Infertility, FemaleNCT05837325
Is the AMH Intrafollicular Level a Predictor of the Ploidy Status of the Blastocyst?
An observational study of Infertility, Female and Infertility, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial summary
To investigate, whether on the day of egg retrieval, after ovarian stimulation for ICSI (intracytoplasmic sperm injection), there is a correlation between the intrafollicular AMH (Anti-Müllerian hormone) levels and the ploidy status of the blastocyst. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, Infertility
- What is being tested?
- Oocyte Pick Up - Out of Study, Denudation - Out of Study and ICSI
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 23 May 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female undergoing IVF treatment
Who may be able to join
- At least one follicle from each ovary at day of trigger
- Age from 18 to 40 years old
- Normal menstrual cycle of 25-35 days
- Poor, normal and high response will be included
- First follicle punctured from each ovary will be consider for inclusion: if the COC (Cumulus Oocyte Complex) is present in clear FF (Follicular fluid), the FF will be collected separately for further analysis and the oocyte included in the study
Who cannot join
- Very hematic follicular fluid
- If the COC is not found in the follicular fluid
- Azoospermia
- Known chromosomal abnormalities
- Severe OAT (Oligoasthenoteratozoospermia)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site, 1 recruiting
- Recruiting
ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, 60202
Barbara Lawrenz, PhD, 0097126528000 ext. 1108, barbara.lawrenz@artfertilityclinics.com
Jonalyn Edades, 0097126528000 ext. 1106, jonalyn.edades@artfertilityclinics.com
About this study
Official title: Is the AMH Intrafollicular Level a Predictor of the Ploidy Status of the Blastocyst? A Prospective Study
To investigate, whether on the day of egg retrieval, after ovarian stimulation for ICSI (intracytoplasmic sperm injection), there is a correlation between the intrafollicular AMH (Anti-Müllerian hormone) levels and the ploidy status of the blastocyst.
Read the detailed description
In clinical practice, AMH is used as a diagnostic and/or prognostic marker in women in association with ovulation induction and in various pathophysiological conditions. This study looks to investigate if the hormonal environment that surrounds an oocyte has an impact on the ploidy status of the blastocyst. Nowadays, using NGS (Next Generation Sequencing) platform for analysis of 23 pairs of chromosomes for Preimplantation Genetic Testing on blastocysts, the ploidy status of the embryo is more adequately assessed. Furthermore, embryo culture to blastocyst will provide further information about embryo quality and possibilities of implantation.
To have complete information between the serum hormones, follicular hormones, embryo development and ploidy will provide to clinicians, embryologist and patients further information on embryo selection and adequate ovarian stimulation protocols.
The database will be exported from the clinical information manager, VRepro, to a table in excel format through a database-based query system. The exported data will be duly codified to protect the clinical and personal information of the participants. Prior to the statistical study, an exploratory data analysis will be carried out to review the quality of the information extracted.
- Conditions
- Infertility, Female, Infertility
- Being tested
- Oocyte Pick Up - Out of Study, Denudation - Out of Study, ICSI, Culture, Biopsy
- Keywords
- Estradiol, FSH, LH, AMH, Ploidy, Chromosomes, Infertility, Progesterone, Inhibin B
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte Pick Up - Out of StudyProcedure or surgery
Aspiration of follicles. search for the oocyte(s) All oocytes are grouped in one dish.
Denudation - Out of StudyProcedure or surgery
All oocytes are denuded together. Maturational stages are recorded.
ICSIProcedure or surgery
One oocyte injected at a time.
CultureProcedure or surgery
One embryo per culture drop. Individual follow-up of the embryo development.
BiopsyGenetic
One embryo per culture drop.
VitrificationProcedure or surgery
One embryo per vitrification straw.
OPU - Study GroupProcedure or surgery
Measure the size of the follicle and aspirate only one follicle and flush. The needle before moving to the second ovary. Oocyte included in the study will be cultured separately (each ovary separately too).
Denudation - Study GroupProcedure or surgery
Oocyte included in the study will be denuded separately. Maturational stages are recorded per follicle.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Not described Receives: Procedure: ICSI; Procedure: Culture; Genetic: Biopsy; Procedure: Vitrification; Procedure: OPU - Study Group; Procedure: Denudation - Study Group | |
| Out of Study Group | Not described Receives: Procedure: Oocyte Pick Up - Out of Study; Procedure: Denudation - Out of Study; Procedure: ICSI; Procedure: Culture; Genetic: Biopsy; Procedure: Vitrification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocyte maturity
Calculated as percentage transformation of an oocyte from prophase I to metaphase II
Measured: 1 day
Fertilization
Percentage of mature oocytes - metaphase II (MII) that become 2 pronucleii embryos (2PN)
Measured: 1 day
Blastulation
Ability of the embryo to form a cavity (=to blastulate) 114-118 hours post ICSI. Number of blastocysts divided by the number of 2PN
Measured: 1 day
Blastocyst quality
Four Embryo Quality Scores (EQ1, 2, 3, 4) based on the expansion stage of the blastocyst, the grade of the inner cell mass and the grade of the trophectoderm.
Measured: 6 days
Ploidy status
Determined after biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development
Measured: 14 days
Mitochondria status
Measured as mtDNA ratio, the ratio of mitochondrial DNA (mtDNA) read counts to autosomal (chromosome 1-22) DNA read counts
Measured: 14 days
Secondary outcomes (18)
AMH in the follicular fluid.
To evaluate if there is an association between the levels of serum AMH on day 2-3 of the stimulation, AMH day of OPU and the intra-follicular AMH.
Measured: 1 day
FSH in the follicular fluid.
To evaluate if there is an association between serum FSH on day 2-3 of the stimulation, serum FSH day of OPU and the intra-follicular FSH.
Measured: 1 day
LH in the follicular fluid.
To evaluate if there is an association between serum LH on day 2-3 of the stimulation, serum LH day of OPU and the intra-follicular LH.
Measured: 1 day
E2 in the follicular fluid.
To evaluate if there is an association between serum E2 on day 2-3 of the stimulation, serum E2 day of OPU and the intra-follicular E2.
Measured: 1 day
P4 in the follicular fluid.
To evaluate if there is an association between serum P4 on day 2-3 of the stimulation, serum P4 day of OPU and the intra-follicular P4.
Measured: 1 day
Inhibin B in the follicular fluid.
To evaluate if there is an association between serum Inhibin B on day 2-3 of the stimulation, serum Inhibin B day of OPU and the intra-follicular Inhibin B.
Measured: 1 day
AMH in serum day of OPU
To evaluate if there is an association between the levels of serum AMH on day 2-3 of the stimulation, AMH day of OPU and the intra-follicular AMH.
Measured: 1 day
FSH in serum day of OPU
To evaluate if there is an association between serum FSH on day 2-3 of the stimulation, serum FSH day of OPU and the intra-follicular FSH.
Measured: 1 day
LH in serum day of OPU
To evaluate if there is an association between serum LH on day 2-3 of the stimulation, serum LH day of OPU and the intra-follicular LH.
Measured: 1 day
E2 in serum day of OPU
To evaluate if there is an association between serum E2 on day 2-3 of the stimulation, serum E2 day of OPU and the intra-follicular E2.
Measured: 1 day
P4 in serum day of OPU
To evaluate if there is an association between serum P4 on day 2-3 of the stimulation, serum P4 day of OPU and the intra-follicular P4.
Measured: 1 day
Inhibin B in serum day of OPU
To evaluate if there is an association between serum Inhibin B on day 2-3 of the stimulation, serum Inhibin B day of OPU and the intra-follicular Inhibin B.
Measured: 1 day
AMH in serum day of day 2/3 of stimulation.
To evaluate if there is an association between the levels of serum AMH on day 2-3 of the stimulation, AMH day of OPU and the intra-follicular AMH.
Measured: 1 day
FSH in serum day of day 2/3 of stimulation.
To evaluate if there is an association between serum FSH on day 2-3 of the stimulation, serum FSH day of OPU and the intra-follicular FSH.
Measured: 1 day
LH in serum day of day 2/3 of stimulation.
To evaluate if there is an association between serum LH on day 2-3 of the stimulation, serum LH day of OPU and the intra-follicular LH.
Measured: 1 day
E2 in serum day of day 2/3 of stimulation.
To evaluate if there is an association between serum E2 on day 2-3 of the stimulation, serum E2 day of OPU and the intra-follicular E2.
Measured: 1 day
P4 in serum day of day 2/3 of stimulation.
To evaluate if there is an association between serum P4 on day 2-3 of the stimulation, serum P4 day of OPU and the intra-follicular P4.
Measured: 1 day
Inhibin B in serum day of day 2/3 of stimulation.
To evaluate if there is an association between serum Inhibin B on day 2-3 of the stimulation, serum Inhibin B day of OPU and the intra-follicular Inhibin B.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start23 May 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Melado, ART Fertility Clinics LLC
- Investigators
- Laura Melado, PhD, Principal investigator, ART Fertility Clinics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837325
- Sponsor's protocol ID
- 2212-ABU-015-LM
- Status last verified
- Jun 2025
- First submitted
- 13 Mar 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hattori Y, Sato T, Okada H, Saito C, Sugiura-Ogasawara M. Comparison of follicular fluid and serum anti-Mullerian hormone levels as predictors of the outcome of assisted reproductive treatment. Eur J Obstet Gynecol Reprod Biol. 2013 Jul;169(2):252-6. doi: 10.1016/j.ejogrb.2013.03.021. Epub 2013 Apr 25.
PubMed 23622971Capkin SI, Ozyer S, Karayalcin R, Moraloglu O, Ozcan S, Ugur M. Serum and follicular fluid Anti-Mullerian hormone concentrations at the time of follicle puncture and reproductive outcome. J Turk Ger Gynecol Assoc. 2012 Mar 1;13(1):21-6. doi: 10.5152/jtgga.2011.71. eCollection 2012.
PubMed 24627670Melado Vidales L, Fernandez-Nistal A, Martinez Fernandez V, Verdu Merino V, Bruna Catalan I, Bajo Arenas JM. Anti-Mullerian hormone levels to predict oocyte maturity and embryo quality during controlled ovarian hyperstimulation. Minerva Ginecol. 2017 Jun;69(3):225-232. doi: 10.23736/S0026-4784.16.03958-7. Epub 2016 Jun 28.
PubMed 27352270Hammoud I, Vialard F, Bergere M, Albert M, Gomes DM, Adler M, Malagrida L, Bailly M, Wainer R, Selva J. Follicular fluid protein content (FSH, LH, PG4, E2 and AMH) and polar body aneuploidy. J Assist Reprod Genet. 2012 Oct;29(10):1123-34. doi: 10.1007/s10815-012-9841-8. Epub 2012 Aug 14.
PubMed 22890422Calzada M, Lopez N, Noguera JA, Mendiola J, Hernandez AI, Corbalan S, Sanchez M, Torres AM. AMH in combination with SHBG for the diagnosis of polycystic ovary syndrome. J Obstet Gynaecol. 2019 Nov;39(8):1130-1136. doi: 10.1080/01443615.2019.1587604. Epub 2019 Jun 17.
PubMed 31208261Devroey P, Aboulghar M, Garcia-Velasco J, Griesinger G, Humaidan P, Kolibianakis E, Ledger W, Tomas C, Fauser BC. Improving the patient's experience of IVF/ICSI: a proposal for an ovarian stimulation protocol with GnRH antagonist co-treatment. Hum Reprod. 2009 Apr;24(4):764-74. doi: 10.1093/humrep/den468. Epub 2009 Jan 19.
PubMed 19153090Ferraretti AP, Gianaroli L. The Bologna criteria for the definition of poor ovarian responders: is there a need for revision? Hum Reprod. 2014 Sep;29(9):1842-5. doi: 10.1093/humrep/deu139. Epub 2014 Jul 9.
PubMed 25008235
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the AMH Intrafollicular Level a Predictor of the Ploidy Status of the Blastocyst? A Prospective Study
- ClinicalTrials.gov ID
- NCT05837325
- Acronym / sponsor ID
- 2212-ABU-015-LM
- Conditions
- Infertility, Female, Infertility
- Keywords
- Estradiol, FSH, LH, AMH, Ploidy, Chromosomes, Infertility, Progesterone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 May 2023 (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.
To investigate, whether on the day of egg retrieval, after ovarian stimulation for ICSI (intracytoplasmic sperm injection), there is a correlation between the intrafollicular AMH (Anti-Müllerian hormone) levels and the ploidy status of the blastocyst.
Detailed description
In clinical practice, AMH is used as a diagnostic and/or prognostic marker in women in association with ovulation induction and in various pathophysiological conditions. This study looks to investigate if the hormonal environment that surrounds an oocyte has an impact on the ploidy status of the blastocyst. Nowadays, using NGS (Next Generation Sequencing) platform for analysis of 23 pairs of chromosomes for Preimplantation Genetic Testing on blastocysts, the ploidy status of the embryo is more adequately assessed. Furthermore, embryo culture to blastocyst will provide further information about embryo quality and possibilities of implantation.
To have complete information between the serum hormones, follicular hormones, embryo development and ploidy will provide to clinicians, embryologist and patients further information on embryo selection and adequate ovarian stimulation protocols.
The database will be exported from the clinical information manager, VRepro, to a table in excel format through a database-based query system. The exported data will be duly codified to protect the clinical and personal information of the participants. Prior to the statistical study, an exploratory data analysis will be carried out to review the quality of the information extracted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Procedure: ICSI, Procedure: Culture, Genetic: Biopsy, Procedure: Vitrification, Procedure: OPU - Study Group, Procedure: Denudation - Study Group |
| Out of Study Group | – | Procedure: Oocyte Pick Up - Out of Study, Procedure: Denudation - Out of Study, Procedure: ICSI, Procedure: Culture, Genetic: Biopsy, Procedure: Vitrification |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female undergoing IVF treatment
Key inclusion criteria (5 listed)
- At least one follicle from each ovary at day of trigger
- Age from 18 to 40 years old
- Normal menstrual cycle of 25-35 days
- Poor, normal and high response will be included
- First follicle punctured from each ovary will be consider for inclusion: if the COC (Cumulus Oocyte Complex) is present in clear FF (Follicular fluid), the FF will be collected separately for further analysis and the oocyte included in the study
Key exclusion criteria (5 listed)
- Very hematic follicular fluid
- If the COC is not found in the follicular fluid
- Azoospermia
- Known chromosomal abnormalities
- Severe OAT (Oligoasthenoteratozoospermia)
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 |
|---|---|---|
| Oocyte Pick Up - Out of StudyAspiration of follicles. search for the oocyte(s) All oocytes are grouped in one dish. | Procedure or surgery | Out of Study Group |
| Denudation - Out of StudyAll oocytes are denuded together. Maturational stages are recorded. | Procedure or surgery | Out of Study Group |
| ICSIOne oocyte injected at a time. | Procedure or surgery | Out of Study Group, Study Group |
| CultureOne embryo per culture drop. Individual follow-up of the embryo development. | Procedure or surgery | Out of Study Group, Study Group |
| BiopsyOne embryo per culture drop. | Genetic | Out of Study Group, Study Group |
| VitrificationOne embryo per vitrification straw. | Procedure or surgery | Out of Study Group, Study Group |
| OPU - Study GroupMeasure the size of the follicle and aspirate only one follicle and flush. The needle before moving to the second ovary. Oocyte included in the study will be cultured separately (each ovary separately too). | Procedure or surgery | Study Group |
| Denudation - Study GroupOocyte included in the study will be denuded separately. Maturational stages are recorded per follicle. | Procedure or surgery | Study Group |
Primary outcome
Oocyte maturity
Time frame: 1 day
Calculated as percentage transformation of an oocyte from prophase I to metaphase II
Fertilization
Time frame: 1 day
Percentage of mature oocytes - metaphase II (MII) that become 2 pronucleii embryos (2PN)
Blastulation
Time frame: 1 day
Ability of the embryo to form a cavity (=to blastulate) 114-118 hours post ICSI. Number of blastocysts divided by the number of 2PN
Blastocyst quality
Time frame: 6 days
Four Embryo Quality Scores (EQ1, 2, 3, 4) based on the expansion stage of the blastocyst, the grade of the inner cell mass and the grade of the trophectoderm.
Ploidy status
Time frame: 14 days
Determined after biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development
Mitochondria status
Time frame: 14 days
Measured as mtDNA ratio, the ratio of mitochondrial DNA (mtDNA) read counts to autosomal (chromosome 1-22) DNA read counts
18 secondary outcomes
AMH in the follicular fluid.
Time frame: 1 day
FSH in the follicular fluid.
Time frame: 1 day
LH in the follicular fluid.
Time frame: 1 day
E2 in the follicular fluid.
Time frame: 1 day
P4 in the follicular fluid.
Time frame: 1 day
Inhibin B in the follicular fluid.
Time frame: 1 day
AMH in serum day of OPU
Time frame: 1 day
FSH in serum day of OPU
Time frame: 1 day
LH in serum day of OPU
Time frame: 1 day
E2 in serum day of OPU
Time frame: 1 day
P4 in serum day of OPU
Time frame: 1 day
Inhibin B in serum day of OPU
Time frame: 1 day
AMH in serum day of day 2/3 of stimulation.
Time frame: 1 day
FSH in serum day of day 2/3 of stimulation.
Time frame: 1 day
LH in serum day of day 2/3 of stimulation.
Time frame: 1 day
E2 in serum day of day 2/3 of stimulation.
Time frame: 1 day
P4 in serum day of day 2/3 of stimulation.
Time frame: 1 day
Inhibin B in serum day of day 2/3 of stimulation.
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Background: PubMed 23622971Hattori Y, Sato T, Okada H, Saito C, Sugiura-Ogasawara M. Comparison of follicular fluid and serum anti-Mullerian hormone levels as predictors of the outcome of assisted reproductive treatment. Eur J Obstet Gynecol Reprod Biol. 2013 Jul;169(2):252-6. doi: 10.1016/j.ejogrb.2013.03.021. Epub 2013 Apr 25.
- Background: PubMed 24627670Capkin SI, Ozyer S, Karayalcin R, Moraloglu O, Ozcan S, Ugur M. Serum and follicular fluid Anti-Mullerian hormone concentrations at the time of follicle puncture and reproductive outcome. J Turk Ger Gynecol Assoc. 2012 Mar 1;13(1):21-6. doi: 10.5152/jtgga.2011.71. eCollection 2012.
- Background: PubMed 27352270Melado Vidales L, Fernandez-Nistal A, Martinez Fernandez V, Verdu Merino V, Bruna Catalan I, Bajo Arenas JM. Anti-Mullerian hormone levels to predict oocyte maturity and embryo quality during controlled ovarian hyperstimulation. Minerva Ginecol. 2017 Jun;69(3):225-232. doi: 10.23736/S0026-4784.16.03958-7. Epub 2016 Jun 28.
- Background: PubMed 22890422Hammoud I, Vialard F, Bergere M, Albert M, Gomes DM, Adler M, Malagrida L, Bailly M, Wainer R, Selva J. Follicular fluid protein content (FSH, LH, PG4, E2 and AMH) and polar body aneuploidy. J Assist Reprod Genet. 2012 Oct;29(10):1123-34. doi: 10.1007/s10815-012-9841-8. Epub 2012 Aug 14.
- Background: PubMed 31208261Calzada M, Lopez N, Noguera JA, Mendiola J, Hernandez AI, Corbalan S, Sanchez M, Torres AM. AMH in combination with SHBG for the diagnosis of polycystic ovary syndrome. J Obstet Gynaecol. 2019 Nov;39(8):1130-1136. doi: 10.1080/01443615.2019.1587604. Epub 2019 Jun 17.
- Background: PubMed 19153090Devroey P, Aboulghar M, Garcia-Velasco J, Griesinger G, Humaidan P, Kolibianakis E, Ledger W, Tomas C, Fauser BC. Improving the patient's experience of IVF/ICSI: a proposal for an ovarian stimulation protocol with GnRH antagonist co-treatment. Hum Reprod. 2009 Apr;24(4):764-74. doi: 10.1093/humrep/den468. Epub 2009 Jan 19.
- Background: PubMed 25008235Ferraretti AP, Gianaroli L. The Bologna criteria for the definition of poor ovarian responders: is there a need for revision? Hum Reprod. 2014 Sep;29(9):1842-5. doi: 10.1093/humrep/deu139. Epub 2014 Jul 9.
- Individual participant dataSharing planned: Undecided
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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.
Laura Melado, PhD principal investigator
ART Fertility Clinics LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and Infertility, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
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 5 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: looking for participants now, as of the sponsor's last update on 2 Oct 2025. 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 United Arab Emirates. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Lawrenz, PhD (0097126528000 ext. 1108, barbara.lawrenz@artfertilityclinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oocyte maturity (time frame: 1 day). The study lists 6 primary outcomes in all. 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 NCT05837325, which also lists 7 linked publications.
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 2 Oct 2025.