Endometrial ReceptivityNCT03887728
Comparison of Blood Flow in the Arteriae Uterinae in Ovarian Stimulation Cycles
An observational study of Endometrial Receptivity, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial summary
This study will measure the blood flow in the aa. uterinae in women, undergoing firstly ovarian stimulation for In-Vitro Fertilization (IVF) / Intracytoplasmic sperm injection (ICSI), in Hormonal Replacement cycles (HRT) and Natural cycles (NC) for Frozen Embryo Transfer (FET) Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Receptivity
- Type of treatment
- Pill or oral medicine
- How many people
- 124 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 23 Apr 2019to 14 Dec 2020
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with primary / secondary infertility, who undergo an ovarian stimulation treatment for IVF/ICSI and subsequently are planned for FET with vitrified embryos, either as HRT-FET or as NC-FET
Who may be able to join
- Patients who undergo ovarian stimulation in a Gonadotropin-Releasing-Hormone (GnRH)-antagonist protocol for IVF / ICSI
- Patients who have vitrified embryo(s)
- Preparation for FET either in HRT or NC cycle
Who cannot join
- Poor responder according to Bologna criteria (Ferraretti et al.) as follows:
- At least two of the following three features must be present:
- (i) Advanced maternal age (≥40 years) or any other risk factor for poor ovarian reserve (POR);
- (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol);
- (iii) An abnormal ovarian reserve test (i.e. antral follicle count (AFC) 5-7 follicles or anti-mullerian hormone (AMH) 0.5 -1.1 ng/ml).
- Uterine surgery for removal of fibroids (hysteroscopic, laparoscopic) or removal of uterine septum
Show all 14Show fewer
- Endometriosis
- Asherman-Syndrome
- Previous cytotoxic treatment
- Previous radiation of the uterus / adnexal region
- Known hypertension
- Intake of Aspirin or similar medication which might influence the blood flow
- Status after tubal ligation
- Status after surgery in the adnexal region on 1 side
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
IVI Middle East Fertility Clinic
Abu Dhabi, 60202
About this study
Official title: Comparison of Blood Flow in the Arteriae Uterinae in Ovarian Stimulation Cycles for IVF/ICSI, in Hormonal Replacement Cycles and Natural Cycles for Frozen Embryo Transfer
This study will measure the blood flow in the aa. uterinae in women, undergoing firstly ovarian stimulation for In-Vitro Fertilization (IVF) / Intracytoplasmic sperm injection (ICSI), in Hormonal Replacement cycles (HRT) and Natural cycles (NC) for Frozen Embryo Transfer (FET)
Read the detailed description
To evaluate the influence of ovarian stimulation on the blood flow in the arteriae uterinae as well as whether there is an influence of the type of endometrial preparation for FET with either hormonal replacement therapy or natural cycle on the blood flow of the arteria uterina left / right
- Conditions
- Endometrial Receptivity
- Keywords
- progesterone, endometrium, blood flow, estradiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Artificial (HRT) Cycles | 1. Commence estradiol tablets (E2) 4mg from day 2 or 3 of period for 3 days 2. Increase E2 to 6mg on day 4 of E2 treatment, according to clinician discretion based on endometrial thickness. 3. Transvaginal scan throughout the HRT cycle to not only monitor endometrial development but to also exclude the presence of a dominant follicle on the ovaries. 4. Serial measurements of serum LH (luteinizing hormone), estradiol and progesterone levels. 5. Initial progesterone dose of 100mg at 22hrs (vaginal suppository) after ≥ 10 days and ≤ 16 days of estradiol administration when the minimal endometrial thickness achieved is 6mm with a trilaminar appearance. 6. Subsequently increase progesterone administration to 100mg vaginally three times daily. Continue E2 administration 6mg (3 tablets daily). Embryo transfer is scheduled 5 days following the initial initiation of progesterone | |
| Spontaneous natural cycles | 1. Day 2 of menses and throughout patients' natural cycle scans to monitor follicular growth. 2. Measurements of serum LH, estradiol and progesterone levels to determine ovulation. 3. The LH surge will be considered to have begun when the concentration rises by 180% above the most recent serum value and continues to rise thereafter (Irani et al. 2017, Fatemi et al., 2010). 4. Day 1 after the LH rise, a decrease in estradiol concentration is identified. Twenty four hours later progesterone concentrations rise with a level of greater than or equal to 1.5nmol /L confirming ovulation (day 0) (Irani et al., 2017; Speroff et al.). This is considered as day 0 with initiation of vaginal progesterone 100mg at 22hrs that night. The following day (day 1) the patient increases progesterone administration to 100mg vaginally 8 hourly and continues until 7 weeks gestation as per clinic protocol. Embryo transfer is scheduled 5 days (day 5) following confirmation of ovulation (day 0). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the blood flow, calculated as Pulsatility Index (PI) and Resistance Index (RI), between the HRT- and the NC-FET cycles
On the day of progesterone administration / progesterone rise. Quantitative continuous variable
Measured: 1 day
Secondary outcomes (4)
Continuous quantitative variable measured as the differences between average PI value
On the day of cycle start and the day of ovulation induction. Continuous quantitative variable measured in millimeters (mm)
Measured: 1 day
Continuous quantitative variable measured as the differences between average RI value
On the day of cycle start and the day of ovulation induction
Measured: 2 days
Thickness of the lining
Continuous quantitative variable measured in millimeters (mm)
Measured: 1 day
Number of days of estradiol exposure
Before the embryo transfer
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 posted25 Mar 2019
- Study start23 Apr 2019
- Primary completion26 Sep 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Endometrial ReceptivityStudies 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
- 124 participants (actual)
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, IVI RMA Abu Dhabi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887728
- Sponsor's protocol ID
- 1901-ABU-002-BL
- Status last verified
- Jan 2021
- First submitted
- 19 Mar 2019
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdalla HI, Brooks AA, Johnson MR, Kirkland A, Thomas A, Studd JW. Endometrial thickness: a predictor of implantation in ovum recipients? Hum Reprod. 1994 Feb;9(2):363-5. doi: 10.1093/oxfordjournals.humrep.a138509.
PubMed 8027298Noyes N, Liu HC, Sultan K, Schattman G, Rosenwaks Z. Endometrial thickness appears to be a significant factor in embryo implantation in in-vitro fertilization. Hum Reprod. 1995 Apr;10(4):919-22. doi: 10.1093/oxfordjournals.humrep.a136061.
PubMed 7650143Bakos O, Lundkvist O, Bergh T. Transvaginal sonographic evaluation of endometrial growth and texture in spontaneous ovulatory cycles--a descriptive study. Hum Reprod. 1993 Jun;8(6):799-806. doi: 10.1093/oxfordjournals.humrep.a138145.
PubMed 8345066Tekay A, Martikainen H, Jouppila P. Comparison of uterine blood flow characteristics between spontaneous and stimulated cycles before embryo transfer. Hum Reprod. 1996 Feb;11(2):364-8. doi: 10.1093/humrep/11.2.364.
PubMed 8671225Romero R. Giants in Obstetrics and Gynecology Series: A profile of Leon Speroff, MD. Am J Obstet Gynecol. 2017 Sep;217(3):263.e1-263.e8. doi: 10.1016/j.ajog.2017.05.056. Epub 2017 Jul 12. No abstract available.
PubMed 28710912Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.
PubMed 21505041Irani M, Robles A, Gunnala V, Reichman D, Rosenwaks Z. Optimal parameters for determining the LH surge in natural cycle frozen-thawed embryo transfers. J Ovarian Res. 2017 Oct 16;10(1):70. doi: 10.1186/s13048-017-0367-7.
PubMed 29037231Fatemi HM, Kyrou D, Bourgain C, Van den Abbeel E, Griesinger G, Devroey P. Cryopreserved-thawed human embryo transfer: spontaneous natural cycle is superior to human chorionic gonadotropin-induced natural cycle. Fertil Steril. 2010 Nov;94(6):2054-8. doi: 10.1016/j.fertnstert.2009.11.036. Epub 2010 Jan 25.
PubMed 20097333
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blood Flow in the Arteriae Uterinae in Ovarian Stimulation Cycles for IVF/ICSI, in Hormonal Replacement Cycles and Natural Cycles for Frozen Embryo Transfer
- ClinicalTrials.gov ID
- NCT03887728
- Acronym / sponsor ID
- 1901-ABU-002-BL
- Conditions
- Endometrial Receptivity
- Keywords
- progesterone, endometrium, blood flow, estradiol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 26 Sep 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 25 Mar 2019 (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.
This study will measure the blood flow in the aa. uterinae in women, undergoing firstly ovarian stimulation for In-Vitro Fertilization (IVF) / Intracytoplasmic sperm injection (ICSI), in Hormonal Replacement cycles (HRT) and Natural cycles (NC) for Frozen Embryo Transfer (FET)
Detailed description
To evaluate the influence of ovarian stimulation on the blood flow in the arteriae uterinae as well as whether there is an influence of the type of endometrial preparation for FET with either hormonal replacement therapy or natural cycle on the blood flow of the arteria uterina left / right
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial (HRT) Cycles | – | –1. Commence estradiol tablets (E2) 4mg from day 2 or 3 of period for 3 days 2. Increase E2 to 6mg on day 4 of E2 treatment, according to clinician discretion based on endometrial thickness. 3. Transvaginal scan throughout the HRT cycle to not only monitor endometrial development but to also exclude the presence of a dominant follicle on the ovaries. 4. Serial measurements of serum LH (luteinizing hormone), estradiol and progesterone levels. 5. Initial progesterone dose of 100mg at 22hrs (vaginal suppository) after ≥ 10 days and ≤ 16 days of estradiol administration when the minimal endometrial thickness achieved is 6mm with a trilaminar appearance. 6. Subsequently increase progesterone administration to 100mg vaginally three times daily. Continue E2 administration 6mg (3 tablets daily). Embryo transfer is scheduled 5 days following the initial initiation of progesterone |
| Spontaneous natural cycles | – | –1. Day 2 of menses and throughout patients' natural cycle scans to monitor follicular growth. 2. Measurements of serum LH, estradiol and progesterone levels to determine ovulation. 3. The LH surge will be considered to have begun when the concentration rises by 180% above the most recent serum value and continues to rise thereafter (Irani et al. 2017, Fatemi et al., 2010). 4. Day 1 after the LH rise, a decrease in estradiol concentration is identified. Twenty four hours later progesterone concentrations rise with a level of greater than or equal to 1.5nmol /L confirming ovulation (day 0) (Irani et al., 2017; Speroff et al.). This is considered as day 0 with initiation of vaginal progesterone 100mg at 22hrs that night. The following day (day 1) the patient increases progesterone administration to 100mg vaginally 8 hourly and continues until 7 weeks gestation as per clinic protocol. Embryo transfer is scheduled 5 days (day 5) following confirmation of ovulation (day 0). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with primary / secondary infertility, who undergo an ovarian stimulation treatment for IVF/ICSI and subsequently are planned for FET with vitrified embryos, either as HRT-FET or as NC-FET
Key inclusion criteria (3 listed)
- Patients who undergo ovarian stimulation in a Gonadotropin-Releasing-Hormone (GnRH)-antagonist protocol for IVF / ICSI
- Patients who have vitrified embryo(s)
- Preparation for FET either in HRT or NC cycle
Key exclusion criteria (14 listed)
- Poor responder according to Bologna criteria (Ferraretti et al.) as follows:
- At least two of the following three features must be present:
- (i) Advanced maternal age (≥40 years) or any other risk factor for poor ovarian reserve (POR);
- (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol);
- (iii) An abnormal ovarian reserve test (i.e. antral follicle count (AFC) 5-7 follicles or anti-mullerian hormone (AMH) 0.5 -1.1 ng/ml).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in the blood flow, calculated as Pulsatility Index (PI) and Resistance Index (RI), between the HRT- and the NC-FET cycles
Time frame: 1 day
On the day of progesterone administration / progesterone rise. Quantitative continuous variable
4 secondary outcomes
Continuous quantitative variable measured as the differences between average PI value
Time frame: 1 day
Continuous quantitative variable measured as the differences between average RI value
Time frame: 2 days
Thickness of the lining
Time frame: 1 day
Number of days of estradiol exposure
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Background: PubMed 8027298Abdalla HI, Brooks AA, Johnson MR, Kirkland A, Thomas A, Studd JW. Endometrial thickness: a predictor of implantation in ovum recipients? Hum Reprod. 1994 Feb;9(2):363-5. doi: 10.1093/oxfordjournals.humrep.a138509.
- Background: PubMed 7650143Noyes N, Liu HC, Sultan K, Schattman G, Rosenwaks Z. Endometrial thickness appears to be a significant factor in embryo implantation in in-vitro fertilization. Hum Reprod. 1995 Apr;10(4):919-22. doi: 10.1093/oxfordjournals.humrep.a136061.
- Background: PubMed 8345066Bakos O, Lundkvist O, Bergh T. Transvaginal sonographic evaluation of endometrial growth and texture in spontaneous ovulatory cycles--a descriptive study. Hum Reprod. 1993 Jun;8(6):799-806. doi: 10.1093/oxfordjournals.humrep.a138145.
- Background: PubMed 8671225Tekay A, Martikainen H, Jouppila P. Comparison of uterine blood flow characteristics between spontaneous and stimulated cycles before embryo transfer. Hum Reprod. 1996 Feb;11(2):364-8. doi: 10.1093/humrep/11.2.364.
- Background: PubMed 28710912Romero R. Giants in Obstetrics and Gynecology Series: A profile of Leon Speroff, MD. Am J Obstet Gynecol. 2017 Sep;217(3):263.e1-263.e8. doi: 10.1016/j.ajog.2017.05.056. Epub 2017 Jul 12. No abstract available.
- Background: PubMed 21505041Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.
- Results publication: PubMed 29037231Irani M, Robles A, Gunnala V, Reichman D, Rosenwaks Z. Optimal parameters for determining the LH surge in natural cycle frozen-thawed embryo transfers. J Ovarian Res. 2017 Oct 16;10(1):70. doi: 10.1186/s13048-017-0367-7.
- Results publication: PubMed 20097333Fatemi HM, Kyrou D, Bourgain C, Van den Abbeel E, Griesinger G, Devroey P. Cryopreserved-thawed human embryo transfer: spontaneous natural cycle is superior to human chorionic gonadotropin-induced natural cycle. Fertil Steril. 2010 Nov;94(6):2054-8. doi: 10.1016/j.fertnstert.2009.11.036. Epub 2010 Jan 25.
- Individual participant dataSharing planned: No
Related trials for Endometrial Receptivity
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
Not yet recruitingObservational study
Endometrial Immune Profile in Recurrent Implantation Failure
Recurrent Implantation Failure, Infertility (IVF Patients)
RecruitingObservational study
Artificial Intelligence Into Ultrasound Diagnostics in Reproductive Medicine
Endometriosis, Adenomyosis of Uterus
RecruitingObservational study
Impact of IVF Hormonal Therapy on Endometrial Receptivity and Endometrial Senescent Cell Pathological Accumulation
Endometrial Receptivity
Not yet recruitingObservational study
ERA in Young Primary Infertile RIF Patients
Recurrent Implantation Failure
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.
Barbara Lawrenz, PhD principal investigator
IVI RMA Abu Dhabi
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 Endometrial Receptivity, 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 3 inclusion and 14 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: finished, as of the sponsor's last update on 8 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in the blood flow, calculated as Pulsatility Index (PI) and Resistance Index (RI), between the HRT- and the NC-FET cycles (time frame: 1 day). 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 NCT03887728, which also lists 8 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 8 Jan 2021.