Recurrent Implantation FailureNCT04998279
Intrauterine Infusion of GCSF and Reproductive Outcomes in Infertile Women with History of RIF
An observational study of Recurrent Implantation Failure and Granulocyte Colony-Stimulating Factor, run by Cairo University at 1 site in Egypt.
Trial summary
Intrauterine infusion of granulocyte colony stimulating factor and reproductive outcomes in infertile women with history of recurrent implantation failure Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Recurrent Implantation Failure, Granulocyte Colony-Stimulating Factor, Infertility
- What is being tested?
- Granulocyte Colony-Stimulating Factor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 25 Sep 2024
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertility patients undergoing ICSI trials at Cairo university school of Medicine IVF unit.
Who may be able to join
- Age group (18-38)
- History of at least 2 previous IVF or ICSI trial failures with ET of at least 2 good quality embryos in each trial.
- Endometrial cavity within normal anatomy as assessed with transvaginal ultrasound (TV-US) with or without hysteroscopy and HSG if needed.
- Availability of good quality embryos (at least 2 grade A embryos) for ET in the investigated trial
Who cannot join
- Any factor which may affect quality of embryos transferred or endometrial receptivity and embryo growth, like:
- Severe male factor infertility
- Poor ovarian reserve (according to ESHRE criteria) 1
- Uterine anatomic factor (eg polyp, intramural fibroid, endometrial septum, intrauterine synechiae .. etc) as well as endometritis
- Immunological disorder (eg: SLE, APS, … etc)
- Thyroid or adrenal dysfunction
Show all 10Show fewer
- Thrombophilia history or tendency as proven by labs in suspected women
- Untreated hyperprolactinemia
- Genetic abnormalities in the infertile couple
- Chronic hematologic, renal or liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrauterine Infusion of Granulocyte Colony Stimulating Factor and Reproductive Outcomes in Infertile Women with History of Recurrent Implantation Failure
Intrauterine infusion of granulocyte colony stimulating factor and reproductive outcomes in infertile women with history of recurrent implantation failure
Read the detailed description
- Despite the developments in fertility treatment protocols, repeated implantation failure (RIF) still remains a challenging problem for patients and clinicians, it causes deep impact on the quality of life and financial burden, because the majority of failed invitro fertilization- embryo transfer (IVF-ET) cycles exhibit lack of implantation, endometrial receptivity is the limiting factor for implantation and success of IVF programs. Repeated implantation failure (RIF) is defined as pregnancy failure after 2-6 times with at least 10 high quality embryos transferred into the uterus.
- Granulocyte-colony stimulating factors (G-CSF) is synthesized in the reproductive tract naturally, it is a hematopoietic lineage-specific cytokine which is known for its specific effects on the activation of intracellular signaling pathways that are associated with the cell proliferation, differentiation, and stimulation of hematopoietic cells of the neutrophilic granulocyte lineage; which act on macrophages of decidual cells and finally affect implantation.
- During the maturation of the pre-ovulatory follicle, G-CSF receptor expression increases; this also takes place in human endometrium and luteinized granulosa cells. G-CSF receptors also exist on the trophoblast with the highest G-CSF receptor expression occurs in the first trimester. G-CSF effect on recruitment of type 2 T helper cytokine secretion, activation of T regulatory cells, modulation of uterine natural killer and dendritic cells cytotoxicity, as well as endometrium angiogenesis as a result has an essential role on early cross talk between embryo and uterine endometrium. G-CSF stimulates the proliferation and differentiation of endometrial cells by CAMP increase in stromal cell through paracrine and autocrine signaling pathway.
- Studies showed that elevated G-CSF concentrations on follicular fluid increased implantation rate and can improve IVF outcome, it increase the proportion of embryos that develop to the blastocyst stage from 30-76%. Also G-CSF supplemented to the embryo culture medium improves implantation rate. G-CSF can be effective treatment in patient with history of implantation failure and can improve endometrium growth. Also G-CSF may increase pregnancy rate especially in women with thin endometrium.
- In a recent well-designed trial on patients with thin endometrium in which embryo transfer was cancelled with G-CSF treatment in subsequent frozen embryo transfer (FET) cycles, significantly higher implantation rate (31.5% versus 13.9%, P < .01) and clinical pregnancy rate (48.1% vs. 25%, P < .01) was found in those treated with G-CSF in comparison with controls but live birth rate was not statistically significant (33.3% vs. 17.3%).
- In a recent meta-analysis, it was found that the use of G-CSF was associated with significantly higher biochemical (RR 2.385 95% CI:1.414, 4.023) and clinical pregnancy rates (RR 2.312, 95% CI: 1.444, 3.701) among women with thin endometrium or repeated IVF failures in the general population when compared with no treatment or placebos.
- In one of two recent trials with similar patient selection and disease condition, 0.5 ml (300 µg/ml) G-CSF infusion intrauterine at the day of ovum pickup followed by grade A embryo transfer at day 3 was associated with significantly higher pregnancy and implantation rate. 3In the other trial however, the treated group received the same dose of G-CSF subcutaneously 30 min before blastocyst embryo transfer at day 5, there was higher clinical pregnancy, live birth rate and lower abortion rate; but all were not statistically significant.
- This study evaluates the effects of the single dose G-CSF intrauterine infusion in a group of patients with unexplained RIFs 3 days before ET of good quality embryos.
- Being tested
- Granulocyte Colony-Stimulating Factor, placebo
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte Colony-Stimulating FactorDrug
Also called filgrastim
Granulocyte-colony stimulating factors (G-CSF) is synthesized in the reproductive tract naturally, it is a hematopoietic lineage-specific cytokine which is known for its specific effects on the activation of intracellular signaling pathways that are associated with the cell proliferation, differentiation, and stimulation of hematopoietic cells of the neutrophilic granulocyte lineage; which act on macrophages of decidual cells and finally affect implantation
placeboOther
mock test without injection of G-CSF
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Not described Receives: Drug: Granulocyte Colony-Stimulating Factor | |
| Control group | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
(GS with viable embryo 4 weeks after ET)
Measured: 4 weeks after ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start1 Sep 2019
- Primary completion30 Aug 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Recurrent Implantation FailureStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Tarek Elkhateb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998279
- Sponsor's protocol ID
- 2464949
- Status last verified
- Sep 2024
- First submitted
- 26 Jul 2021
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.
PubMed 21505041Bashiri A, Halper KI, Orvieto R. Recurrent Implantation Failure-update overview on etiology, diagnosis, treatment and future directions. Reprod Biol Endocrinol. 2018 Dec 5;16(1):121. doi: 10.1186/s12958-018-0414-2.
PubMed 30518389Eftekhar M, Miraj S, Farid Mojtahedi M, Neghab N. Efficacy of Intrauterine infusion of granulocyte colony stimulating factor on patients with history of implantation failure: A randomized control trial. Int J Reprod Biomed. 2016 Nov;14(11):687-690.
PubMed 27981253Reda A, Hamid AS, Mostafa R, Refaei E. Comparison between findings of saline infusion sonohysterography and office hysteroscopy in patients with recurrent implantation failure. J Hum Reprod Sci. 2016 Oct-Dec;9(4):236-240. doi: 10.4103/0974-1208.197661.
PubMed 28216911Arefi S, Fazeli E, Esfahani M, Borhani N, Yamini N, Hosseini A, Farifteh F. Granulocyte-colony stimulating factor may improve pregnancy outcome in patients with history of unexplained recurrent implantation failure: An RCT. Int J Reprod Biomed. 2018 May;16(5):299-304.
PubMed 30027145Kahyaoglu I, Yilmaz N, Timur H, Inal HA, Erkaya S. Granulocyte colony-stimulating factor: A relation between serum and follicular fluid levels and in-vitro fertilization outcome in patients with polycystic ovary syndrome. Cytokine. 2015 Jul;74(1):113-6. doi: 10.1016/j.cyto.2014.09.002. Epub 2014 Sep 23.
PubMed 25258001Sugita K, Hayakawa S, Karasaki-Suzuki M, Hagiwara H, Chishima F, Aleemuzaman S, Li JA, Nishinarita S, Yamamoto T. Granulocyte colony stimulation factor (G-CSF) suppresses interleukin (IL)-12 and/or IL-2 induced interferon (IFN)-gamma production and cytotoxicity of decidual mononuclear cells. Am J Reprod Immunol. 2003 Jul;50(1):83-9. doi: 10.1034/j.1600-0897.2003.00024.x.
PubMed 14506932Rahmati M, Petitbarat M, Dubanchet S, Bensussan A, Chaouat G, Ledee N. Colony Stimulating Factors 1, 2, 3 and early pregnancy steps: from bench to bedside. J Reprod Immunol. 2015 Jun;109:1-6. doi: 10.1016/j.jri.2015.01.005. Epub 2015 Feb 11.
PubMed 25721620Meier P, Gloekler S, Oezdemir B, Indermuehle A, Traupe T, Vogel R, de Marchi S, Seiler C. G-CSF induced arteriogenesis in humans: molecular insights into a randomized controlled trial. Curr Vasc Pharmacol. 2013 Jan;11(1):38-46.
PubMed 23391421Gleicher N, Vidali A, Barad DH. Successful treatment of unresponsive thin endometrium. Fertil Steril. 2011 May;95(6):2123.e13-7. doi: 10.1016/j.fertnstert.2011.01.143. Epub 2011 Feb 16.
PubMed 21324451Gleicher N, Kim A, Michaeli T, Lee HJ, Shohat-Tal A, Lazzaroni E, Barad DH. A pilot cohort study of granulocyte colony-stimulating factor in the treatment of unresponsive thin endometrium resistant to standard therapies. Hum Reprod. 2013 Jan;28(1):172-7. doi: 10.1093/humrep/des370. Epub 2012 Oct 18.
PubMed 23081869Xu B, Zhang Q, Hao J, Xu D, Li Y. Two protocols to treat thin endometrium with granulocyte colony-stimulating factor during frozen embryo transfer cycles. Reprod Biomed Online. 2015 Apr;30(4):349-58. doi: 10.1016/j.rbmo.2014.12.006. Epub 2014 Dec 30.
PubMed 25682303Li J, Mo S, Chen Y. The effect of G-CSF on infertile women undergoing IVF treatment: A meta-analysis. Syst Biol Reprod Med. 2017 Aug;63(4):239-247. doi: 10.1080/19396368.2017.1287225. Epub 2017 Feb 28.
PubMed 28632452Elkhateb I, Fahmy R, Ramadan W, Mourad A, El-Demiry NM, Shohayeb A. Granulocyte colony-stimulating factor for recurrent implantation failure: the results of a 5-years cohort study. Sci Rep. 2025 Nov 18;15(1):40390. doi: 10.1038/s41598-025-24587-3.
PubMed 41254175
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Infusion of Granulocyte Colony Stimulating Factor and Reproductive Outcomes in Infertile Women with History of Recurrent Implantation Failure
- ClinicalTrials.gov ID
- NCT04998279
- Acronym / sponsor ID
- 2464949
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 10 Aug 2021 (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.
Intrauterine infusion of granulocyte colony stimulating factor and reproductive outcomes in infertile women with history of recurrent implantation failure
Detailed description
- Despite the developments in fertility treatment protocols, repeated implantation failure (RIF) still remains a challenging problem for patients and clinicians, it causes deep impact on the quality of life and financial burden, because the majority of failed invitro fertilization- embryo transfer (IVF-ET) cycles exhibit lack of implantation, endometrial receptivity is the limiting factor for implantation and success of IVF programs. Repeated implantation failure (RIF) is defined as pregnancy failure after 2-6 times with at least 10 high quality embryos transferred into the uterus.
- Granulocyte-colony stimulating factors (G-CSF) is synthesized in the reproductive tract naturally, it is a hematopoietic lineage-specific cytokine which is known for its specific effects on the activation of intracellular signaling pathways that are associated with the cell proliferation, differentiation, and stimulation of hematopoietic cells of the neutrophilic granulocyte lineage; which act on macrophages of decidual cells and finally affect implantation.
- During the maturation of the pre-ovulatory follicle, G-CSF receptor expression increases; this also takes place in human endometrium and luteinized granulosa cells. G-CSF receptors also exist on the trophoblast with the highest G-CSF receptor expression occurs in the first trimester. G-CSF effect on recruitment of type 2 T helper cytokine secretion, activation of T regulatory cells, modulation of uterine natural killer and dendritic cells cytotoxicity, as well as endometrium angiogenesis as a result has an essential role on early cross talk between embryo and uterine endometrium. G-CSF stimulates the proliferation and differentiation of endometrial cells by CAMP increase in stromal cell through paracrine and autocrine signaling pathway.
- Studies showed that elevated G-CSF concentrations on follicular fluid increased implantation rate and can improve IVF outcome, it increase the proportion of embryos that develop to the blastocyst stage from 30-76%. Also G-CSF supplemented to the embryo culture medium improves implantation rate. G-CSF can be effective treatment in patient with history of implantation failure and can improve endometrium growth. Also G-CSF may increase pregnancy rate especially in women with thin endometrium.
- In a recent well-designed trial on patients with thin endometrium in which embryo transfer was cancelled with G-CSF treatment in subsequent frozen embryo transfer (FET) cycles, significantly higher implantation rate (31.5% versus 13.9%, P < .01) and clinical pregnancy rate (48.1% vs. 25%, P < .01) was found in those treated with G-CSF in comparison with controls but live birth rate was not statistically significant (33.3% vs. 17.3%).
- In a recent meta-analysis, it was found that the use of G-CSF was associated with significantly higher biochemical (RR 2.385 95% CI:1.414, 4.023) and clinical pregnancy rates (RR 2.312, 95% CI: 1.444, 3.701) among women with thin endometrium or repeated IVF failures in the general population when compared with no treatment or placebos.
- In one of two recent trials with similar patient selection and disease condition, 0.5 ml (300 µg/ml) G-CSF infusion intrauterine at the day of ovum pickup followed by grade A embryo transfer at day 3 was associated with significantly higher pregnancy and implantation rate. 3In the other trial however, the treated group received the same dose of G-CSF subcutaneously 30 min before blastocyst embryo transfer at day 5, there was higher clinical pregnancy, live birth rate and lower abortion rate; but all were not statistically significant.
- This study evaluates the effects of the single dose G-CSF intrauterine infusion in a group of patients with unexplained RIFs 3 days before ET of good quality embryos.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Drug: Granulocyte Colony-Stimulating Factor |
| Control group | – | Other: placebo |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertility patients undergoing ICSI trials at Cairo university school of Medicine IVF unit.
Key inclusion criteria (4 listed)
- Age group (18-38)
- History of at least 2 previous IVF or ICSI trial failures with ET of at least 2 good quality embryos in each trial.
- Endometrial cavity within normal anatomy as assessed with transvaginal ultrasound (TV-US) with or without hysteroscopy and HSG if needed.
- Availability of good quality embryos (at least 2 grade A embryos) for ET in the investigated trial
Key exclusion criteria (10 listed)
- Any factor which may affect quality of embryos transferred or endometrial receptivity and embryo growth, like:
- Severe male factor infertility
- Poor ovarian reserve (according to ESHRE criteria) 1
- Uterine anatomic factor (eg polyp, intramural fibroid, endometrial septum, intrauterine synechiae .. etc) as well as endometritis
- Immunological disorder (eg: SLE, APS, … etc)
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 |
|---|---|---|
| Granulocyte Colony-Stimulating FactorAlso: filgrastimGranulocyte-colony stimulating factors (G-CSF) is synthesized in the reproductive tract naturally, it is a hematopoietic lineage-specific cytokine which is known for its specific effects on the activation of intracellular signaling pathways that are associated with the cell proliferation, differentiation, and stimulation of hematopoietic cells of the neutrophilic granulocyte lineage; which act on macrophages of decidual cells and finally affect implantation | Drug | Intervention group |
| placebomock test without injection of G-CSF | Other | Control group |
Primary outcome
Clinical pregnancy rate
Time frame: 4 weeks after ET
(GS with viable embryo 4 weeks after ET)
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 1 Oct 2024.
- Background: PubMed 21505041Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.
- Background: PubMed 30518389Bashiri A, Halper KI, Orvieto R. Recurrent Implantation Failure-update overview on etiology, diagnosis, treatment and future directions. Reprod Biol Endocrinol. 2018 Dec 5;16(1):121. doi: 10.1186/s12958-018-0414-2.
- Background: PubMed 27981253Eftekhar M, Miraj S, Farid Mojtahedi M, Neghab N. Efficacy of Intrauterine infusion of granulocyte colony stimulating factor on patients with history of implantation failure: A randomized control trial. Int J Reprod Biomed. 2016 Nov;14(11):687-690.
- Background: PubMed 28216911Reda A, Hamid AS, Mostafa R, Refaei E. Comparison between findings of saline infusion sonohysterography and office hysteroscopy in patients with recurrent implantation failure. J Hum Reprod Sci. 2016 Oct-Dec;9(4):236-240. doi: 10.4103/0974-1208.197661.
- Background: PubMed 30027145Arefi S, Fazeli E, Esfahani M, Borhani N, Yamini N, Hosseini A, Farifteh F. Granulocyte-colony stimulating factor may improve pregnancy outcome in patients with history of unexplained recurrent implantation failure: An RCT. Int J Reprod Biomed. 2018 May;16(5):299-304.
- Background: PubMed 25258001Kahyaoglu I, Yilmaz N, Timur H, Inal HA, Erkaya S. Granulocyte colony-stimulating factor: A relation between serum and follicular fluid levels and in-vitro fertilization outcome in patients with polycystic ovary syndrome. Cytokine. 2015 Jul;74(1):113-6. doi: 10.1016/j.cyto.2014.09.002. Epub 2014 Sep 23.
- Background: PubMed 14506932Sugita K, Hayakawa S, Karasaki-Suzuki M, Hagiwara H, Chishima F, Aleemuzaman S, Li JA, Nishinarita S, Yamamoto T. Granulocyte colony stimulation factor (G-CSF) suppresses interleukin (IL)-12 and/or IL-2 induced interferon (IFN)-gamma production and cytotoxicity of decidual mononuclear cells. Am J Reprod Immunol. 2003 Jul;50(1):83-9. doi: 10.1034/j.1600-0897.2003.00024.x.
- Background: PubMed 25721620Rahmati M, Petitbarat M, Dubanchet S, Bensussan A, Chaouat G, Ledee N. Colony Stimulating Factors 1, 2, 3 and early pregnancy steps: from bench to bedside. J Reprod Immunol. 2015 Jun;109:1-6. doi: 10.1016/j.jri.2015.01.005. Epub 2015 Feb 11.
- Background: PubMed 23391421Meier P, Gloekler S, Oezdemir B, Indermuehle A, Traupe T, Vogel R, de Marchi S, Seiler C. G-CSF induced arteriogenesis in humans: molecular insights into a randomized controlled trial. Curr Vasc Pharmacol. 2013 Jan;11(1):38-46.
- Background: PubMed 21324451Gleicher N, Vidali A, Barad DH. Successful treatment of unresponsive thin endometrium. Fertil Steril. 2011 May;95(6):2123.e13-7. doi: 10.1016/j.fertnstert.2011.01.143. Epub 2011 Feb 16.
- Background: PubMed 23081869Gleicher N, Kim A, Michaeli T, Lee HJ, Shohat-Tal A, Lazzaroni E, Barad DH. A pilot cohort study of granulocyte colony-stimulating factor in the treatment of unresponsive thin endometrium resistant to standard therapies. Hum Reprod. 2013 Jan;28(1):172-7. doi: 10.1093/humrep/des370. Epub 2012 Oct 18.
- Background: PubMed 25682303Xu B, Zhang Q, Hao J, Xu D, Li Y. Two protocols to treat thin endometrium with granulocyte colony-stimulating factor during frozen embryo transfer cycles. Reprod Biomed Online. 2015 Apr;30(4):349-58. doi: 10.1016/j.rbmo.2014.12.006. Epub 2014 Dec 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Recurrent Implantation Failure and Granulocyte Colony-Stimulating Factor, run by Cairo University at 1 site in Egypt.
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 10 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 1 Oct 2024. 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 Egypt. 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?
Clinical pregnancy rate (time frame: 4 weeks after ET). 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 NCT04998279, which also lists 14 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 1 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.