Endometrial DisorderNCT04454749
Endometrial Compaction and Its Influence on Pregnancy Rate in Frozen Embryo Cycle Regimes
An observational study of Endometrial Disorder and Infertility, Female, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial summary
For a pregnancy to occur, an euploid embryo at blastocyst developmental stage, a receptive endometrium and the synchrony of both is crucial. Many studies lately investigated the influence of the endometrial thickness and pattern on the artificial reproductive technology (ART) outcome, however, with conflicting results. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometrial Disorder, Infertility, Female, IVF
- What is being tested?
- Blood test and Ultrasound
- Type of treatment
- Pill or oral medicine
- How many people
- 3 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 9 Nov 2020to 4 Mar 2021
- 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 18 to 40 years
- Women only
- Adult
Study population: Patients who are undergoing ovarian stimulation for IVF/ICSI with pre-implantation genetic screening and embryo vitrification, who are planned for their first FET transfer cycle.
Who may be able to join
- Women aged 18 years to 40 years with regular menses (26-34 days)
- Having 1 or 2 chromosomally normal cryopreserved blastocysts available for transfer after IVF / ICSI treatment
- First frozen-thawed transfer cycle
- Progesterone level < 1.5 ng/mL day of trigger injection in stimulation cycle from which embryos to be transferred were created.
Who cannot join
- Polycystic ovarian syndrome
- Poor ovarian responder in accordance with Bologna criteria
- Uterine abnormality US / saline infusion sonohysterogram
- Previous dilatation \& curettage (D\&C)
- Hydrosalpinx
- Asherman syndrome
Show all 14Show fewer
- History of endometriosis AFS ≥ 2
- ICSI due to severe male factor with testicular sperm
- Any known contraindications or allergy to oral estradiol or progesterone.
- Discontinuation of HRT medication ( medication error in research HRT cycle )
- Failure to detect ovulation in the research natural cycle
- Ovulation after day 20 in a natural cycle
- Duration of estradiol exposure ≥ 17 days and endometrium < 6mm
- Spontaneous ovulation in HRT artificial cycle
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
IVI Middle East Fertility Clinic
Abu Dhabi, 60202
About this study
For a pregnancy to occur, an euploid embryo at blastocyst developmental stage, a receptive endometrium and the synchrony of both is crucial. Many studies lately investigated the influence of the endometrial thickness and pattern on the artificial reproductive technology (ART) outcome, however, with conflicting results.
Read the detailed description
Further on, the measurement of the endometrial thickness was mostly performed either on the day of final oocyte maturation in stimulated cycles with fresh embryo transfer or on the day of progesterone administration in FET cycles.
Progesterone is essential for the secretory transformation and compaction of the endometrium, prior to implantation. A recently published paper (Haas et al., 2019) however, evaluated the degree of endometrial compaction under the influence of progesterone in FET cycles and described, that a lack of certain endometrial compaction has a negative impact on the ongoing pregnancy rate. As in this study embryos of unknown ploidy status were transferred, the role of embryo ploidy on the outcome may bias the study results.
In the herein presented study protocol we aim to investigate the influence of endometrial compaction in FET cycles in which euploid embryos are transferred.
HYPOTHESIS: Lack of endometrial compaction after the start of progesterone leads to an impaired reproductive outcome.
- Conditions
- Endometrial Disorder, Infertility, Female, IVF, Pregnancy Early
- Being tested
- Blood test, Ultrasound
- Keywords
- infertilty, progesterone, endometrium, pregnancy
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDiagnostic test
Mesurement of E2, P4, LH, FSH hormones
UltrasoundDiagnostic test
Follicular measurement and endometrium measurement
| Study group | Role | What they receive |
|---|---|---|
| Stimulated cycles | Ovarian stimulation will be performed by standard protocols. Stimulation medication dosage will be individualised prior to stimulation start according to the ovarian reserve parameters and during ovarian stimulation according to the ovarian response and the measured levels of E2 and progesterone (P4), in order to avoid progesterone elevation during late follicular phase. Final oocyte maturation will be achieved by administration of either 10.000 IU of hCG, 0.3 mg of GnRH agonist (Triptorelin) or dual trigger (hCG and GnRH-analogue), as soon as ≥ 3 follicles ≥ 17 mm are present. Oocyte retrieval will be carried out 36 hours after administration of the trigger. Embryos will undergo PGT-A at blastocyst stage and be vitrified thereafter. Receives: Diagnostic Test: Blood test; Diagnostic Test: Ultrasound | |
| Artificial (HRT) Cycles | Start of estradiol valerate 4mg on day 2 of the cycle for three days. Increase E2 to 6mg on day 4 of E2 treatment. E2 dose may be increased according to clinician discretion based on endometrial thickness. Maximum time of E2 exposure will be 14 days. Transvaginally scan to monitor endometrial development and to exclude the presence of a dominant follicle. Serial measurements of serum LH, estradiol and progesterone levels. Commence the initial progesterone dose of 100mg at 22hrs (vaginal suppository) after ≥ 7 days and ≤ 16 days of estradiol administration when the minimal endometrial thickness achieved is 6mm with a trilaminar appearance. Subsequently increase progesterone administration to 100mg vaginally three times daily. Continue estradiol administration 6mg (3 tablets daily).
Blastocyst transfer is scheduled on the 5th full day of progesterone administration, following the initial initiation of progesterone. Receives: Diagnostic Test: Blood test; Diagnostic Test: Ultrasound | |
| Spontaneous natural cycles | Ultrasound scans to monitor follicular growth and serial measurements of serum LH, estradiol and progesterone levels to determine the timing of ovulation. 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.
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 1.5ng/ml confirming ovulation (day 0). This is considered as day 0 with initiation of vaginal progesterone 100mg (vaginal suppository) at 2200H. The following day (day 1) increases progesterone administration to 100mg vaginally three times daily (8 hourly) and continues this regime until 7 weeks gestation as per clinic protocol.
Embryo transfer is scheduled 5 days (day 5) following confirmation of ovulation (day 0). Receives: Diagnostic Test: Blood test; Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Ongoing pregnancy rate (≥ 12 weeks) in patients with endometrial compaction compared to patients without endometrial compaction after frozen embryo transfer of 1 or 2 euploid blastocysts
Measured: 12 weeks
Secondary outcomes (4)
Biochemical pregnancy rate in HRT cycle
Positive hCG, but at 5 gestational weeks no ultrasonographic visible gestational sac seen after embryo transfer in HRT-FET cycles with one or two euploid embryos, depending on the degree of compaction.
Measured: 5 weeks
Biochemical pregnancy rate in spontaneous cycle
positive hCG, but at 5 gestational weeks no ultrasonographic visible gestational sac seen) after embryo transfer in NC-FET cycles with one or two euploid embryos, depending on the degree of compaction.
Measured: 5 weeks
Clinical implantation rate in HRT cycle
Number of gestational sacs observed by ultrasound at 6 weeks of gestation divided by the number of embryos transferred), defined by a ß-hCG of > 5 IU on day 12 after embryo transfer in HRT-FET cycles with one or two euploid embryos, depending on the degree of compaction
Measured: 6 weeks
Clinical implantation rate in spontaneous cycle
Number of gestational sacs observed by ultrasound at 6 weeks of gestation divided by the number of embryos transferred), defined by a ß-hCG of > 5 IU on day 12 after embryo transfer in NC-FET cycles with one or two euploid embryos, depending on the degree of compaction.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start9 Nov 2020
- Primary completion25 Feb 2021
- Study completion4 Mar 2021
Why it stopped: Investigators perogative
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Endometrial DisorderStudies 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
- 3 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 Middle East Fertility Clinic LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454749
- Sponsor's protocol ID
- 2003-ABU-002-BL
- Status last verified
- Mar 2021
- First submitted
- 28 Jun 2020
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bu Z, Sun Y. The Impact of Endometrial Thickness on the Day of Human Chorionic Gonadotrophin (hCG) Administration on Ongoing Pregnancy Rate in Patients with Different Ovarian Response. PLoS One. 2015 Dec 30;10(12):e0145703. doi: 10.1371/journal.pone.0145703. eCollection 2015.
PubMed 26717148Fatemi 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 20097333Haas J, Smith R, Zilberberg E, Nayot D, Meriano J, Barzilay E, Casper RF. Endometrial compaction (decreased thickness) in response to progesterone results in optimal pregnancy outcome in frozen-thawed embryo transfers. Fertil Steril. 2019 Sep;112(3):503-509.e1. doi: 10.1016/j.fertnstert.2019.05.001. Epub 2019 Jun 24.
PubMed 31248618Irani 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 29037231Kasius A, Smit JG, Torrance HL, Eijkemans MJ, Mol BW, Opmeer BC, Broekmans FJ. Endometrial thickness and pregnancy rates after IVF: a systematic review and meta-analysis. Hum Reprod Update. 2014 Jul-Aug;20(4):530-41. doi: 10.1093/humupd/dmu011. Epub 2014 Mar 23.
PubMed 24664156La Marca A, Sunkara SK. Individualization of controlled ovarian stimulation in IVF using ovarian reserve markers: from theory to practice. Hum Reprod Update. 2014 Jan-Feb;20(1):124-40. doi: 10.1093/humupd/dmt037. Epub 2013 Sep 29.
PubMed 24077980Lawrenz B, Labarta E, Fatemi H, Bosch E. Premature progesterone elevation: targets and rescue strategies. Fertil Steril. 2018 Apr;109(4):577-582. doi: 10.1016/j.fertnstert.2018.02.128.
PubMed 29653703Liu KE, Hartman M, Hartman A, Luo ZC, Mahutte N. The impact of a thin endometrial lining on fresh and frozen-thaw IVF outcomes: an analysis of over 40 000 embryo transfers. Hum Reprod. 2018 Oct 1;33(10):1883-1888. doi: 10.1093/humrep/dey281.
PubMed 30239738Liu Y, Ye XY, Chan C. The association between endometrial thickness and pregnancy outcome in gonadotropin-stimulated intrauterine insemination cycles. Reprod Biol Endocrinol. 2019 Jan 23;17(1):14. doi: 10.1186/s12958-019-0455-1.
PubMed 30674305Testart J, Frydman R, Feinstein MC, Thebault A, Roger M, Scholler R. Interpretation of plasma luteinizing hormone assay for the collection of mature oocytes from women: definition of a luteinizing hormone surge-initiating rise. Fertil Steril. 1981 Jul;36(1):50-4. doi: 10.1016/s0015-0282(16)45617-7.
PubMed 7250407Vaegter KK, Lakic TG, Olovsson M, Berglund L, Brodin T, Holte J. Which factors are most predictive for live birth after in vitro fertilization and intracytoplasmic sperm injection (IVF/ICSI) treatments? Analysis of 100 prospectively recorded variables in 8,400 IVF/ICSI single-embryo transfers. Fertil Steril. 2017 Mar;107(3):641-648.e2. doi: 10.1016/j.fertnstert.2016.12.005. Epub 2017 Jan 17.
PubMed 28108009Yuan X, Saravelos SH, Wang Q, Xu Y, Li TC, Zhou C. Endometrial thickness as a predictor of pregnancy outcomes in 10787 fresh IVF-ICSI cycles. Reprod Biomed Online. 2016 Aug;33(2):197-205. doi: 10.1016/j.rbmo.2016.05.002. Epub 2016 May 13.
PubMed 27238372Zhao J, Zhang Q, Wang Y, Li Y. Endometrial pattern, thickness and growth in predicting pregnancy outcome following 3319 IVF cycle. Reprod Biomed Online. 2014 Sep;29(3):291-8. doi: 10.1016/j.rbmo.2014.05.011. Epub 2014 Jun 13.
PubMed 25070912
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Compaction and Its Influence on Pregnancy Rate in Frozen Embryo Cycle Regimes
- ClinicalTrials.gov ID
- NCT04454749
- Acronym / sponsor ID
- 2003-ABU-002-BL
- Conditions
- Endometrial Disorder, Infertility, Female, IVF, Pregnancy Early
- Keywords
- infertilty, progesterone, endometrium, pregnancy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigators perogative
- Enrolment
- 3 participants (actual)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 1 Jul 2020 (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.
For a pregnancy to occur, an euploid embryo at blastocyst developmental stage, a receptive endometrium and the synchrony of both is crucial. Many studies lately investigated the influence of the endometrial thickness and pattern on the artificial reproductive technology (ART) outcome, however, with conflicting results.
Detailed description
Further on, the measurement of the endometrial thickness was mostly performed either on the day of final oocyte maturation in stimulated cycles with fresh embryo transfer or on the day of progesterone administration in FET cycles.
Progesterone is essential for the secretory transformation and compaction of the endometrium, prior to implantation. A recently published paper (Haas et al., 2019) however, evaluated the degree of endometrial compaction under the influence of progesterone in FET cycles and described, that a lack of certain endometrial compaction has a negative impact on the ongoing pregnancy rate. As in this study embryos of unknown ploidy status were transferred, the role of embryo ploidy on the outcome may bias the study results.
In the herein presented study protocol we aim to investigate the influence of endometrial compaction in FET cycles in which euploid embryos are transferred.
HYPOTHESIS: Lack of endometrial compaction after the start of progesterone leads to an impaired reproductive outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stimulated cycles | – | Diagnostic Test: Blood test, Diagnostic Test: UltrasoundOvarian stimulation will be performed by standard protocols. Stimulation medication dosage will be individualised prior to stimulation start according to the ovarian reserve parameters and during ovarian stimulation according to the ovarian response and the measured levels of E2 and progesterone (P4), in order to avoid progesterone elevation during late follicular phase. Final oocyte maturation will be achieved by administration of either 10.000 IU of hCG, 0.3 mg of GnRH agonist (Triptorelin) or dual trigger (hCG and GnRH-analogue), as soon as ≥ 3 follicles ≥ 17 mm are present. Oocyte retrieval will be carried out 36 hours after administration of the trigger. Embryos will undergo PGT-A at blastocyst stage and be vitrified thereafter. |
| Artificial (HRT) Cycles | – | Diagnostic Test: Blood test, Diagnostic Test: UltrasoundStart of estradiol valerate 4mg on day 2 of the cycle for three days. Increase E2 to 6mg on day 4 of E2 treatment. E2 dose may be increased according to clinician discretion based on endometrial thickness. Maximum time of E2 exposure will be 14 days. Transvaginally scan to monitor endometrial development and to exclude the presence of a dominant follicle. Serial measurements of serum LH, estradiol and progesterone levels. Commence the initial progesterone dose of 100mg at 22hrs (vaginal suppository) after ≥ 7 days and ≤ 16 days of estradiol administration when the minimal endometrial thickness achieved is 6mm with a trilaminar appearance. Subsequently increase progesterone administration to 100mg vaginally three times daily. Continue estradiol administration 6mg (3 tablets daily). Blastocyst transfer is scheduled on the 5th full day of progesterone administration, following the initial initiation of progesterone. |
| Spontaneous natural cycles | – | Diagnostic Test: Blood test, Diagnostic Test: UltrasoundUltrasound scans to monitor follicular growth and serial measurements of serum LH, estradiol and progesterone levels to determine the timing of ovulation. 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. 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 1.5ng/ml confirming ovulation (day 0). This is considered as day 0 with initiation of vaginal progesterone 100mg (vaginal suppository) at 2200H. The following day (day 1) increases progesterone administration to 100mg vaginally three times daily (8 hourly) and continues this regime 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
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients who are undergoing ovarian stimulation for IVF/ICSI with pre-implantation genetic screening and embryo vitrification, who are planned for their first FET transfer cycle.
Key inclusion criteria (4 listed)
- Women aged 18 years to 40 years with regular menses (26-34 days)
- Having 1 or 2 chromosomally normal cryopreserved blastocysts available for transfer after IVF / ICSI treatment
- First frozen-thawed transfer cycle
- Progesterone level < 1.5 ng/mL day of trigger injection in stimulation cycle from which embryos to be transferred were created.
Key exclusion criteria (14 listed)
- Polycystic ovarian syndrome
- Poor ovarian responder in accordance with Bologna criteria
- Uterine abnormality US / saline infusion sonohysterogram
- Previous dilatation \& curettage (D\&C)
- 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 |
|---|---|---|
| Blood testMesurement of E2, P4, LH, FSH hormones | Diagnostic test | Artificial (HRT) Cycles, Spontaneous natural cycles, Stimulated cycles |
| UltrasoundFollicular measurement and endometrium measurement | Diagnostic test | Artificial (HRT) Cycles, Spontaneous natural cycles, Stimulated cycles |
Primary outcome
Ongoing pregnancy rate
Time frame: 12 weeks
Ongoing pregnancy rate (≥ 12 weeks) in patients with endometrial compaction compared to patients without endometrial compaction after frozen embryo transfer of 1 or 2 euploid blastocysts
4 secondary outcomes
Biochemical pregnancy rate in HRT cycle
Time frame: 5 weeks
Biochemical pregnancy rate in spontaneous cycle
Time frame: 5 weeks
Clinical implantation rate in HRT cycle
Time frame: 6 weeks
Clinical implantation rate in spontaneous cycle
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Investigators perogative). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Results publication: PubMed 26717148Bu Z, Sun Y. The Impact of Endometrial Thickness on the Day of Human Chorionic Gonadotrophin (hCG) Administration on Ongoing Pregnancy Rate in Patients with Different Ovarian Response. PLoS One. 2015 Dec 30;10(12):e0145703. doi: 10.1371/journal.pone.0145703. eCollection 2015.
- 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.
- Results publication: PubMed 31248618Haas J, Smith R, Zilberberg E, Nayot D, Meriano J, Barzilay E, Casper RF. Endometrial compaction (decreased thickness) in response to progesterone results in optimal pregnancy outcome in frozen-thawed embryo transfers. Fertil Steril. 2019 Sep;112(3):503-509.e1. doi: 10.1016/j.fertnstert.2019.05.001. Epub 2019 Jun 24.
- 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 24664156Kasius A, Smit JG, Torrance HL, Eijkemans MJ, Mol BW, Opmeer BC, Broekmans FJ. Endometrial thickness and pregnancy rates after IVF: a systematic review and meta-analysis. Hum Reprod Update. 2014 Jul-Aug;20(4):530-41. doi: 10.1093/humupd/dmu011. Epub 2014 Mar 23.
- Results publication: PubMed 24077980La Marca A, Sunkara SK. Individualization of controlled ovarian stimulation in IVF using ovarian reserve markers: from theory to practice. Hum Reprod Update. 2014 Jan-Feb;20(1):124-40. doi: 10.1093/humupd/dmt037. Epub 2013 Sep 29.
- Results publication: PubMed 29653703Lawrenz B, Labarta E, Fatemi H, Bosch E. Premature progesterone elevation: targets and rescue strategies. Fertil Steril. 2018 Apr;109(4):577-582. doi: 10.1016/j.fertnstert.2018.02.128.
- Results publication: PubMed 30239738Liu KE, Hartman M, Hartman A, Luo ZC, Mahutte N. The impact of a thin endometrial lining on fresh and frozen-thaw IVF outcomes: an analysis of over 40 000 embryo transfers. Hum Reprod. 2018 Oct 1;33(10):1883-1888. doi: 10.1093/humrep/dey281.
- Results publication: PubMed 30674305Liu Y, Ye XY, Chan C. The association between endometrial thickness and pregnancy outcome in gonadotropin-stimulated intrauterine insemination cycles. Reprod Biol Endocrinol. 2019 Jan 23;17(1):14. doi: 10.1186/s12958-019-0455-1.
- Results publication: PubMed 7250407Testart J, Frydman R, Feinstein MC, Thebault A, Roger M, Scholler R. Interpretation of plasma luteinizing hormone assay for the collection of mature oocytes from women: definition of a luteinizing hormone surge-initiating rise. Fertil Steril. 1981 Jul;36(1):50-4. doi: 10.1016/s0015-0282(16)45617-7.
- Results publication: PubMed 28108009Vaegter KK, Lakic TG, Olovsson M, Berglund L, Brodin T, Holte J. Which factors are most predictive for live birth after in vitro fertilization and intracytoplasmic sperm injection (IVF/ICSI) treatments? Analysis of 100 prospectively recorded variables in 8,400 IVF/ICSI single-embryo transfers. Fertil Steril. 2017 Mar;107(3):641-648.e2. doi: 10.1016/j.fertnstert.2016.12.005. Epub 2017 Jan 17.
- Results publication: PubMed 27238372Yuan X, Saravelos SH, Wang Q, Xu Y, Li TC, Zhou C. Endometrial thickness as a predictor of pregnancy outcomes in 10787 fresh IVF-ICSI cycles. Reprod Biomed Online. 2016 Aug;33(2):197-205. doi: 10.1016/j.rbmo.2016.05.002. Epub 2016 May 13.
- 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. This study is not recruiting at the moment.
Barbara Lawrenz, PhD principal investigator
IVI Middle East Fertility Clinic 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 Endometrial Disorder and Infertility, Female, 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 4 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: stopped early, as of the sponsor's last update on 8 Mar 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 was stopped early (reason given: Investigators perogative). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 12 weeks). 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 NCT04454749, which also lists 13 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 Mar 2021.