Pregnancy RelatedPhase 1NCT05969795
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
A Phase 1 study testing Transvaginal ultrasound, Serial serum LH, E2, P4 and Progesterone 100 Mg Vaginal Insert in people with Pregnancy Related and Infertility, Female, run by ART Fertility Clinics LLC at 3 sites in United Arab Emirates.
Trial summary
To evaluate whether single euploid embryo transfer in NC without routinely administered LPS is non-inferior to NC with routinely administered LPS. 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
- Pregnancy Related, Infertility, Female
- What is being tested?
- Transvaginal ultrasound, Serial serum LH, E2, P4 and Progesterone 100 Mg Vaginal Insert
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 3 sitesUnited Arab Emirates
- Study dates
- 5 Sep 2023to 30 Sep 2026
- Phase
- Phase 1
- 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
Who may be able to join
- Age: 18 to 40 years
- Regular ovulatory cycles
- Availability of at least one euploid embryo after Trophectoderm biopsy for PGT-A on day 5 or day 6
- Detection of ovulation by P4 rise > 1.0 ng/ml after LH surge
- P4 value of at least 5 ng/ml on day 4 after ovulation
Who cannot join
- History of repeated pre-menstrual spotting
- Factors affecting the implantation through anatomical changes of the uterus / ovaries or the tubes (adenomyosis, Asherman syndrome, endometriosis, uterine fibroids / polyps, isthmocele with intracavitary fluid presence, hydrosalpinx….)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates3 sites, 3 recruiting
- Recruiting
ART Fertility Clinics LLC
Abu Dhabi, 60202
Barbara Lawrenz, PhD, +971 800 337845489, barbara.lawrenz@artfertilityclinics.com
- Recruiting
ART Fertility Clinics Al Ain
Al Ain City
Anastasia Salame, +971 800 337845489, jonalyn.edades@artfertilityclinics.com
- Not yet recruiting
ART Fertility Clinics Dubai
Dubai
Carol Coughlan, PhD, +971 800 337845489, jonalyn.edades@artfertilityclinics.com
About this study
Official title: Comparison of Live Birth Rate (> 24 Weeks) in Natural Cycle (NC) Single Euploid Frozen Embryo Transfers (FET) With Versus Without Luteal Phase Support (LPS)
To evaluate whether single euploid embryo transfer in NC without routinely administered LPS is non-inferior to NC with routinely administered LPS.
Read the detailed description
In case the study will show that the live birth rate in single euploid NC frozen embryo transfer cycles without LPS is not inferior to NC cycles with LPS, treatment can be simplified, and participants comfort can be increased.
- Conditions
- Pregnancy Related, Infertility, Female
- Being tested
- Transvaginal ultrasound, Serial serum LH, E2, P4, Progesterone 100 Mg Vaginal Insert, Serum P4 day of ET - Control Group, Serum P4 day of ET - Study Group
- Keywords
- implantation rate, infertility, pregnancy rate, natural cycle, luteal phase support, live birth, progesterone
- 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.
Transvaginal ultrasoundDiagnostic test
Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth
Serial serum LH, E2, P4Diagnostic test
Serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4 )levels throughout the cycle to determine ovulation. LH-surge is identified when a rise of 180% above the previous level occurred and ovulation is confirmed with a decrease in E2 concentration, and a rise of progesterone level to ≥ 1.0 ng/ml (Irani et al., 2017).
Progesterone 100 Mg Vaginal InsertDrug
Also called Progesterone 100Mg Vag Tab
On day of ET procedure, to administer 200 mg of vaginal progesterone and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy
Serum P4 day of ET - Control GroupDiagnostic test
Serum P4 will be drawn before starting LPS in form of vaginal progesterone on the day of ET procedure
Serum P4 day of ET - Study GroupDiagnostic test
Serum P4 will be drawn when study group participants are admitted to the clinic for the ET procedure.
Embryo transferProcedure or surgery
Also called ET
The procedure in which embryo is placed in the uterus.
Serum hCG 10 days after ETDiagnostic test
Pregnancy will be confirmed / excluded by measurement of serum hCG 10 days after ET procedure and a level of > 15 IU will be regarded as positive result. The definitions of biochemical, ectopic, clinical and ongoing pregnancy follow the ICMART criteria (Zegers-Hochschild, 2006)
Serum P4 10 days after ETDiagnostic test
Serum P4 will be drawn on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Other | Intermittent ultrasound scans to monitor follicular growth and serial measurements of serum LH, E2 and P4 levels throughout the cycle to determine ovulation. Embryo transfer (ET) will be scheduled on the fifth day after ovulation. Blood for P4 measurement will be drawn upon admission to the clinic for the ET procedure. P4 will be measured on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure. Receives: Diagnostic Test: Transvaginal ultrasound; Diagnostic Test: Serial serum LH, E2, P4; Diagnostic Test: Serum P4 day of ET - Study Group; Procedure: Embryo transfer; Diagnostic Test: Serum hCG 10 days after ET; Diagnostic Test: Serum P4 10 days after ET |
| Control Group | Other | Intermittent ultrasound scans to monitor follicular growth and serial measurements of serum LH, E2 and P4 levels throughout the cycle to determine ovulation. Embryo transfer (ET) will be scheduled on the fifth day after ovulation. Administer on FET day 200 mg of P4 and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. Blood for P4 measurement will be drawn before starting LPS in form of vaginal progesterone. P4 will be measured on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy. Receives: Diagnostic Test: Transvaginal ultrasound; Diagnostic Test: Serial serum LH, E2, P4; Drug: Progesterone 100 Mg Vaginal Insert; Diagnostic Test: Serum P4 day of ET - Control Group; Procedure: Embryo transfer; Diagnostic Test: Serum hCG 10 days after ET; Diagnostic Test: Serum P4 10 days after ET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
Number of embryos which have produced ultrasonographic evidence of an intrauterine gestational sac per the total number of embryos transferred into the uterine cavity (Zegers-Hochschild et al., 2009).
Measured: 2 months
Clinical pregnancy rate
hCG > 15 Iu/ml and ultrasound confirmation of a gestational sac
Measured: 2 months
Live birth rate
Number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers (Zegers-Hochschild et al., 2009)
Measured: 41 weeks
Serum P4 levels on ET day
Progesterone level on the day of embryo transfer
Measured: 1 day
Serum E2 and P4 levels on day 5 or 6 after ET procedure
Estradiol and Progesterone levels on day 5 or 6 after embryo transfer
Measured: 6 days
Serum E2 and P4 levels on day 10 after ET procedure
Estradiol and Progesterone levels on day 10 after embryo transfer
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start5 Sep 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Lawrenz, ART Fertility Clinics LLC
- Investigators
- Barbara Lawrenz, PhD, Principal investigator, ART Fertility Clinics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969795
- Sponsor's protocol ID
- 2306-ABU-009-BL
- Status last verified
- Jan 2025
- First submitted
- 24 Jul 2023
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bortoletto P, Prabhu M, Baker VL. Association between programmed frozen embryo transfer and hypertensive disorders of pregnancy. Fertil Steril. 2022 Nov;118(5):839-848. doi: 10.1016/j.fertnstert.2022.07.025. Epub 2022 Sep 25.
PubMed 36171152Csapo AI, Pulkkinen M. Indispensability of the human corpus luteum in the maintenance of early pregnancy. Luteectomy evidence. Obstet Gynecol Surv. 1978 Feb;33(2):69-81. doi: 10.1097/00006254-197802000-00001. No abstract available.
PubMed 341008Filicori M, Butler JP, Crowley WF Jr. Neuroendocrine regulation of the corpus luteum in the human. Evidence for pulsatile progesterone secretion. J Clin Invest. 1984 Jun;73(6):1638-47. doi: 10.1172/JCI111370.
PubMed 6427277Ginstrom Ernstad E, Wennerholm UB, Khatibi A, Petzold M, Bergh C. Neonatal and maternal outcome after frozen embryo transfer: Increased risks in programmed cycles. Am J Obstet Gynecol. 2019 Aug;221(2):126.e1-126.e18. doi: 10.1016/j.ajog.2019.03.010. Epub 2019 Mar 22.
PubMed 30910545Pape J, Levy J, von Wolff M. Early pregnancy complications after frozen-thawed embryo transfer in different cycle regimens: A retrospective cohort study. Eur J Obstet Gynecol Reprod Biol. 2022 Dec;279:102-106. doi: 10.1016/j.ejogrb.2022.10.015. Epub 2022 Oct 21.
PubMed 36308939Roelens C, Blockeel C. Impact of different endometrial preparation protocols before frozen embryo transfer on pregnancy outcomes: a review. Fertil Steril. 2022 Nov;118(5):820-827. doi: 10.1016/j.fertnstert.2022.09.003.
PubMed 36273850Soules MR, Clifton DK, Steiner RA, Cohen NL, Bremner WJ. The corpus luteum: determinants of progesterone secretion in the normal menstrual cycle. Obstet Gynecol. 1988 May;71(5):659-66.
PubMed 3357651Su S, Zeng M, Duan J. Luteal phase support for natural cycle frozen embryo transfer: a meta-analysis. Gynecol Endocrinol. 2022 Feb;38(2):116-123. doi: 10.1080/09513590.2021.1998438. Epub 2021 Nov 3.
PubMed 34730071Practice Committee of the American Society for Reproductive Medicine. The clinical relevance of luteal phase deficiency: a committee opinion. Fertil Steril. 2012 Nov;98(5):1112-7. doi: 10.1016/j.fertnstert.2012.06.050. Epub 2012 Jul 20.
PubMed 22819186von Versen-Hoynck F, Schaub AM, Chi YY, Chiu KH, Liu J, Lingis M, Stan Williams R, Rhoton-Vlasak A, Nichols WW, Fleischmann RR, Zhang W, Winn VD, Segal MS, Conrad KP, Baker VL. Increased Preeclampsia Risk and Reduced Aortic Compliance With In Vitro Fertilization Cycles in the Absence of a Corpus Luteum. Hypertension. 2019 Mar;73(3):640-649. doi: 10.1161/HYPERTENSIONAHA.118.12043.
PubMed 30636552
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Live Birth Rate (> 24 Weeks) in Natural Cycle (NC) Single Euploid Frozen Embryo Transfers (FET) With Versus Without Luteal Phase Support (LPS)
- ClinicalTrials.gov ID
- NCT05969795
- Acronym / sponsor ID
- 2306-ABU-009-BL
- Conditions
- Pregnancy Related, Infertility, Female
- Keywords
- implantation rate, infertility, pregnancy rate, natural cycle, luteal phase support, live birth, progesterone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 1 Aug 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 evaluate whether single euploid embryo transfer in NC without routinely administered LPS is non-inferior to NC with routinely administered LPS.
Detailed description
In case the study will show that the live birth rate in single euploid NC frozen embryo transfer cycles without LPS is not inferior to NC cycles with LPS, treatment can be simplified, and participants comfort can be increased.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Other | Diagnostic Test: Transvaginal ultrasound, Diagnostic Test: Serial serum LH, E2, P4, Diagnostic Test: Serum P4 day of ET - Study Group, Procedure: Embryo transfer, Diagnostic Test: Serum hCG 10 days after ET, Diagnostic Test: Serum P4 10 days after ETIntermittent ultrasound scans to monitor follicular growth and serial measurements of serum LH, E2 and P4 levels throughout the cycle to determine ovulation. Embryo transfer (ET) will be scheduled on the fifth day after ovulation. Blood for P4 measurement will be drawn upon admission to the clinic for the ET procedure. P4 will be measured on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure. |
| Control Group | Other | Diagnostic Test: Transvaginal ultrasound, Diagnostic Test: Serial serum LH, E2, P4, Drug: Progesterone 100 Mg Vaginal Insert, Diagnostic Test: Serum P4 day of ET - Control Group, Procedure: Embryo transfer, Diagnostic Test: Serum hCG 10 days after ET, Diagnostic Test: Serum P4 10 days after ETIntermittent ultrasound scans to monitor follicular growth and serial measurements of serum LH, E2 and P4 levels throughout the cycle to determine ovulation. Embryo transfer (ET) will be scheduled on the fifth day after ovulation. Administer on FET day 200 mg of P4 and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. Blood for P4 measurement will be drawn before starting LPS in form of vaginal progesterone. P4 will be measured on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18 to 40 years
- Regular ovulatory cycles
- Availability of at least one euploid embryo after Trophectoderm biopsy for PGT-A on day 5 or day 6
- Detection of ovulation by P4 rise > 1.0 ng/ml after LH surge
- P4 value of at least 5 ng/ml on day 4 after ovulation
Key exclusion criteria (2 listed)
- History of repeated pre-menstrual spotting
- Factors affecting the implantation through anatomical changes of the uterus / ovaries or the tubes (adenomyosis, Asherman syndrome, endometriosis, uterine fibroids / polyps, isthmocele with intracavitary fluid presence, hydrosalpinx….)
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 |
|---|---|---|
| Transvaginal ultrasoundIntermittent transvaginal ultrasound throughout the cycle to monitor follicular growth | Diagnostic test | Control Group, Study Group |
| Serial serum LH, E2, P4Serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4 )levels throughout the cycle to determine ovulation. LH-surge is identified when a rise of 180% above the previous level occurred and ovulation is confirmed with a decrease in E2 concentration, and a rise of progesterone level to ≥ 1.0 ng/ml (Irani et al., 2017). | Diagnostic test | Control Group, Study Group |
| Progesterone 100 Mg Vaginal InsertAlso: Progesterone 100Mg Vag TabOn day of ET procedure, to administer 200 mg of vaginal progesterone and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy | Drug | Control Group |
| Serum P4 day of ET - Control GroupSerum P4 will be drawn before starting LPS in form of vaginal progesterone on the day of ET procedure | Diagnostic test | Control Group |
| Serum P4 day of ET - Study GroupSerum P4 will be drawn when study group participants are admitted to the clinic for the ET procedure. | Diagnostic test | Study Group |
| Embryo transferAlso: ETThe procedure in which embryo is placed in the uterus. | Procedure or surgery | Control Group, Study Group |
| Serum hCG 10 days after ETPregnancy will be confirmed / excluded by measurement of serum hCG 10 days after ET procedure and a level of > 15 IU will be regarded as positive result. The definitions of biochemical, ectopic, clinical and ongoing pregnancy follow the ICMART criteria (Zegers-Hochschild, 2006) | Diagnostic test | Control Group, Study Group |
| Serum P4 10 days after ETSerum P4 will be drawn on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure | Diagnostic test | Control Group, Study Group |
Primary outcome
Implantation rate
Time frame: 2 months
Number of embryos which have produced ultrasonographic evidence of an intrauterine gestational sac per the total number of embryos transferred into the uterine cavity (Zegers-Hochschild et al., 2009).
Clinical pregnancy rate
Time frame: 2 months
hCG > 15 Iu/ml and ultrasound confirmation of a gestational sac
Live birth rate
Time frame: 41 weeks
Number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers (Zegers-Hochschild et al., 2009)
Serum P4 levels on ET day
Time frame: 1 day
Progesterone level on the day of embryo transfer
Serum E2 and P4 levels on day 5 or 6 after ET procedure
Time frame: 6 days
Estradiol and Progesterone levels on day 5 or 6 after embryo transfer
Serum E2 and P4 levels on day 10 after ET procedure
Time frame: 10 days
Estradiol and Progesterone levels on day 10 after embryo transfer
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 9 Jan 2025.
- Background: PubMed 36171152Bortoletto P, Prabhu M, Baker VL. Association between programmed frozen embryo transfer and hypertensive disorders of pregnancy. Fertil Steril. 2022 Nov;118(5):839-848. doi: 10.1016/j.fertnstert.2022.07.025. Epub 2022 Sep 25.
- Background: PubMed 341008Csapo AI, Pulkkinen M. Indispensability of the human corpus luteum in the maintenance of early pregnancy. Luteectomy evidence. Obstet Gynecol Surv. 1978 Feb;33(2):69-81. doi: 10.1097/00006254-197802000-00001. No abstract available.
- Background: PubMed 6427277Filicori M, Butler JP, Crowley WF Jr. Neuroendocrine regulation of the corpus luteum in the human. Evidence for pulsatile progesterone secretion. J Clin Invest. 1984 Jun;73(6):1638-47. doi: 10.1172/JCI111370.
- Background: PubMed 30910545Ginstrom Ernstad E, Wennerholm UB, Khatibi A, Petzold M, Bergh C. Neonatal and maternal outcome after frozen embryo transfer: Increased risks in programmed cycles. Am J Obstet Gynecol. 2019 Aug;221(2):126.e1-126.e18. doi: 10.1016/j.ajog.2019.03.010. Epub 2019 Mar 22.
- Background: PubMed 36308939Pape J, Levy J, von Wolff M. Early pregnancy complications after frozen-thawed embryo transfer in different cycle regimens: A retrospective cohort study. Eur J Obstet Gynecol Reprod Biol. 2022 Dec;279:102-106. doi: 10.1016/j.ejogrb.2022.10.015. Epub 2022 Oct 21.
- Background: PubMed 36273850Roelens C, Blockeel C. Impact of different endometrial preparation protocols before frozen embryo transfer on pregnancy outcomes: a review. Fertil Steril. 2022 Nov;118(5):820-827. doi: 10.1016/j.fertnstert.2022.09.003.
- Background: PubMed 3357651Soules MR, Clifton DK, Steiner RA, Cohen NL, Bremner WJ. The corpus luteum: determinants of progesterone secretion in the normal menstrual cycle. Obstet Gynecol. 1988 May;71(5):659-66.
- Background: PubMed 34730071Su S, Zeng M, Duan J. Luteal phase support for natural cycle frozen embryo transfer: a meta-analysis. Gynecol Endocrinol. 2022 Feb;38(2):116-123. doi: 10.1080/09513590.2021.1998438. Epub 2021 Nov 3.
- Background: PubMed 22819186Practice Committee of the American Society for Reproductive Medicine. The clinical relevance of luteal phase deficiency: a committee opinion. Fertil Steril. 2012 Nov;98(5):1112-7. doi: 10.1016/j.fertnstert.2012.06.050. Epub 2012 Jul 20.
- Background: PubMed 30636552von Versen-Hoynck F, Schaub AM, Chi YY, Chiu KH, Liu J, Lingis M, Stan Williams R, Rhoton-Vlasak A, Nichols WW, Fleischmann RR, Zhang W, Winn VD, Segal MS, Conrad KP, Baker VL. Increased Preeclampsia Risk and Reduced Aortic Compliance With In Vitro Fertilization Cycles in the Absence of a Corpus Luteum. Hypertension. 2019 Mar;73(3):640-649. doi: 10.1161/HYPERTENSIONAHA.118.12043.
- Shapiro BS, Garner FC, Aguirre M. The Freeze-All Cycle: A New Paradigm Shift in ART. In Nagy ZP, Varghese AC, Agarwal A, editors. In Vitro Fertilization \[Internet\] 2019;, p. 765-778. Springer International PublishingLink provided by the sponsor.
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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.
Barbara Lawrenz, PhD principal investigator
ART Fertility Clinics LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transvaginal ultrasound, Serial serum LH, E2, P4 and Progesterone 100 Mg Vaginal Insert in people with Pregnancy Related and Infertility, Female, run by ART Fertility Clinics LLC at 3 sites 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 2 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 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (+971 800 337845489, barbara.lawrenz@artfertilityclinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation rate (time frame: 2 months). 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 NCT05969795, which also lists 10 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 9 Jan 2025.