Embryo TransferPhase 4NCT02825290
Modified Luteal Support for Frozen-Thawed Embryo Transfer - A Prospective Study
A Phase 4 study testing Choriogonadotropin alfa and Triptorelin acetate in people with Embryo Transfer and Luteal Support, run by Sheba Medical Center at 1 site in Israel.
Trial summary
This study evaluates the outcomes of frozen-thawed embryo transfer (FET) success rate with modified luteal support - addition of a single injection of HCG and GnRH-agonist, on day of ET and 4 days later, respectively vs. traditional luteal support with vaginal progesterone only in ovulating women. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Embryo Transfer, Luteal Support
- What is being tested?
- Choriogonadotropin alfa and Triptorelin acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2016to Jun 2017
- Phase
- Phase 4
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-40 years old women
- Spontaneously ovulating women
- Treated in our IVF unit for frozen-thawed embryo transfer
- At least one top quality embryo
Who cannot join
- PGD patients
- More than 4 previous embryo transfers
Trial locations and contacts
1 site in 1 country.
Raoul Orvieto, MD contact
Israel1 site, 1 recruiting
- Recruiting
Sheba medical center
Ramat Gan
Eran Zilberberg, MD, +97235302882
About this study
This study evaluates the outcomes of frozen-thawed embryo transfer (FET) success rate with modified luteal support - addition of a single injection of HCG and GnRH-agonist, on day of ET and 4 days later, respectively vs. traditional luteal support with vaginal progesterone only in ovulating women.
Read the detailed description
Background With the recent trend toward single embryo transfer (ET) adopted in an attempt to reduce the risk of multiple pregnancy, the remaining extra embryos are cryopreserved, providing further possibilities for conception after the initial fresh transfer. Moreover, several studies that compared fresh and frozen-thawed embryo transfer (FET) cycles in normal responders have demonstrated a significantly higher clinical pregnancy rate per transfer in the FET versus the fresh cycles.
There are several currently employed replacement protocols for FET. The choice of protocol depends on the individual woman's ovarian function and convenience of the method, as well as on the experience gained with the method by the physicians. Whatever protocol is used, the success requires optimal synchronization between the embryonic stage at thawing and date of the endometrium within the endometrial preparation cycle. While there is a consensus regarding the duration, route of delivery and dosage of estrogen supplementation, and the optimal ultrasonographic endometrial appearance and thickness, the effect of the different modes of luteal support remains unclear.
Prompted by the study demonstrating higher ongoing pregnancy rate following the transfer of frozen-thawed embryos in natural cycles with spontaneous LH rise compared with natural cycles controlled by hCG for final oocyte maturation and the reports showing improved pregnancy rate in patients who received a mid-luteal injection of a GnRH-agonist (0.1 mg triptorelin), the investigators started beginning at June 2014 to offer ovulatory patients with regular menstrual cycles a natural FET with modified luteal support. Starting on the day of spontaneous ovulation, patients received daily vaginal progesterone, supplemented by a single injection of HCG and GnRH-agonist, on day of ET and 4 days later, respectively.
The results for this study were very promising - the investigators were able to show a significant increase in implantation rate (30% vs. 17%; p<0.03), clinical pregnancy (48% vs. 26%; p<0.01) and ongoing pregnancy (39% vs. 20%; p<0.01) for the patients receiving the aforementioned modified luteal support protocol.
After the completion of this retrospective study the investigators are heading to prove the superiority of the modified luteal support protocol for ovulatory patients by conducting a prospective study.
Materials \& Methods Study design - A prospective, randomized, blinded study. Primary endpoint - Ongoing pregnancy. Secondary endpoints - Implantation rate, clinical pregnancy. Study sample - According to the previous, retrospective study the investigators will need 31 patients in each study arm in order to show an increase from 20% clinical pregnancy to 39% (confidence level 5%, beta error level 50%).
The patients - The investigators will offer each patient treated in the unit for frozen-thawed embryo transfer to participate in the study. The randomization of the participants will be on the day of embryo transfer with a computer program on a 1:1 enrollment ratio.
All transfers will be performed by an experienced physician who will be blinded to the luteal support protocol.
Both groups will be treated with the accepted progesterone luteal support - starting on ovulation day - vaginal progesterone 90 mg (Crinone; Merck Serono, Hellerup, Denmark) once a day.
Study group - Patients in the study group will receive additional two injections - the first - recombinant hCG 250 mcg (Ovitrelle; Merck Serono) on the transfer day and the second - GnRH-agonist 0.1 mg (Decapeptyl; Ferring Pharmaceuticals Israel) 4 days after the embryo transfer day. Patients in the control group will receive no injection.
B-hCG levels will be examined 12 days after embryo transfer and if positive ultrasound examinations will be performed as usual to document pregnancy outcome.
The data - The investigators will use demographic data such as age, BMI, gynecological data as gravida, para, etiology of infertility and data about previous \& current IVF treatments such as number of treatments, stimulation protocol, hormone levels, number of oocytes, embryos' characteristics, etc.
Statistics - Statistical analysis will be performed with Student's t-test and Chi square, as appropriate. Results will be presented as means ± standard deviations; p<0.05 will be considered significant.
- Conditions
- Embryo Transfer, Luteal Support
- Being tested
- Choriogonadotropin alfa, Triptorelin acetate
- Keywords
- Frozen-thawed embryo transfer (FET), Luteal support, Progesterone, Natural cycle, Cryopreservation, IVF, hCG, GnRH-Agonist, Pregnancy rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choriogonadotropin alfaDrug
Also called recombinant hCG, Ovitrelle, Ovidrel
Triptorelin acetateDrug
Also called GnRH-Agonist, Decapeptyl
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | hCG (Choriogonadotropin alfa; Ovitrelle 250 mcg) on day of embryo transfer \& GnRH-agonist (Triptorelin acetate; Decapeptyl 0.1 mg) after 4 days In addition to the usual progesterone luteal support. Receives: Drug: Choriogonadotropin alfa; Drug: Triptorelin acetate |
| Control group | No intervention | The usual progesterone only luteal phase support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy
Number of viable pregnancies at about 10-12 weeks of gestation.
Measured: About 10-12 weeks after embryo transfer
Secondary outcomes (2)
Implantation rate
Positive BhCG blood test
Measured: 2 weeks after embryo transfer
Clinical pregnancy
Visible intrauterine gestational sacs on ultrasound exam
Measured: About 3-4 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 posted7 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
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 Embryo TransferStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Eran Zilberberg, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825290
- Sponsor's protocol ID
- 2537-15-SMC
- Status last verified
- Dec 2016
- First submitted
- 3 Jul 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Thurin A, Hausken J, Hillensjo T, Jablonowska B, Pinborg A, Strandell A, Bergh C. Elective single-embryo transfer versus double-embryo transfer in in vitro fertilization. N Engl J Med. 2004 Dec 2;351(23):2392-402. doi: 10.1056/NEJMoa041032.
PubMed 15575055Le Lannou D, Griveau JF, Laurent MC, Gueho A, Veron E, Morcel K. Contribution of embryo cryopreservation to elective single embryo transfer in IVF-ICSI. Reprod Biomed Online. 2006 Sep;13(3):368-75. doi: 10.1016/s1472-6483(10)61441-1.
PubMed 16984767Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C. Clinical rationale for cryopreservation of entire embryo cohorts in lieu of fresh transfer. Fertil Steril. 2014 Jul;102(1):3-9. doi: 10.1016/j.fertnstert.2014.04.018. Epub 2014 May 17.
PubMed 24842675Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C, Thomas S. Evidence of impaired endometrial receptivity after ovarian stimulation for in vitro fertilization: a prospective randomized trial comparing fresh and frozen-thawed embryo transfer in normal responders. Fertil Steril. 2011 Aug;96(2):344-8. doi: 10.1016/j.fertnstert.2011.05.050. Epub 2011 Jul 6.
PubMed 21737072Orvieto R, Fisch B, Feldberg D. Endometrial Preparation for Patients undergoing Frozen- Thawed Embryo Transfer Cycles. In: The Art & Science of Assisted Reproductive Techniques. G. Allahbadia, R. asuray, R. Merchant, Eds. Jaypee Brothers Medical Publishers (P) Ltd. New Delhi, India, 2003, pp. 396-9.
Navot D, Laufer N, Kopolovic J, Rabinowitz R, Birkenfeld A, Lewin A, Granat M, Margalioth EJ, Schenker JG. Artificially induced endometrial cycles and establishment of pregnancies in the absence of ovaries. N Engl J Med. 1986 Mar 27;314(13):806-11. doi: 10.1056/NEJM198603273141302.
PubMed 3951513Pritts EA, Atwood AK. Luteal phase support in infertility treatment: a meta-analysis of the randomized trials. Hum Reprod. 2002 Sep;17(9):2287-99. doi: 10.1093/humrep/17.9.2287.
PubMed 12202415Meldrum DR. Female reproductive aging--ovarian and uterine factors. Fertil Steril. 1993 Jan;59(1):1-5. doi: 10.1016/s0015-0282(16)55608-8.
PubMed 8419194Fatemi 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 20097333Tesarik J, Hazout A, Mendoza C. Enhancement of embryo developmental potential by a single administration of GnRH agonist at the time of implantation. Hum Reprod. 2004 May;19(5):1176-80. doi: 10.1093/humrep/deh235. Epub 2004 Apr 7.
PubMed 15070873Tesarik J, Hazout A, Mendoza-Tesarik R, Mendoza N, Mendoza C. Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles. Hum Reprod. 2006 Oct;21(10):2572-9. doi: 10.1093/humrep/del173. Epub 2006 Aug 22.
PubMed 16926261Orvieto R, Brengauz M, Feldman B. A novel approach to normal responder patient with repeated implantation failures--a case report. Gynecol Endocrinol. 2015 Jun;31(6):435-7. doi: 10.3109/09513590.2015.1005595. Epub 2015 Mar 3.
PubMed 25731193Haas J, Lantsberg D, Feldman N, Manela D, Machtinger R, Dar S, Rabinovici J, Orvieto R. Modifying the luteal phase support in natural cycle frozen-thawed embryo transfer improves cycle outcome. Gynecol Endocrinol. 2015;31(11):891-3. doi: 10.3109/09513590.2015.1075502. Epub 2015 Aug 18.
PubMed 26288149
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Luteal Support for Frozen-Thawed Embryo Transfer - A Prospective Study
- ClinicalTrials.gov ID
- NCT02825290
- Acronym / sponsor ID
- 2537-15-SMC
- Conditions
- Embryo Transfer, Luteal Support
- Keywords
- Frozen-thawed embryo transfer (FET), Luteal support, Progesterone, Natural cycle, Cryopreservation, IVF, hCG, GnRH-Agonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 7 Jul 2016 (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.
This study evaluates the outcomes of frozen-thawed embryo transfer (FET) success rate with modified luteal support - addition of a single injection of HCG and GnRH-agonist, on day of ET and 4 days later, respectively vs. traditional luteal support with vaginal progesterone only in ovulating women.
Detailed description
Background With the recent trend toward single embryo transfer (ET) adopted in an attempt to reduce the risk of multiple pregnancy, the remaining extra embryos are cryopreserved, providing further possibilities for conception after the initial fresh transfer. Moreover, several studies that compared fresh and frozen-thawed embryo transfer (FET) cycles in normal responders have demonstrated a significantly higher clinical pregnancy rate per transfer in the FET versus the fresh cycles.
There are several currently employed replacement protocols for FET. The choice of protocol depends on the individual woman's ovarian function and convenience of the method, as well as on the experience gained with the method by the physicians. Whatever protocol is used, the success requires optimal synchronization between the embryonic stage at thawing and date of the endometrium within the endometrial preparation cycle. While there is a consensus regarding the duration, route of delivery and dosage of estrogen supplementation, and the optimal ultrasonographic endometrial appearance and thickness, the effect of the different modes of luteal support remains unclear.
Prompted by the study demonstrating higher ongoing pregnancy rate following the transfer of frozen-thawed embryos in natural cycles with spontaneous LH rise compared with natural cycles controlled by hCG for final oocyte maturation and the reports showing improved pregnancy rate in patients who received a mid-luteal injection of a GnRH-agonist (0.1 mg triptorelin), the investigators started beginning at June 2014 to offer ovulatory patients with regular menstrual cycles a natural FET with modified luteal support. Starting on the day of spontaneous ovulation, patients received daily vaginal progesterone, supplemented by a single injection of HCG and GnRH-agonist, on day of ET and 4 days later, respectively.
The results for this study were very promising - the investigators were able to show a significant increase in implantation rate (30% vs. 17%; p<0.03), clinical pregnancy (48% vs. 26%; p<0.01) and ongoing pregnancy (39% vs. 20%; p<0.01) for the patients receiving the aforementioned modified luteal support protocol.
After the completion of this retrospective study the investigators are heading to prove the superiority of the modified luteal support protocol for ovulatory patients by conducting a prospective study.
Materials \& Methods Study design - A prospective, randomized, blinded study. Primary endpoint - Ongoing pregnancy. Secondary endpoints - Implantation rate, clinical pregnancy. Study sample - According to the previous, retrospective study the investigators will need 31 patients in each study arm in order to show an increase from 20% clinical pregnancy to 39% (confidence level 5%, beta error level 50%).
The patients - The investigators will offer each patient treated in the unit for frozen-thawed embryo transfer to participate in the study. The randomization of the participants will be on the day of embryo transfer with a computer program on a 1:1 enrollment ratio.
All transfers will be performed by an experienced physician who will be blinded to the luteal support protocol.
Both groups will be treated with the accepted progesterone luteal support - starting on ovulation day - vaginal progesterone 90 mg (Crinone; Merck Serono, Hellerup, Denmark) once a day.
Study group - Patients in the study group will receive additional two injections - the first - recombinant hCG 250 mcg (Ovitrelle; Merck Serono) on the transfer day and the second - GnRH-agonist 0.1 mg (Decapeptyl; Ferring Pharmaceuticals Israel) 4 days after the embryo transfer day. Patients in the control group will receive no injection.
B-hCG levels will be examined 12 days after embryo transfer and if positive ultrasound examinations will be performed as usual to document pregnancy outcome.
The data - The investigators will use demographic data such as age, BMI, gynecological data as gravida, para, etiology of infertility and data about previous \& current IVF treatments such as number of treatments, stimulation protocol, hormone levels, number of oocytes, embryos' characteristics, etc.
Statistics - Statistical analysis will be performed with Student's t-test and Chi square, as appropriate. Results will be presented as means ± standard deviations; p<0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Choriogonadotropin alfa, Drug: Triptorelin acetatehCG (Choriogonadotropin alfa; Ovitrelle 250 mcg) on day of embryo transfer \& GnRH-agonist (Triptorelin acetate; Decapeptyl 0.1 mg) after 4 days In addition to the usual progesterone luteal support. |
| Control group | No intervention | –The usual progesterone only luteal phase support. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 20-40 years old women
- Spontaneously ovulating women
- Treated in our IVF unit for frozen-thawed embryo transfer
- At least one top quality embryo
Key exclusion criteria (2 listed)
- PGD patients
- More than 4 previous 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 |
|---|---|---|
| Choriogonadotropin alfaAlso: recombinant hCG, Ovitrelle, Ovidrel | Drug | Study group |
| Triptorelin acetateAlso: GnRH-Agonist, Decapeptyl | Drug | Study group |
Primary outcome
Ongoing pregnancy
Time frame: About 10-12 weeks after embryo transfer
Number of viable pregnancies at about 10-12 weeks of gestation.
2 secondary outcomes
Implantation rate
Time frame: 2 weeks after embryo transfer
Clinical pregnancy
Time frame: About 3-4 weeks after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Background: PubMed 15575055Thurin A, Hausken J, Hillensjo T, Jablonowska B, Pinborg A, Strandell A, Bergh C. Elective single-embryo transfer versus double-embryo transfer in in vitro fertilization. N Engl J Med. 2004 Dec 2;351(23):2392-402. doi: 10.1056/NEJMoa041032.
- Background: PubMed 16984767Le Lannou D, Griveau JF, Laurent MC, Gueho A, Veron E, Morcel K. Contribution of embryo cryopreservation to elective single embryo transfer in IVF-ICSI. Reprod Biomed Online. 2006 Sep;13(3):368-75. doi: 10.1016/s1472-6483(10)61441-1.
- Background: PubMed 24842675Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C. Clinical rationale for cryopreservation of entire embryo cohorts in lieu of fresh transfer. Fertil Steril. 2014 Jul;102(1):3-9. doi: 10.1016/j.fertnstert.2014.04.018. Epub 2014 May 17.
- Background: PubMed 21737072Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C, Thomas S. Evidence of impaired endometrial receptivity after ovarian stimulation for in vitro fertilization: a prospective randomized trial comparing fresh and frozen-thawed embryo transfer in normal responders. Fertil Steril. 2011 Aug;96(2):344-8. doi: 10.1016/j.fertnstert.2011.05.050. Epub 2011 Jul 6.
- BackgroundOrvieto R, Fisch B, Feldberg D. Endometrial Preparation for Patients undergoing Frozen- Thawed Embryo Transfer Cycles. In: The Art & Science of Assisted Reproductive Techniques. G. Allahbadia, R. asuray, R. Merchant, Eds. Jaypee Brothers Medical Publishers (P) Ltd. New Delhi, India, 2003, pp. 396-9.
- Background: PubMed 3951513Navot D, Laufer N, Kopolovic J, Rabinowitz R, Birkenfeld A, Lewin A, Granat M, Margalioth EJ, Schenker JG. Artificially induced endometrial cycles and establishment of pregnancies in the absence of ovaries. N Engl J Med. 1986 Mar 27;314(13):806-11. doi: 10.1056/NEJM198603273141302.
- Background: PubMed 12202415Pritts EA, Atwood AK. Luteal phase support in infertility treatment: a meta-analysis of the randomized trials. Hum Reprod. 2002 Sep;17(9):2287-99. doi: 10.1093/humrep/17.9.2287.
- Background: PubMed 8419194Meldrum DR. Female reproductive aging--ovarian and uterine factors. Fertil Steril. 1993 Jan;59(1):1-5. doi: 10.1016/s0015-0282(16)55608-8.
- Background: 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.
- Background: PubMed 15070873Tesarik J, Hazout A, Mendoza C. Enhancement of embryo developmental potential by a single administration of GnRH agonist at the time of implantation. Hum Reprod. 2004 May;19(5):1176-80. doi: 10.1093/humrep/deh235. Epub 2004 Apr 7.
- Background: PubMed 16926261Tesarik J, Hazout A, Mendoza-Tesarik R, Mendoza N, Mendoza C. Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles. Hum Reprod. 2006 Oct;21(10):2572-9. doi: 10.1093/humrep/del173. Epub 2006 Aug 22.
- Background: PubMed 25731193Orvieto R, Brengauz M, Feldman B. A novel approach to normal responder patient with repeated implantation failures--a case report. Gynecol Endocrinol. 2015 Jun;31(6):435-7. doi: 10.3109/09513590.2015.1005595. Epub 2015 Mar 3.
- Individual participant dataSharing planned: No
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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.
Raoul Orvieto, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Choriogonadotropin alfa and Triptorelin acetate in people with Embryo Transfer and Luteal Support, run by Sheba Medical Center at 1 site in Israel.
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 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 13 Dec 2016. 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 Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Eran Zilberberg, MD (+97235302882, eran.zilberberg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy (time frame: About 10-12 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 NCT02825290, 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 13 Dec 2016; AzTrials last refreshed its copy on 1 Nov 2026.