Infertility, FemaleNCT03798886
Success Rate Natural Cycles Versus Modified Natural Cycles in Frozen Embryos
An observational study of Infertility, Female, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
There has been a recent significant increase in the frozen embryo replacement (FER) cycles due to freeze-all cycles to decrease the risk of ovarian hyperstimulation syndrome. Now a days making frozen embryo transfers (FETs) a viable alternative to fresh embryo transfer Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- natural cycle, modified natural cycle and embryo transfer
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Dec 2019
- 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
- Healthy volunteers accepted
- Adult
Study population: This study will bw carried out as a prospective randomized clinical trial on regular menstruating patients arriving for transfer of frozen embryo to the center in a single IVF center. Results will collected and recorded daily during the study. With 80% power analysis minimum number of patients 0.05% significance level is 240. Study will be designed in 1 year.
Who may be able to join
- Patient who are admitted to the IVF center and who will be transferred to frozen embryos.
- Infertile women under 40 years of age who accepted this study.
- Unexplained infertilite couple.
- All ovulatory patient.
- Male factor.
- Tubal factor.
Who cannot join
- Patients who made intrauterin surgery.
- Over 40 years of age women.
- Patients with preimplantation genetic diagnosis.
- Anovulatory patient.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem MAA University Atakent Hospital
Istanbul, 34457
About this study
Official title: Comparison of Clinical Results of Frozen Embryo Transfer in Natural and Modified Natural Cycles
There has been a recent significant increase in the frozen embryo replacement (FER) cycles due to freeze-all cycles to decrease the risk of ovarian hyperstimulation syndrome. Now a days making frozen embryo transfers (FETs) a viable alternative to fresh embryo transfer
Read the detailed description
There has been a recent significant increase in the frozen embryo replacement (FER) cycles due to freeze-all cycles to decrease the risk of ovarian hyperstimulation syndrome. Now a days making frozen embryo transfers (FETs) a viable alternative to fresh embryo transfer, with reports from observational studies and randomized controlled trials suggesting that:
- The endometrium in stimulated cycles is not optimal for implantation
- Pregnancy rates are increased following FET
- Perinatal outcomes are less affected after FET
- Preimplantation genetic screening We will follow only natural and modified natural cycles patients. Spontaneous ovulation will documented with hormonal and sonographic monitoring. Hormonal monitoring are including estradiol and luteinizing hormone (LH). Sonographic monitoring is including follicule diameter (16-20 mm). At modified natural cycles we will use hCG triggering for ovulation approximately 16-20 mm diameter.
We will compare success rate between natural and modified natural cycles
- Conditions
- Infertility, Female
- Being tested
- natural cycle, modified natural cycle, embryo transfer
- Keywords
- Frozen embryo replacement, IVF success, ovarian stimulation
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natural cycleOther
Also called natural LH surge
When follicle is ready for ovulation, we will use this injection by intra-dermal route
modified natural cycleOther
Also called recombinant hcg
we will use that drug in the natural modified transfer group after embryo transfer
embryo transferOther
Also called frozen embryo transfer
we will do transfer when the endometrium is ready
| Study group | Role | What they receive |
|---|---|---|
| Natural frozen embryo transfer group | In this group all embryos will be frozen when transfer planned sonographic follicle diameter measured. After spontaneous ovulation, embryo transfer will be planned. Luteal phase support will not be used. Receives: Other: natural cycle; Other: modified natural cycle; Other: embryo transfer | |
| modified natural embryo transfer group | In this group all embryos will be frozen when transfer planned sonographic follicle diameter measured. When follicle diameter is 16-17 mm we will apply hCG (recombinant hCG). After ovulation, embryo transfer will be done. Luteal phase support will not be used. Receives: Other: natural cycle; Other: modified natural cycle; Other: embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
birth
live birth
Measured: bigger than 24 weeks pregnancy
Secondary outcomes (3)
pregnancy rate
hcg blood test
Measured: 10th day after embryo transfer
clinical pregnancy rate
positive fetal cardiac activity
Measured: 8 weeks
abortion rate
abortion after visualization of fetal cardiac activity
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 Jan 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Turgut Aydın, Study director, acıbadem university atakent hospitalElif Ganime Aydeniz, Study chair, acıbadem university atakent hospitalEmine Karabük, Study chair, acıbadem university atakent hospitalBurak Yücel, Study chair, Kanuni Sultan SüleymanHospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798886
- Sponsor's protocol ID
- ATADEK-2018/20
- Status last verified
- Mar 2019
- First submitted
- 7 Jan 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We did not decide for this but if they need any information we can support all
Publications
Weissman A, Horowitz E, Ravhon A, Steinfeld Z, Mutzafi R, Golan A, Levran D. Spontaneous ovulation versus HCG triggering for timing natural-cycle frozen-thawed embryo transfer: a randomized study. Reprod Biomed Online. 2011 Oct;23(4):484-9. doi: 10.1016/j.rbmo.2011.06.004. Epub 2011 Jun 15.
PubMed 21840758Groenewoud ER, Cantineau AE, Kollen BJ, Macklon NS, Cohlen BJ. What is the optimal means of preparing the endometrium in frozen-thawed embryo transfer cycles? A systematic review and meta-analysis. Hum Reprod Update. 2013 Sep-Oct;19(5):458-70. doi: 10.1093/humupd/dmt030. Epub 2013 Jul 2.
PubMed 23820515Kupka MS, Ferraretti AP, de Mouzon J, Erb K, D'Hooghe T, Castilla JA, Calhaz-Jorge C, De Geyter C, Goossens V; European IVF-Monitoring Consortium, for the European Society of Human Reproduction and Embryology. Assisted reproductive technology in Europe, 2010: results generated from European registers by ESHREdagger. Hum Reprod. 2014 Oct 10;29(10):2099-113. doi: 10.1093/humrep/deu175. Epub 2014 Jul 27.
PubMed 25069504Fatemi 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 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Results of Frozen Embryo Transfer in Natural and Modified Natural Cycles
- ClinicalTrials.gov ID
- NCT03798886
- Acronym / sponsor ID
- ATADEK-2018/20
- Conditions
- Infertility, Female
- Keywords
- Frozen embryo replacement, IVF success, ovarian stimulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 10 Jan 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.
There has been a recent significant increase in the frozen embryo replacement (FER) cycles due to freeze-all cycles to decrease the risk of ovarian hyperstimulation syndrome. Now a days making frozen embryo transfers (FETs) a viable alternative to fresh embryo transfer
Detailed description
There has been a recent significant increase in the frozen embryo replacement (FER) cycles due to freeze-all cycles to decrease the risk of ovarian hyperstimulation syndrome. Now a days making frozen embryo transfers (FETs) a viable alternative to fresh embryo transfer, with reports from observational studies and randomized controlled trials suggesting that:
- The endometrium in stimulated cycles is not optimal for implantation
- Pregnancy rates are increased following FET
- Perinatal outcomes are less affected after FET
- Preimplantation genetic screening We will follow only natural and modified natural cycles patients. Spontaneous ovulation will documented with hormonal and sonographic monitoring. Hormonal monitoring are including estradiol and luteinizing hormone (LH). Sonographic monitoring is including follicule diameter (16-20 mm). At modified natural cycles we will use hCG triggering for ovulation approximately 16-20 mm diameter.
We will compare success rate between natural and modified natural cycles
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural frozen embryo transfer group | – | Other: natural cycle, Other: modified natural cycle, Other: embryo transferIn this group all embryos will be frozen when transfer planned sonographic follicle diameter measured. After spontaneous ovulation, embryo transfer will be planned. Luteal phase support will not be used. |
| modified natural embryo transfer group | – | Other: natural cycle, Other: modified natural cycle, Other: embryo transferIn this group all embryos will be frozen when transfer planned sonographic follicle diameter measured. When follicle diameter is 16-17 mm we will apply hCG (recombinant hCG). After ovulation, embryo transfer will be done. Luteal phase support will not be used. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will bw carried out as a prospective randomized clinical trial on regular menstruating patients arriving for transfer of frozen embryo to the center in a single IVF center. Results will collected and recorded daily during the study. With 80% power analysis minimum number of patients 0.05% significance level is 240. Study will be designed in 1 year.
Key inclusion criteria (6 listed)
- Patient who are admitted to the IVF center and who will be transferred to frozen embryos.
- Infertile women under 40 years of age who accepted this study.
- Unexplained infertilite couple.
- All ovulatory patient.
- Male factor.
Key exclusion criteria (4 listed)
- Patients who made intrauterin surgery.
- Over 40 years of age women.
- Patients with preimplantation genetic diagnosis.
- Anovulatory patient.
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 |
|---|---|---|
| natural cycleAlso: natural LH surgeWhen follicle is ready for ovulation, we will use this injection by intra-dermal route | Other | Natural frozen embryo transfer group, modified natural embryo transfer group |
| modified natural cycleAlso: recombinant hcgwe will use that drug in the natural modified transfer group after embryo transfer | Other | Natural frozen embryo transfer group, modified natural embryo transfer group |
| embryo transferAlso: frozen embryo transferwe will do transfer when the endometrium is ready | Other | Natural frozen embryo transfer group, modified natural embryo transfer group |
Primary outcome
birth
Time frame: bigger than 24 weeks pregnancy
live birth
3 secondary outcomes
pregnancy rate
Time frame: 10th day after embryo transfer
clinical pregnancy rate
Time frame: 8 weeks
abortion rate
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Background: PubMed 21840758Weissman A, Horowitz E, Ravhon A, Steinfeld Z, Mutzafi R, Golan A, Levran D. Spontaneous ovulation versus HCG triggering for timing natural-cycle frozen-thawed embryo transfer: a randomized study. Reprod Biomed Online. 2011 Oct;23(4):484-9. doi: 10.1016/j.rbmo.2011.06.004. Epub 2011 Jun 15.
- Background: PubMed 23820515Groenewoud ER, Cantineau AE, Kollen BJ, Macklon NS, Cohlen BJ. What is the optimal means of preparing the endometrium in frozen-thawed embryo transfer cycles? A systematic review and meta-analysis. Hum Reprod Update. 2013 Sep-Oct;19(5):458-70. doi: 10.1093/humupd/dmt030. Epub 2013 Jul 2.
- Results publication: PubMed 25069504Kupka MS, Ferraretti AP, de Mouzon J, Erb K, D'Hooghe T, Castilla JA, Calhaz-Jorge C, De Geyter C, Goossens V; European IVF-Monitoring Consortium, for the European Society of Human Reproduction and Embryology. Assisted reproductive technology in Europe, 2010: results generated from European registers by ESHREdagger. Hum Reprod. 2014 Oct 10;29(10):2099-113. doi: 10.1093/humrep/deu175. Epub 2014 Jul 27.
- 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: Undecided. We did not decide for this but if they need any information we can support all
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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.
Turgut Aydın study director
acıbadem university atakent hospital
Elif Ganime Aydeniz study chair
acıbadem university atakent hospital
Emine Karabük study chair
acıbadem university atakent hospital
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, Female, run by Acibadem University at 1 site in Turkey (Türkiye).
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 6 inclusion and 4 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 13 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 Turkey (Türkiye). 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?
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?
birth (time frame: bigger than 24 weeks pregnancy). 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 NCT03798886, which also lists 4 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 13 Mar 2019.