns
Measured: 18 months (participation period)
Perinatal parameters:
Perinatal parameters defined by:
- Apgar score at 1 and 5mn after birth (/10)
Measured: 18 months (participation period)
Perinatal parameters:
Perinatal parameters defined by:
- Number or children admitted in admission to neonatal intensive care unit
Measured: 18 months (participation period)
Perinatal parameters:
Perinatal parameters defined by:
- Number of children with major malformations defined according to the European register EUROCAT)
Measured: 18 months (participation period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start12 Jul 2021
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelly Frydman, Pharm D, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758819
- Sponsor's protocol ID
- APHP 200006
- Acronym
- Devit
- Status last verified
- Jan 2024
- First submitted
- 30 Nov 2020
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Chromosomal Testing of Trophectoderm Biopsies of Blastocysts to Improve Live Birth Rates After in Vitro Fertilization: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04758819
- Acronym / sponsor ID
- Devit / APHP 200006
- Conditions
- Infertility
- Keywords
- embryo aneuploidy, Intracytoplasmic Sperm Injection, in vitro fertilization, Next-Generation Sequencing, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 17 Feb 2021 (actual)
- 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.
Preimplantation embryo aneuploidy is a major source of adverse outcomes in human reproduction since it leads to implantation failure, early pregnancy loss or severe chromosomal diseases. The risk of embryos aneuploidy is drastically increased after 35 years old. The intra uterine transfer of euploid embryos assessed through such techniques as next-generation sequencing (NGS) based Comprehensive chromosomal Testing of Trophectoderm (TE) biopsies of Blastocysts (CTTEB), may improve implantation and live birth rates, and decrease miscarriage rates. But no randomized controlled trial (RCT) was ever performed to test the interest of CTTEB for women that really needed it (≥35 to ≤ 41 years old). In this multicentre randomized-controlled-trial, the investigators will compare live birth rate obtained after the first single frozen-thawed blastocyst transfer cycle following the freeze-all-Intracytoplasmic sperm injection cycle in infertile and old couples between two different strategies of Day 5/6 blastocyst selection:
- Control group: morphological criteria (Istanbul consensus)
- Interventional group: international recommendations after CTTEB (www.pgdis.org; Newsletter May 27, 2019).
Detailed description
The presence of chromosomal abnormalities (aneuploidy) in the pre-implantation embryonic stage is one of the major causes of human reproductive disorders, as it is responsible for embryo implantation failures, early or late miscarriages and the birth of children with chromosomal syndromes. This is mainly due to the existence of chromosomal abnormalities of meiotic, especially maternal, or mitotic origin occurring during the first three cell divisions of the embryo. As a result, human embryos have higher rates of aneuploidy than other species. Thus, it has been suggested that only 30% of conceptions reach term.
The objective of Assisted Reproductive Technologies (ART) is to optimize the chances of conception and delivery of healthy new-borns. It is necessary to improve the results of IVF (in vitro fertilization) programs and to reduce adverse effects (miscarriages, multiple pregnancies), especially in couples with patients with poor prognosis, such as older women. The choice of embryos to be transferred is a key step for the success of ART infertility treatments.
Currently, the choice of embryos is based solely on their morphology, evaluated on the 5th or 6th day of development at a stage known as the "blastocyst". Each embryo is observed under the microscope and described according to standardized morphological criteria. This description of the blastocyst is based on 3 constituents of the embryo: the degree of expansion of the blastocoelic cavity, the appearance of the internal cell mass (ICM) and the presence of trophectodermal cells (TE). These criteria have been described as predictive of live birth rates after transfer of fresh or thawed embryos. However, its ability to identify the embryo with the highest potential for implantation is debatable, due to its weak association with embryonic chromosomal status, which is a critical factor in the implant potential of each embryo. In addition, it is known that embryos that do not meet these morphological criteria are discarded, although it has been proven that their transfer could lead to a live birth.
Since the risk of embryonic aneuploidy is significantly increased after the age of 35, the objective of our RCT is to evaluate the efficacy of the CTTEB using the latest technologies and methodologies (i.e., combined embryo culture to blastocyst stage, immediate freezing of the embryonic cohort with delayed transfer, TE biopsy, NGS, and Single Embryo Transfer (SET)) in the management of infertile patients over 35 years of age. The live birth rate obtained after the first transfer of a single frozen embryo will be compared between two groups of couples, randomized in two arms: i) transfer of a single euploid blastocyst; ii) transfer of a single blastocyst of unknown chromosomal status, chosen on the basis of the usual morphological criteria, in the first thawing cycle following the freezing of all the blastocysts of the patient couples.
In addition, the culture medium of each embryo collected will be analysed in a second stage to assess whether it is possible to develop a diagnosis of aneuploidy without the need for trophectoderm biopsy (non invasive).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Embryo selection according to Day 5/6 usual morphological criteria (Istanbul consensus) |
| Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts: CTTEB group | Experimental | Procedure: Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts (CTTEB)Trophectoderm cells will be analyzed by NGS. Culture media will also be stored for further non-invasive chromosomal testing. Embryo selection will be done according to international guidelines (www.pgdis.org; Newsletter May 27, 2019). |
Who may qualify
- Ages
- 35 to 41 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age ≥35 to ≤ 41 years old (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including intracytoplasmic sperm injection (ICSI)
- BMI=18-35 kg/m2 inclusive
- No intrauterine and/or endometrial abnormalities that would interfere with implantation or pregnancy (for instance polyp, fibroid, …)
- Use of ejaculated motile sperm (donated and/or cryopreserved sperm is allowed)
- Age ≤ 50 years old
Key exclusion criteria (25 listed)
- Recurrent implantation failure (previous transfer of least 5 good grade blastocysts in at least 3 fresh or frozen cycles)
- Personal history of recurrent miscarriages (more than two miscarriages)
- Altered ovarian reserve: Identified risk of poor ovarian response (history of oocyte puncture with less than 3 oocytes) or AMH<1.1 ng/mL and AFC<5)
- Presence of non isolated uni- or bilateral hydrosalpinx
- History or presence of ovarian, uterine or mammary cancer
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 |
|---|---|---|
| Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts (CTTEB)In vitro Fertilization by ICSI then embryo culture until Day 5/6; all blastocysts with morphological scores compatible with TE biopsy and vitrification will be submitted to Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts (CTTEB) and vitrified. | Procedure or surgery | Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts: CTTEB group |
Primary outcome
Number of live birth
Time frame: One year
To compare live birth rate (LBR) obtained after the first single frozen-thawed blastocyst transfer cycle following the freeze-all-Intracytoplasmic sperm injection (ICSI) cycle
13 secondary outcomes
Number of live birth taking in consideration further single frozen-thawed blastocyst cycles
Time frame: Until 48 months
Biological ICSI parameters
Time frame: 30 months (inclusion period)
Pregnancy outcome
Time frame: 18 months (participation period)
Ratio between the proportion of women with live birth and days after randomization
Time frame: Until 48 months
Cost of the procedure
Time frame: 18 months (participation period)
Efficiency of non-invasive chromosomal testing
Time frame: Until 48 months
obstetrical parameters
Time frame: 18 months (participation period)
Perinatal parameters:
Time frame: 18 months (participation period)
Perinatal parameters:
Time frame: 18 months (participation period)
Perinatal parameters:
Time frame: 18 months (participation period)
Perinatal parameters:
Time frame: 18 months (participation period)
Perinatal parameters:
Time frame: 18 months (participation period)
Perinatal parameters:
Time frame: 18 months (participation period)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Nelly Frydman, Pharm D, PhD study director
Assistance Publique - Hôpitaux de Paris
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts (CTTEB) in people with Infertility, run by Assistance Publique - Hôpitaux de Paris at 10 sites in France.
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 12 inclusion and 25 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 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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.
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 Catherine Patrat, MD, PhD (+33 1 58 41 37 34, catherine.patrat@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of live birth (time frame: One year). 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 19 Jan 2024.