Embryo TransferNCT03581422
Natural Cycles With Spontaneous Versus Induced Ovulation in FET
An observational study of Embryo Transfer, run by Istituto Clinico Humanitas.
Trial summary
In recent years, frozen-thawed embryo transfer procedure (FET) has been widely used to increase the cumulative pregnancy rate per IVF-cycle: which is the best preparation protocol remains a matter of debate. A retrospective analysis was conducted between 2012-2017. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Embryo Transfer
- What is being tested?
- hCG administration before embryo transfer
- How many people
- 2,866 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2017
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: 2866 cycles were included in the analysis. To limit potential confounders, only single blastocyst transfer cycles were included, vitrified on Days 5 or 6, excluding PGT-a cycles and cleavage stage embryo transfers.
Who may be able to join
- only single blastocyst transfer cycles were included
Who cannot join
- PGT-a cycles and cleavage stage embryo transfers
About this study
Official title: Frozen-Thawed Embryo Transfers: a Comparison Between Natural Cycles With Spontaneous or Induced Ovulation
In recent years, frozen-thawed embryo transfer procedure (FET) has been widely used to increase the cumulative pregnancy rate per IVF-cycle: which is the best preparation protocol remains a matter of debate.
A retrospective analysis was conducted between 2012-2017. The aim was comparing clinical pregnancy rate (CPR) of pure natural cycle frozen-thawed embryo transfer (NC-FET) versus natural cycle frozen-thawed embryo transfer with hCG-triggered ovulation (mNC-FET).
Read the detailed description
Compared to repeated oocyte retrieval procedure, frozen-thawed embryo transfer (FET) has been widely used to increase the cumulative pregnancy rate per IVF-cycle, with demonstrated superiority in preventing ovarian hyperstimulation syndrome and improving cost-efficiency and time to pregnancy.
It is controversial whether triggering ovulation of the dominant follicle using human chorionic gonadotrophin (hCG) may benefit or reduce embryo implantation, when compared with a natural cycle environment. Unfavourable clinical outcomes of controlled ovarian stimulation have been reported by recently published studies, compared to the spontaneous LH surge.
This study aimed to compare the effectiveness in terms of better clinical pregnancy rates (CPR) of pure natural cycle frozen-thawed embryo transfer (NC-FET) versus natural cycle frozen-thawed embryo transfer modified by HCG administration\with hCG-triggered ovulation (mNC-FET).
A retrospective analysis was conducted between 2012-2017. In patients with regular ovulatory cycles, the timing of embryo thawing and transferring was based on spontaneous LH surge (NC-FET). Patients attended for ultrasound evaluation of the dominant follicle from Day 8 to 10 of their menstrual cycle (depending on cycle length), detecting luteinizing hormone (LH) surge in urine/ taking an ovulation test for urinary LH measurement. In selected cases, a serum assays of LH, progesterone and estradioI has been further obtained. When the endometrial thickness reached 8 mm and dominant follicle 16-20 mm in diameter, hCG was administered in absence of urinary LH surge. Embryo thawing and transfer was planned 7 days after LH surge or HCG administration, whether G5 or G6 blastocyst. Exogenous progesterone supplementation started 2 days after hCG administration versus the same day of embryo transfer procedure in NC- ET. To limit potential confounders, only single blastocyst transfer cycles were included, vitrified on Days 5 or 6, excluding PGT-a (Pre Gestational Test for aneuploydia) cycles and cleavage stage embryo transfers. A unilevel and multi level logistic regression analysis was conducted using Stata Software versione15.
- Conditions
- Embryo Transfer
- Being tested
- hCG administration before embryo transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hCG administration before embryo transferDrug
Also called Gonasi HP 5000 UI or Ovitrelle 250mg
Thawed embryo transfer with ovulation triggered by hCG
| Study group | Role | What they receive |
|---|---|---|
| NC-FET | pure natural cycle frozen-thawed embryo transfer | |
| mNC-FET | modified natural cycle frozen-thawed embryo transfer by hCG administration Receives: Drug: hCG administration before embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPR in NCFET vs mNCFET
compare the effectiveness in terms of better clinical pregnancy rates (CPR) of pure natural cycle frozen-thawed embryo transfer (NC-FET) versus natural cycle frozen-thawed embryo transfer modified by HCG administration
Measured: 2012-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start1 Jan 2012
- Primary completion15 Jun 2015
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Embryo TransferStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,866 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581422
- Sponsor's protocol ID
- xxxx2018
- Status last verified
- Jun 2018
- First submitted
- 26 Jun 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levi Setti PE, Cirillo F, De Cesare R, Morenghi E, Canevisio V, Ronchetti C, Baggiani A, Smeraldi A, Albani E, Patrizio P. Seven Years of Vitrified Blastocyst Transfers: Comparison of 3 Preparation Protocols at a Single ART Center. Front Endocrinol (Lausanne). 2020 May 29;11:346. doi: 10.3389/fendo.2020.00346. eCollection 2020.
PubMed 32547496
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frozen-Thawed Embryo Transfers: a Comparison Between Natural Cycles With Spontaneous or Induced Ovulation
- ClinicalTrials.gov ID
- NCT03581422
- Acronym / sponsor ID
- xxxx2018
- Conditions
- Embryo Transfer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,866 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 15 Jun 2015 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 10 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.
In recent years, frozen-thawed embryo transfer procedure (FET) has been widely used to increase the cumulative pregnancy rate per IVF-cycle: which is the best preparation protocol remains a matter of debate.
A retrospective analysis was conducted between 2012-2017. The aim was comparing clinical pregnancy rate (CPR) of pure natural cycle frozen-thawed embryo transfer (NC-FET) versus natural cycle frozen-thawed embryo transfer with hCG-triggered ovulation (mNC-FET).
Detailed description
Compared to repeated oocyte retrieval procedure, frozen-thawed embryo transfer (FET) has been widely used to increase the cumulative pregnancy rate per IVF-cycle, with demonstrated superiority in preventing ovarian hyperstimulation syndrome and improving cost-efficiency and time to pregnancy.
It is controversial whether triggering ovulation of the dominant follicle using human chorionic gonadotrophin (hCG) may benefit or reduce embryo implantation, when compared with a natural cycle environment. Unfavourable clinical outcomes of controlled ovarian stimulation have been reported by recently published studies, compared to the spontaneous LH surge.
This study aimed to compare the effectiveness in terms of better clinical pregnancy rates (CPR) of pure natural cycle frozen-thawed embryo transfer (NC-FET) versus natural cycle frozen-thawed embryo transfer modified by HCG administration\with hCG-triggered ovulation (mNC-FET).
A retrospective analysis was conducted between 2012-2017. In patients with regular ovulatory cycles, the timing of embryo thawing and transferring was based on spontaneous LH surge (NC-FET). Patients attended for ultrasound evaluation of the dominant follicle from Day 8 to 10 of their menstrual cycle (depending on cycle length), detecting luteinizing hormone (LH) surge in urine/ taking an ovulation test for urinary LH measurement. In selected cases, a serum assays of LH, progesterone and estradioI has been further obtained. When the endometrial thickness reached 8 mm and dominant follicle 16-20 mm in diameter, hCG was administered in absence of urinary LH surge. Embryo thawing and transfer was planned 7 days after LH surge or HCG administration, whether G5 or G6 blastocyst. Exogenous progesterone supplementation started 2 days after hCG administration versus the same day of embryo transfer procedure in NC- ET. To limit potential confounders, only single blastocyst transfer cycles were included, vitrified on Days 5 or 6, excluding PGT-a (Pre Gestational Test for aneuploydia) cycles and cleavage stage embryo transfers. A unilevel and multi level logistic regression analysis was conducted using Stata Software versione15.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NC-FET | – | –pure natural cycle frozen-thawed embryo transfer |
| mNC-FET | – | Drug: hCG administration before embryo transfermodified natural cycle frozen-thawed embryo transfer by hCG administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 2866 cycles were included in the analysis. To limit potential confounders, only single blastocyst transfer cycles were included, vitrified on Days 5 or 6, excluding PGT-a cycles and cleavage stage embryo transfers.
Key inclusion criteria (1 listed)
- only single blastocyst transfer cycles were included
Key exclusion criteria (1 listed)
- PGT-a cycles and cleavage stage embryo transfers
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 |
|---|---|---|
| hCG administration before embryo transferAlso: Gonasi HP 5000 UI or Ovitrelle 250mgThawed embryo transfer with ovulation triggered by hCG | Drug | mNC-FET |
Primary outcome
CPR in NCFET vs mNCFET
Time frame: 2012-2017
compare the effectiveness in terms of better clinical pregnancy rates (CPR) of pure natural cycle frozen-thawed embryo transfer (NC-FET) versus natural cycle frozen-thawed embryo transfer modified by HCG administration
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 19 Jul 2018.
- Derived from this study: PubMed 32547496Levi Setti PE, Cirillo F, De Cesare R, Morenghi E, Canevisio V, Ronchetti C, Baggiani A, Smeraldi A, Albani E, Patrizio P. Seven Years of Vitrified Blastocyst Transfers: Comparison of 3 Preparation Protocols at a Single ART Center. Front Endocrinol (Lausanne). 2020 May 29;11:346. doi: 10.3389/fendo.2020.00346. eCollection 2020.
- Individual participant dataSharing planned: No
Related trials for Embryo Transfer
Not yet recruiting
Cryopreserved Pre-embryo Transfer in a Cytokine-rich Medium Versus Hyaluronic Acid
Frozen Embryo Transfer (FET)
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
RecruitingPhase 2
Effect of FB301 on Vaginal Bacterial Profile in Women With Asymptomatic Vaginal Dysbiosis Undergoing a Mock Frozen Embryo Transfer Cycle
Vaginal Dysbiosis
RecruitingPhase 2/3
Thymosin-α1 for Recurrent Implantation Failure
Recurrent Implantation Faliure
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Embryo Transfer, run by Istituto Clinico Humanitas.
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 1 inclusion and 1 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 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
CPR in NCFET vs mNCFET (time frame: 2012-2017). 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 NCT03581422, which also lists 1 linked publication.
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 19 Jul 2018.