Uterine Peristaltic Frequencies Between Pregnant and Non-pregnant Women in Embryo Transfer CyclesNCT03587246
Comparison of Uterine Peristaltic Wave Frequencies Between Pregnant and Non-pregnant Women in Embryo Transfer Cycles
An observational study of Uterine Peristaltic Frequencies Between Pregnant and Non-pregnant Women in Embryo Transfer Cycles, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Eligibility criteria Infertile woemn undergo IVF \& embryo transfer cycles at infertility clinic at King Chulalongkorn Memorial Hospital Measurement Uterine peristaltic wave frequencies \& Junctional zone thickness by 3D-TVUS on the day of oocyte retrieval in fresh embryo transfer participants \& day before… Read more about this study
- Who is it for?
- Ages Up to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Peristaltic Frequencies Between Pregnant and Non-pregnant Women in Embryo Transfer Cycles
- What is being tested?
- 3DTVUS : Uterine peristaltic frequencies
- How many people
- 184 participants
- Where
- 1 siteThailand
- Study dates
- 26 Jul 2018to 30 Dec 2018
- 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 Up to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Infertile women undergone IVF cycle treatments and embryo transfer cycles in infertile clinic at King Chulalongkorn Memorial hospital from 2018-2019
Who may be able to join
- women age < 45years
- BMI < 35 kg/m2
- at least one of good quality embryo in embryo transfer cycle by Istanbul consensus workshop morphologic grading Day3 : Grade 1-2, Day4 : Grade 1-2 , Day5 : stage of development grade 2-4
Who cannot join
- structural intrauterine cavity distortion
- leiomyoma FIGO subclassification 3
- adenomyosis
- recurrent pregnancy loss
- recurrent implantation failure
- urerine relaxant drugs
- difficult embryo transfer
Trial locations and contacts
1 site in 1 country.
About this study
Eligibility criteria
- Infertile woemn undergo IVF \& embryo transfer cycles at infertility clinic at King Chulalongkorn Memorial Hospital Measurement
- Uterine peristaltic wave frequencies \& Junctional zone thickness by 3D-TVUS on the day of oocyte retrieval in fresh embryo transfer participants \& day before progesterone supplementation in frozen-thawed embryo transfer participants
- Serum progesterone \& estradiol level in the same day
Read the detailed description
The patients who were planning to undergo fresh embryo transfer cycles used GnRH antogonist protocol. Ovarian stimulation was initiated on the menstrual cycle day 3 with use of daily subcutaneous injection of gonodotrophin; human menopausal gonadotrophin (Menopur®), recombinant FSH-alpha (Gonal-F®), recombinant FSH-beta (Puregon®). After 5 days of stimulation, the dosage of gonadotrophin was adjusted based on ovarian response, as assessed by follicular size monitoring and serum estradiol levels. To prevent premature LH surges, ganirelix (Orgalutran®) was administered by subcutaneous injection when at least one follicle reached a diameter of 13 mm. When the leading follicle reached 18 mm in diameter, final oocyte maturation was triggered by subcutaneous injection of recombinant hCG (Ovidrel®) 0.25 mg or double triggered by addition subcutaneous injection of triptorelin (Diphereline®) 0.1 mg. Oocyte retrieval was performed 36 hours after drug administration. Insemination of retrieved oocytes was performed by intracytoplasmic sperm injection (ICSI). Progesterone supplement was started on the day of ovum pickup with 400 mg-micronized vaginal progesterone pessary (Cyclogest®) two times a day. Embryo transfer was performed on day 4 to day 6 of progesterone supplement.
The patients who were planning to undergo frozen embryo transfer cycles used artificial endometrial preparation or natural cycles. Endometrial priming was achieved with daily oral estradiol valerate (Progynova®) 6-8 mg per day beginning on the
cycle day 3 for 12 days. Endometrial thickness was assessed by transvaginal ultrasonography. Once the endometrium thickness reaches 8 mm with trilaminar appearance, 400-mg micronized vaginal progesterone pessary was started daily. Embryo transfer was performed on day 4 to day 6 of progesterone supplement. In the participants were not achieved the goal, dosage of oral estradiol valerate was increased and/or 50 microgram-transdermal estradiol hemihydrates (Climara®) was added. Two to three days after adjusted dose, the endometrial thickness was reassessed and progesterone was administered as mentioned above if the goal was reached. Cycle cancellation was chosen if the thickness was not optimal.
Embryo transfer was performed following ASRM guidance using either soft or metallic catheter. The procedure was done gently avoiding fundal contact with transabdominal ultrasonography monitoring.
All participants were examined uterine peristaltic wave frequencies and thickness of junctional zone two times by three- dimensional transvaginal ultrasonography (3D-TVUS). The first measurement was performed on day 2 of menstrual cycle. The second measurement was performed on the day planning to start progesterone administration in frozen-thawed embryo transfer protocol and the day of oocyte retrieval in fresh embryo transfer protocol.
Three-dimensional ultrasonography machine, Voluson S6 (GE, USA), was used with RIC5-9W real-time 4D micro-convex endovaginal curved linear probe by single operator. All participants were instructed to avoid sexual activity before evaluation for two days. The patient was lying relaxed in a lithotomy position after emptying the bladder. To avoid stimulating the cervix, the probe was gently introduced into the vagina and uterine peristaltic wave was measured first. Two-minute video of fixed mid-sagittal plane of uterus was recorded. Three dimensional sonographic features were obtained by applying volume box covered the mid-sagittal plane of uterus. Coronal plane of uterus was appeared after automatic sweep of mechanical transducer by multiplanar and OMNI view. Speckle reduction imaging (SRI) and volume contrast imaging (VCI) modality was set up at SRI 0-2 and VCI 2-4 mm. Thickness of junctional zone was measured as the distance from the basal endometrium to the internal layer of the outer myometrium, which appeared as relative hypoechoic linear lining around the endometrium. All sides of uterine wall were evaluated; fundal, lateral, anterior, and posterior wall. Each side was measured at two regions, the thickest and the thinnest distance and the average thickness of each wall was obtained by dividing of the sum of thickest and thinnest area. Finally, the average thickness of four uterine walls was obtained. Uterine peristaltic wave frequencies were analyzed with 4X of regular speed using a VLC media player by two independent observers. The mean of
peristaltic wave frequencies between two persons were obtained if the frequencies were not concordance.
Hormonal levels were checked for analysis two times in each patient. First measurement, serum luteinizing hormone (LH) and estradiol hormone levels were measured at day 2 of menstrual cycle in all participants. The patients in fresh embryo transfer cycles, serum follicle stimulating hormone (FSH) measurement was added. Second measurement, serum estradiol and progesterone hormone levels were checked in the same day of 3D-TVUS assessment.
Two weeks after embryo transfer, serum beta-hCG was first measured. In the patients with rising hCG level, serum level was reassessed at week 3 and week 4 after embryo transfer and transvaginal ultrasonography was performed at week 4 after the transfer. Vaginal progesterone was continued in the same dose and intramuscular 17-hydroxyprogesterone caproate (Depot- proluton®) was added weekly. Luteal support was continued until 12 weeks of gestation. In non-pregnant women, vaginal progesterone was stopped after first measurement of serum beta-hCG. Clinical pregnancy was defined as the presence of intrauterine gestational sac four weeks after embryo transfer.
- Conditions
- Uterine Peristaltic Frequencies Between Pregnant and Non-pregnant Women in Embryo Transfer Cycles
- Being tested
- 3DTVUS : Uterine peristaltic frequencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3DTVUS : Uterine peristaltic frequenciesDiagnostic test
Perform three-dimensional transvaginal ultrasonography To observe uterine peristaltic frequencies in embryo transfer cycles
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Not described Receives: Diagnostic Test: 3DTVUS : Uterine peristaltic frequencies | |
| non-pregnant women | Not described Receives: Diagnostic Test: 3DTVUS : Uterine peristaltic frequencies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of uterine peristaltic frequencies with pregnancy outcomes of embryo transfer cycles
For frozen-thawed embryo cycles : observation on the day of 8 mm-triple layer endometrial thickness For fresh embryo transfer cycles : observation on the day of oocyte retrieval procedure
Measured: 3 minutes
Secondary outcomes (3)
Association of junctional zone thickness with pregnancy outcomes in embryo transfer cycles
For frozen-thawed embryo cycles : observation on the day of 8 mm-triple layer endometrial thickness For fresh embryo transfer cycles : observation on the day of oocyte retrieval procedure
Measured: 3 minutes
Association of uterine peristaltic frequencies and junctional zone thickness between fresh embryo transfer cycles & frozen-thawed embryo transfer cycles
For frozen-thawed embryo cycles : observation on the day of 8 mm-triple layer endometrial thickness For fresh embryo transfer cycles : observation on the day of oocyte retrieval procedure
Measured: 3 minutes
Association of uterine peristaltic frequencies with junctional zone thickness
For frozen-thawed embryo cycles : observation on the day of 8 mm-triple layer endometrial thickness For fresh embryo transfer cycles : observation on the day of oocyte retrieval procedure
Measured: 3minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start26 Jul 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Peristaltic Frequencies Between Pregnant and Non-pregnant Women in Embryo Transfer CyclesStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamolrat Daoudom, Chulalongkorn University
- Investigators
- KamolratD Daoudom, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587246
- Sponsor's protocol ID
- 375/61
- Status last verified
- Mar 2019
- First submitted
- 2 Jul 2018
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Uterine Peristaltic Wave Frequencies Between Pregnant and Non-pregnant Women in Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT03587246
- Acronym / sponsor ID
- 375/61
- Conditions
- Uterine Peristaltic Frequencies Between Pregnant and Non-pregnant Women in Embryo Transfer Cycles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 16 Jul 2018 (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.
Eligibility criteria
- Infertile woemn undergo IVF \& embryo transfer cycles at infertility clinic at King Chulalongkorn Memorial Hospital Measurement
- Uterine peristaltic wave frequencies \& Junctional zone thickness by 3D-TVUS on the day of oocyte retrieval in fresh embryo transfer participants \& day before progesterone supplementation in frozen-thawed embryo transfer participants
- Serum progesterone \& estradiol level in the same day
Detailed description
The patients who were planning to undergo fresh embryo transfer cycles used GnRH antogonist protocol. Ovarian stimulation was initiated on the menstrual cycle day 3 with use of daily subcutaneous injection of gonodotrophin; human menopausal gonadotrophin (Menopur®), recombinant FSH-alpha (Gonal-F®), recombinant FSH-beta (Puregon®). After 5 days of stimulation, the dosage of gonadotrophin was adjusted based on ovarian response, as assessed by follicular size monitoring and serum estradiol levels. To prevent premature LH surges, ganirelix (Orgalutran®) was administered by subcutaneous injection when at least one follicle reached a diameter of 13 mm. When the leading follicle reached 18 mm in diameter, final oocyte maturation was triggered by subcutaneous injection of recombinant hCG (Ovidrel®) 0.25 mg or double triggered by addition subcutaneous injection of triptorelin (Diphereline®) 0.1 mg. Oocyte retrieval was performed 36 hours after drug administration. Insemination of retrieved oocytes was performed by intracytoplasmic sperm injection (ICSI). Progesterone supplement was started on the day of ovum pickup with 400 mg-micronized vaginal progesterone pessary (Cyclogest®) two times a day. Embryo transfer was performed on day 4 to day 6 of progesterone supplement.
The patients who were planning to undergo frozen embryo transfer cycles used artificial endometrial preparation or natural cycles. Endometrial priming was achieved with daily oral estradiol valerate (Progynova®) 6-8 mg per day beginning on the
cycle day 3 for 12 days. Endometrial thickness was assessed by transvaginal ultrasonography. Once the endometrium thickness reaches 8 mm with trilaminar appearance, 400-mg micronized vaginal progesterone pessary was started daily. Embryo transfer was performed on day 4 to day 6 of progesterone supplement. In the participants were not achieved the goal, dosage of oral estradiol valerate was increased and/or 50 microgram-transdermal estradiol hemihydrates (Climara®) was added. Two to three days after adjusted dose, the endometrial thickness was reassessed and progesterone was administered as mentioned above if the goal was reached. Cycle cancellation was chosen if the thickness was not optimal.
Embryo transfer was performed following ASRM guidance using either soft or metallic catheter. The procedure was done gently avoiding fundal contact with transabdominal ultrasonography monitoring.
All participants were examined uterine peristaltic wave frequencies and thickness of junctional zone two times by three- dimensional transvaginal ultrasonography (3D-TVUS). The first measurement was performed on day 2 of menstrual cycle. The second measurement was performed on the day planning to start progesterone administration in frozen-thawed embryo transfer protocol and the day of oocyte retrieval in fresh embryo transfer protocol.
Three-dimensional ultrasonography machine, Voluson S6 (GE, USA), was used with RIC5-9W real-time 4D micro-convex endovaginal curved linear probe by single operator. All participants were instructed to avoid sexual activity before evaluation for two days. The patient was lying relaxed in a lithotomy position after emptying the bladder. To avoid stimulating the cervix, the probe was gently introduced into the vagina and uterine peristaltic wave was measured first. Two-minute video of fixed mid-sagittal plane of uterus was recorded. Three dimensional sonographic features were obtained by applying volume box covered the mid-sagittal plane of uterus. Coronal plane of uterus was appeared after automatic sweep of mechanical transducer by multiplanar and OMNI view. Speckle reduction imaging (SRI) and volume contrast imaging (VCI) modality was set up at SRI 0-2 and VCI 2-4 mm. Thickness of junctional zone was measured as the distance from the basal endometrium to the internal layer of the outer myometrium, which appeared as relative hypoechoic linear lining around the endometrium. All sides of uterine wall were evaluated; fundal, lateral, anterior, and posterior wall. Each side was measured at two regions, the thickest and the thinnest distance and the average thickness of each wall was obtained by dividing of the sum of thickest and thinnest area. Finally, the average thickness of four uterine walls was obtained. Uterine peristaltic wave frequencies were analyzed with 4X of regular speed using a VLC media player by two independent observers. The mean of
peristaltic wave frequencies between two persons were obtained if the frequencies were not concordance.
Hormonal levels were checked for analysis two times in each patient. First measurement, serum luteinizing hormone (LH) and estradiol hormone levels were measured at day 2 of menstrual cycle in all participants. The patients in fresh embryo transfer cycles, serum follicle stimulating hormone (FSH) measurement was added. Second measurement, serum estradiol and progesterone hormone levels were checked in the same day of 3D-TVUS assessment.
Two weeks after embryo transfer, serum beta-hCG was first measured. In the patients with rising hCG level, serum level was reassessed at week 3 and week 4 after embryo transfer and transvaginal ultrasonography was performed at week 4 after the transfer. Vaginal progesterone was continued in the same dose and intramuscular 17-hydroxyprogesterone caproate (Depot- proluton®) was added weekly. Luteal support was continued until 12 weeks of gestation. In non-pregnant women, vaginal progesterone was stopped after first measurement of serum beta-hCG. Clinical pregnancy was defined as the presence of intrauterine gestational sac four weeks after embryo transfer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Diagnostic Test: 3DTVUS : Uterine peristaltic frequencies |
| non-pregnant women | – | Diagnostic Test: 3DTVUS : Uterine peristaltic frequencies |
Who may qualify
- Ages
- Up to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Infertile women undergone IVF cycle treatments and embryo transfer cycles in infertile clinic at King Chulalongkorn Memorial hospital from 2018-2019
Key inclusion criteria (3 listed)
- women age < 45years
- BMI < 35 kg/m2
- at least one of good quality embryo in embryo transfer cycle by Istanbul consensus workshop morphologic grading Day3 : Grade 1-2, Day4 : Grade 1-2 , Day5 : stage of development grade 2-4
Key exclusion criteria (7 listed)
- structural intrauterine cavity distortion
- leiomyoma FIGO subclassification 3
- adenomyosis
- recurrent pregnancy loss
- recurrent implantation failure
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 |
|---|---|---|
| 3DTVUS : Uterine peristaltic frequenciesPerform three-dimensional transvaginal ultrasonography To observe uterine peristaltic frequencies in embryo transfer cycles | Diagnostic test | Pregnant women, non-pregnant women |
Primary outcome
Association of uterine peristaltic frequencies with pregnancy outcomes of embryo transfer cycles
Time frame: 3 minutes
For frozen-thawed embryo cycles : observation on the day of 8 mm-triple layer endometrial thickness For fresh embryo transfer cycles : observation on the day of oocyte retrieval procedure
3 secondary outcomes
Association of junctional zone thickness with pregnancy outcomes in embryo transfer cycles
Time frame: 3 minutes
Association of uterine peristaltic frequencies and junctional zone thickness between fresh embryo transfer cycles & frozen-thawed embryo transfer cycles
Time frame: 3 minutes
Association of uterine peristaltic frequencies with junctional zone thickness
Time frame: 3minutes
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 21 Mar 2019.
- Individual participant dataSharing planned: No
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.
KamolratD Daoudom, MD principal investigator
Chulalongkorn University
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 Uterine Peristaltic Frequencies Between Pregnant and Non-pregnant Women in Embryo Transfer Cycles, run by Chulalongkorn University at 1 site in Thailand.
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 7 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 21 Mar 2019. 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 Thailand. 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?
Association of uterine peristaltic frequencies with pregnancy outcomes of embryo transfer cycles (time frame: 3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.