InfertilityNCT02420704
Effect of Endometrial Thickness on IVF Outcome
An observational study of Infertility, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
Although many studies have evaluated the relationship between endometrial thickness and IVF outcome, the results are still controversial. We notice that, during our daily work, for patients undergoing cleavage stage embryo transfer, endometrial thickness seems to have a huge impact on IVF outcome; however, for… Read more about this study
- Who is it for?
- Ages 22 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Embryo transfer
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Dec 2015
- 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 22 to 38 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients transfrred with at least two high quality cleavage stage embryos, or with at least one high quality blastocyst stage embryo.
Who may be able to join
- age between 22-38 years old;
- the first cycle of IVF treatment with standard long protocol;
- transfrred with at least two high quality cleavage stage embryos, or with at least one high quality blastocyst stage embryo.
Who cannot join
- PGD cycles;
- gamete donation cycles
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Yingpu Ms Sun, M.D,PhD, 86-13803841888, syp2008@vip.sina.com
Zhiqin Mr Bu, MD, 86-15981978863, rmczzu@126.com
About this study
Official title: Effect of Endometrial Thickness on IVF Outcome: a Prospective Observational Study of Both Cleavage Stage and Blastocyst Stage Embryo Transfer Cycles
Although many studies have evaluated the relationship between endometrial thickness and IVF outcome, the results are still controversial. We notice that, during our daily work, for patients undergoing cleavage stage embryo transfer, endometrial thickness seems to have a huge impact on IVF outcome; however, for blastocyst stage embryo transfers, IVF outcome seems to have little association with endometrial thickness. Thus, the aim of this prospective observational study is to explore the relationship between endometrial thickness and IVF outcome in patients undergoing cleavage stage and blastocyst stage embryo transfers, respectively.
- Conditions
- Infertility
- Being tested
- Embryo transfer
- Keywords
- IVF, endometrial thickness, cleavage stage embryo, blastocyst stage embryo, Ongoing pregnancy rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embryo transferProcedure or surgery
For fresh cycles, embryos were transferred 3-5 days after oocyte retrieval; For frozen thawed cycles, embryos were transferred 3-5 days after starting to use progesterone based on the stage of cryopreservation.
| Study group | Role | What they receive |
|---|---|---|
| Cleavage stage-thin endometrial | Patients transferred with cleavage stage embryo, with endometrial thickness ≤7mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles. Receives: Procedure: Embryo transfer | |
| Cleavage stage-medium endometrial | Patients transferred with cleavage stage embryo, with endometrial thickness 8-13mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles. Receives: Procedure: Embryo transfer | |
| Cleavage stage-thick endometrial | Patients transferred with cleavage stage embryo, with endometrial thickness ≥14mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles. Receives: Procedure: Embryo transfer | |
| Blastocyst stage-thin endometrial | Patients transferred with blastocyst stage embryo, with endometrial thickness ≤7mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles. Receives: Procedure: Embryo transfer | |
| Blastocyst stage-medium endometrial | Patients transferred with blastocyst stage embryo, with endometrial thickness 8-13mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles. Receives: Procedure: Embryo transfer | |
| Blastocyst stage-thick endometrial | Patients transferred with blastocyst stage embryo, with endometrial thickness ≥14mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles. Receives: Procedure: Embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
An ongoing pregnancy was defined as a pregnancy with a positive heartbeat by ultrasound after 12 weeks gestation.
Measured: 12 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startNov 2014
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou 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
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingpu Sun, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Yingpu Sun, M.D, Principal investigator, Reproductive Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420704
- Sponsor's protocol ID
- RMCZZU-Endometrial thickness
- Status last verified
- Apr 2015
- First submitted
- 15 Apr 2015
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu Y, Gao X, Lu X, Xi J, Jiang S, Sun Y, Xi X. Endometrial thickness affects the outcome of in vitro fertilization and embryo transfer in normal responders after GnRH antagonist administration. Reprod Biol Endocrinol. 2014 Oct 9;12:96. doi: 10.1186/1477-7827-12-96.
PubMed 25296555Zhao 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 25070912Kasius 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 24664156
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endometrial Thickness on IVF Outcome: a Prospective Observational Study of Both Cleavage Stage and Blastocyst Stage Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT02420704
- Acronym / sponsor ID
- RMCZZU-Endometrial thickness
- Conditions
- Infertility
- Keywords
- IVF, endometrial thickness, cleavage stage embryo, blastocyst stage embryo, Ongoing pregnancy rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 20 Apr 2015 (estimated)
- 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.
Although many studies have evaluated the relationship between endometrial thickness and IVF outcome, the results are still controversial. We notice that, during our daily work, for patients undergoing cleavage stage embryo transfer, endometrial thickness seems to have a huge impact on IVF outcome; however, for blastocyst stage embryo transfers, IVF outcome seems to have little association with endometrial thickness. Thus, the aim of this prospective observational study is to explore the relationship between endometrial thickness and IVF outcome in patients undergoing cleavage stage and blastocyst stage embryo transfers, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cleavage stage-thin endometrial | – | Procedure: Embryo transferPatients transferred with cleavage stage embryo, with endometrial thickness ≤7mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles. |
| Cleavage stage-medium endometrial | – | Procedure: Embryo transferPatients transferred with cleavage stage embryo, with endometrial thickness 8-13mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles. |
| Cleavage stage-thick endometrial | – | Procedure: Embryo transferPatients transferred with cleavage stage embryo, with endometrial thickness ≥14mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles. |
| Blastocyst stage-thin endometrial | – | Procedure: Embryo transferPatients transferred with blastocyst stage embryo, with endometrial thickness ≤7mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles. |
| Blastocyst stage-medium endometrial | – | Procedure: Embryo transferPatients transferred with blastocyst stage embryo, with endometrial thickness 8-13mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles. |
| Blastocyst stage-thick endometrial | – | Procedure: Embryo transferPatients transferred with blastocyst stage embryo, with endometrial thickness ≥14mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles. |
Who may qualify
- Ages
- 22 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients transfrred with at least two high quality cleavage stage embryos, or with at least one high quality blastocyst stage embryo.
Key inclusion criteria (3 listed)
- age between 22-38 years old;
- the first cycle of IVF treatment with standard long protocol;
- transfrred with at least two high quality cleavage stage embryos, or with at least one high quality blastocyst stage embryo.
Key exclusion criteria (2 listed)
- PGD cycles;
- gamete donation cycles
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 |
|---|---|---|
| Embryo transferFor fresh cycles, embryos were transferred 3-5 days after oocyte retrieval; For frozen thawed cycles, embryos were transferred 3-5 days after starting to use progesterone based on the stage of cryopreservation. | Procedure or surgery | Blastocyst stage-medium endometrial, Blastocyst stage-thick endometrial, Blastocyst stage-thin endometrial, Cleavage stage-medium endometrial, Cleavage stage-thick endometrial, Cleavage stage-thin endometrial |
Primary outcome
Ongoing pregnancy rate
Time frame: 12 weeks after embryo transfer
An ongoing pregnancy was defined as a pregnancy with a positive heartbeat by ultrasound after 12 weeks gestation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
- Background: PubMed 25296555Wu Y, Gao X, Lu X, Xi J, Jiang S, Sun Y, Xi X. Endometrial thickness affects the outcome of in vitro fertilization and embryo transfer in normal responders after GnRH antagonist administration. Reprod Biol Endocrinol. 2014 Oct 9;12:96. doi: 10.1186/1477-7827-12-96.
- Background: PubMed 25070912Zhao 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.
- Background: 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.
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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.
Yingpu Sun, M.D principal investigator
Reproductive Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 21 Apr 2015. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiqin Bu, M.D (86-15981978863, rmczzu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 12 weeks after embryo transfer). 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 NCT02420704, which also lists 3 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 21 Apr 2015.