Hormonal Replacement Frozen Embryo Transfer CyclePhase 2/3NCT05758064
The Rescue of Hormonal Replacement Frozen Embryo Transfer Cycle With Low Serum Progesterone.
A Phase 2/3 study testing Duphaston and prolutex in people with Hormonal Replacement Frozen Embryo Transfer Cycle, run by El Shatby University Hospital for Obstetrics and Gynecology at 2 sites in Egypt.
Trial summary
Frozen embryo transfer (FET) is increasingly adopted strategy in modern IVF. Among the many factors that have contributed to such change, the pursuit of an ovarian hyperstimulation syndrome free clinic has been strongly required. 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
- Hormonal Replacement Frozen Embryo Transfer Cycle
- What is being tested?
- Duphaston and prolutex
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Phase 2/3
- 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
Who may be able to join
- Patient prepared for frozen blastocyst transfer.
- Maternal age ranges from less than 40 years.
- BMI < 35kg/m2.
- Normal uterine cavity.
Who cannot join
- Uncorrected endometrial, uterine or pelvic pathology.
- Recurrent implantation failure cases.
- Patients suffering from recurrent miscarriages.
- Male factor infertility due to azoospermia
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Elshatby University Maternity Hospital
Alexandria
Aly A Hussein, MD, 00201119448000, aly.emam@alexmed.edu.eg
Sherif S Gaafar, professor
- Recruiting
Faculty of Medicine, University of Alexandria
Alexandria
Aly A Hussein, Dr, 00201119448000, aly.emam@alexmed.edu.eg
About this study
Official title: How to Rescue Hormonal Replacement Frozen Embryo Transfer Cycle With Low Serum Progesterone? A Randomized Control Trial.
Frozen embryo transfer (FET) is increasingly adopted strategy in modern IVF. Among the many factors that have contributed to such change, the pursuit of an ovarian hyperstimulation syndrome free clinic has been strongly required. Improvements in the vitrification and warming processes and the excellent cryo-survival rates have turned FET in our main tool for preventing this complication. Moreover, a freeze all strategy has proven to provide excellent or even better pregnancy rates (PRs), not only in high but also in normal responders.
While ART have rapidly evolved in the areas of embryo culture, vitrification and understanding of the embryo development, little progress has been achieved regarding endometrial preparation for FET. Undoubtedly, correct implantation requires a good quality embryo and a suitable decidualized endometrium. Artificial cycles require hormone replacement treatment (HRT) with estradiol and progesterone (P4). However, there is not a single standardized treatment described for optimal endometrial preparation and no protocol has proven superiority in terms of reproductive outcomes.(5, 6) Although artificial preparation is the most convenient method to schedule FET cycles, recent reports have highlighted a potentially detrimental effect of low P4 levels prior to FET on miscarriage and live birth rates (LBRs). These results have been observed both in homologous and oocyte recipient FET cycles(7, 8), but also in FET cycles of embryos that had undergone PGT for aneuploidies (PGT-A).(9) Additional P4 supplementation may be a way to improve reproductive outcomes in these patients.
Our open labelled randomized control study aims to investigate whether patients with low serum P4 levels the day before FET under standard HRT can benefit in terms of clinical and ongoing pregnancy and implantation rates from an individualized luteal phase support consisting in the addition of oral dydrogesterone supplementation or daily subcutaneous P4 injection.
Read the detailed description
A randomized control trial which will be conducted at El-Shatby University Maternity Hospital and private two private ART centres in Alexandria, Egypt.
120 patients in which HRT-FET cycles with low serum progesterone levels will divided into two groups :
- Group A: 60 patients will be given oral 10 mg dydrogesterone (Duphaston®, Abbott) twice daily or,
- Group B: 60 patients will be given subcutaneous injection 25mg daily (Prolutex®, IBSA).
METHODS Investigation Basal hormonal profile before initiation of treatment, a basal hormonal profile will be performed in all patients (basal FSH, LH, and estradiol levels) Pelvic ultrasound using a transvaginal probe, to assess ovaries, tubes and document uterine size, shape and endometrial thickness.
Endometrial preparation:
A transvaginal scan will be performed on the second day of the menstrual cycle to document baseline endometrial thickness.
HRT preparation of endometrium will be started day two of the cycle by administration of estradiol valerate at dose 8 mg daily.
The endometrial thickness and pattern will be assessed starting from day 10 of estradiol supplementation. If the endometrial thickness is less than 7 mm, oestradiol valerate administration will be continued and reassessed every 3 days up to 21days and if no improvement the cycle will be cancelled.
When the endometrial thickness reaches a minimum of 7 mm with a triple-line appearance, patients will start progesterone supplementation. Vaginal progesterone at a daily dose of 800 mg will administered (cyclogest suppository 400mg. twice daily). Blastocyst transfer will be done after 5 complete days of progesterone administration.
A morning serum progesterone level will be measured 24 hours before embryo transfer. If the serum progesterone level is bellow <10 ng/mL (1) rescue progesterone dose will be started before blastocyst transfer.
Patients with low serum progesterone will be randomized to receive extra progesterone supplementation in the form of either:
- Group A: oral 10 mg dydrogesterone (Duphaston®, Abbott) twice daily or,
- Group B: subcutaneous injection 25mg daily (Prolutex®, IBSA). The serum progesterone will be measured again on the day of embryo transfer and the day after.
The HRT will be continued until a pregnancy test is performed, and in cases of a positive pregnancy test, estradiol valerate and progesterone will be continued till week 10 of gestation.
III. Measuring the level of beta HCG:
The level of HCG will be measured for diagnosis of pregnancy 14 days after embryo transfer.
IV. Detection of Clinical pregnancy rate:
Transvaginal ultrasonography will be used to detect the appearance of the gestational sac with a fetal pole in the uterus two weeks after positive pregnancy test.
Cases will be followed up till the end of first trimester to detect abortion rate.
- Being tested
- Duphaston, prolutex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuphastonDrug
10 mg tablet will be given twice
prolutexDrug
subcutaneous injection daily
| Study group | Role | What they receive |
|---|---|---|
| Oral dydrogesterone | Active comparator | 60 patients in HRT frozen embryo transfer with low serum progesterone less than 10 ng/ml 24 hours before the embryo transfer will be given oral 10 mg dydrogesterone (Duphaston®, Abbott) twice daily Receives: Drug: Duphaston |
| subcutaneous progesterone | Active comparator | 60 patients in HRT frozen embryo transfer with low serum progesterone less than 10 ng/ml 24 hours before the embryo transfer will be subcutaneous injection 25mg daily (Prolutex®, IBSA). Receives: Drug: prolutex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
percentage of cases in which observation of a gestational sac with fetal heart beat by transvaginal ultrasound at 6 weeks of pregnancy
Measured: at the 6 th weeks of pregnancy
Secondary outcomes (3)
Serum progesterone level on the day of FET
Serum progesterone level on the day of FET
Measured: on the day of embryo transfer(before transfer)
Implantation rate
it is calculated as the number of intrauterine gestational sacs observed by transvaginal ultrasonography divided by the number of transferred embryos at the 6 th week of pregnancy and then multiplied by 100
Measured: at the 6 th week of pregnancy
Ongoing pregnancy rate
Assessing the difference in the ongoing pregnancy rate when the pregnancy had completed ≥20 weeks of gestation
Measured: At the 20 th week of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Jan 2023
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hormonal Replacement Frozen Embryo Transfer CycleStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- El Shatby University Hospital for Obstetrics and Gynecology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aly Hussein, El Shatby University Hospital for Obstetrics and Gynecology
- Investigators
- Aly A Hussein, Dr, Study chair, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758064
- Sponsor's protocol ID
- 0305825
- Status last verified
- Mar 2023
- First submitted
- 8 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Devroey P, Polyzos NP, Blockeel C. An OHSS-Free Clinic by segmentation of IVF treatment. Hum Reprod. 2011 Oct;26(10):2593-7. doi: 10.1093/humrep/der251. Epub 2011 Aug 9.
PubMed 21828116Chen ZJ, Shi Y, Sun Y, Zhang B, Liang X, Cao Y, Yang J, Liu J, Wei D, Weng N, Tian L, Hao C, Yang D, Zhou F, Shi J, Xu Y, Li J, Yan J, Qin Y, Zhao H, Zhang H, Legro RS. Fresh versus Frozen Embryos for Infertility in the Polycystic Ovary Syndrome. N Engl J Med. 2016 Aug 11;375(6):523-33. doi: 10.1056/NEJMoa1513873.
PubMed 27509101Wei D, Liu JY, Sun Y, Shi Y, Zhang B, Liu JQ, Tan J, Liang X, Cao Y, Wang Z, Qin Y, Zhao H, Zhou Y, Ren H, Hao G, Ling X, Zhao J, Zhang Y, Qi X, Zhang L, Deng X, Chen X, Zhu Y, Wang X, Tian LF, Lv Q, Ma X, Zhang H, Legro RS, Chen ZJ. Frozen versus fresh single blastocyst transfer in ovulatory women: a multicentre, randomised controlled trial. Lancet. 2019 Mar 30;393(10178):1310-1318. doi: 10.1016/S0140-6736(18)32843-5. Epub 2019 Feb 28.
PubMed 30827784Stormlund S, Sopa N, Zedeler A, Bogstad J, Praetorius L, Nielsen HS, Kitlinski ML, Skouby SO, Mikkelsen AL, Spangmose AL, Jeppesen JV, Khatibi A, la Cour Freiesleben N, Ziebe S, Polyzos NP, Bergh C, Humaidan P, Andersen AN, Lossl K, Pinborg A. Freeze-all versus fresh blastocyst transfer strategy during in vitro fertilisation in women with regular menstrual cycles: multicentre randomised controlled trial. BMJ. 2020 Aug 5;370:m2519. doi: 10.1136/bmj.m2519.
PubMed 32759285Ghobara T, Gelbaya TA, Ayeleke RO. Cycle regimens for frozen-thawed embryo transfer. Cochrane Database Syst Rev. 2017 Jul 5;7(7):CD003414. doi: 10.1002/14651858.CD003414.pub3.
PubMed 28675921Groenewoud ER, Cohlen BJ, Macklon NS. Programming the endometrium for deferred transfer of cryopreserved embryos: hormone replacement versus modified natural cycles. Fertil Steril. 2018 May;109(5):768-774. doi: 10.1016/j.fertnstert.2018.02.135.
PubMed 29778369Cedrin-Durnerin I, Isnard T, Mahdjoub S, Sonigo C, Seroka A, Comtet M, Herbemont C, Sifer C, Grynberg M. Serum progesterone concentration and live birth rate in frozen-thawed embryo transfers with hormonally prepared endometrium. Reprod Biomed Online. 2019 Mar;38(3):472-480. doi: 10.1016/j.rbmo.2018.11.026. Epub 2019 Jan 5.
PubMed 30642638Volovsky M, Pakes C, Rozen G, Polyakov A. Do serum progesterone levels on day of embryo transfer influence pregnancy outcomes in artificial frozen-thaw cycles? J Assist Reprod Genet. 2020 May;37(5):1129-1135. doi: 10.1007/s10815-020-01713-w. Epub 2020 Feb 10.
PubMed 32043182Gaggiotti-Marre S, Martinez F, Coll L, Garcia S, Alvarez M, Parriego M, Barri PN, Polyzos N, Coroleu B. Low serum progesterone the day prior to frozen embryo transfer of euploid embryos is associated with significant reduction in live birth rates. Gynecol Endocrinol. 2019 May;35(5):439-442. doi: 10.1080/09513590.2018.1534952. Epub 2018 Dec 26.
PubMed 30585507
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Rescue Hormonal Replacement Frozen Embryo Transfer Cycle With Low Serum Progesterone? A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT05758064
- Acronym / sponsor ID
- 0305825
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- El Shatby University Hospital for Obstetrics and GynecologyUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Mar 2023 (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.
Frozen embryo transfer (FET) is increasingly adopted strategy in modern IVF. Among the many factors that have contributed to such change, the pursuit of an ovarian hyperstimulation syndrome free clinic has been strongly required. Improvements in the vitrification and warming processes and the excellent cryo-survival rates have turned FET in our main tool for preventing this complication. Moreover, a freeze all strategy has proven to provide excellent or even better pregnancy rates (PRs), not only in high but also in normal responders.
While ART have rapidly evolved in the areas of embryo culture, vitrification and understanding of the embryo development, little progress has been achieved regarding endometrial preparation for FET. Undoubtedly, correct implantation requires a good quality embryo and a suitable decidualized endometrium. Artificial cycles require hormone replacement treatment (HRT) with estradiol and progesterone (P4). However, there is not a single standardized treatment described for optimal endometrial preparation and no protocol has proven superiority in terms of reproductive outcomes.(5, 6) Although artificial preparation is the most convenient method to schedule FET cycles, recent reports have highlighted a potentially detrimental effect of low P4 levels prior to FET on miscarriage and live birth rates (LBRs). These results have been observed both in homologous and oocyte recipient FET cycles(7, 8), but also in FET cycles of embryos that had undergone PGT for aneuploidies (PGT-A).(9) Additional P4 supplementation may be a way to improve reproductive outcomes in these patients.
Our open labelled randomized control study aims to investigate whether patients with low serum P4 levels the day before FET under standard HRT can benefit in terms of clinical and ongoing pregnancy and implantation rates from an individualized luteal phase support consisting in the addition of oral dydrogesterone supplementation or daily subcutaneous P4 injection.
Detailed description
A randomized control trial which will be conducted at El-Shatby University Maternity Hospital and private two private ART centres in Alexandria, Egypt.
120 patients in which HRT-FET cycles with low serum progesterone levels will divided into two groups :
- Group A: 60 patients will be given oral 10 mg dydrogesterone (Duphaston®, Abbott) twice daily or,
- Group B: 60 patients will be given subcutaneous injection 25mg daily (Prolutex®, IBSA).
METHODS Investigation Basal hormonal profile before initiation of treatment, a basal hormonal profile will be performed in all patients (basal FSH, LH, and estradiol levels) Pelvic ultrasound using a transvaginal probe, to assess ovaries, tubes and document uterine size, shape and endometrial thickness.
Endometrial preparation:
A transvaginal scan will be performed on the second day of the menstrual cycle to document baseline endometrial thickness.
HRT preparation of endometrium will be started day two of the cycle by administration of estradiol valerate at dose 8 mg daily.
The endometrial thickness and pattern will be assessed starting from day 10 of estradiol supplementation. If the endometrial thickness is less than 7 mm, oestradiol valerate administration will be continued and reassessed every 3 days up to 21days and if no improvement the cycle will be cancelled.
When the endometrial thickness reaches a minimum of 7 mm with a triple-line appearance, patients will start progesterone supplementation. Vaginal progesterone at a daily dose of 800 mg will administered (cyclogest suppository 400mg. twice daily). Blastocyst transfer will be done after 5 complete days of progesterone administration.
A morning serum progesterone level will be measured 24 hours before embryo transfer. If the serum progesterone level is bellow <10 ng/mL (1) rescue progesterone dose will be started before blastocyst transfer.
Patients with low serum progesterone will be randomized to receive extra progesterone supplementation in the form of either:
- Group A: oral 10 mg dydrogesterone (Duphaston®, Abbott) twice daily or,
- Group B: subcutaneous injection 25mg daily (Prolutex®, IBSA). The serum progesterone will be measured again on the day of embryo transfer and the day after.
The HRT will be continued until a pregnancy test is performed, and in cases of a positive pregnancy test, estradiol valerate and progesterone will be continued till week 10 of gestation.
III. Measuring the level of beta HCG:
The level of HCG will be measured for diagnosis of pregnancy 14 days after embryo transfer.
IV. Detection of Clinical pregnancy rate:
Transvaginal ultrasonography will be used to detect the appearance of the gestational sac with a fetal pole in the uterus two weeks after positive pregnancy test.
Cases will be followed up till the end of first trimester to detect abortion rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral dydrogesterone | Active comparator | Drug: Duphaston60 patients in HRT frozen embryo transfer with low serum progesterone less than 10 ng/ml 24 hours before the embryo transfer will be given oral 10 mg dydrogesterone (Duphaston®, Abbott) twice daily |
| subcutaneous progesterone | Active comparator | Drug: prolutex60 patients in HRT frozen embryo transfer with low serum progesterone less than 10 ng/ml 24 hours before the embryo transfer will be subcutaneous injection 25mg daily (Prolutex®, IBSA). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient prepared for frozen blastocyst transfer.
- Maternal age ranges from less than 40 years.
- BMI < 35kg/m2.
- Normal uterine cavity.
Key exclusion criteria (4 listed)
- Uncorrected endometrial, uterine or pelvic pathology.
- Recurrent implantation failure cases.
- Patients suffering from recurrent miscarriages.
- Male factor infertility due to azoospermia
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 |
|---|---|---|
| Duphaston10 mg tablet will be given twice | Drug | Oral dydrogesterone |
| prolutexsubcutaneous injection daily | Drug | subcutaneous progesterone |
Primary outcome
Clinical pregnancy rate
Time frame: at the 6 th weeks of pregnancy
percentage of cases in which observation of a gestational sac with fetal heart beat by transvaginal ultrasound at 6 weeks of pregnancy
3 secondary outcomes
Serum progesterone level on the day of FET
Time frame: on the day of embryo transfer(before transfer)
Implantation rate
Time frame: at the 6 th week of pregnancy
Ongoing pregnancy rate
Time frame: At the 20 th week of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 21828116Devroey P, Polyzos NP, Blockeel C. An OHSS-Free Clinic by segmentation of IVF treatment. Hum Reprod. 2011 Oct;26(10):2593-7. doi: 10.1093/humrep/der251. Epub 2011 Aug 9.
- Background: PubMed 27509101Chen ZJ, Shi Y, Sun Y, Zhang B, Liang X, Cao Y, Yang J, Liu J, Wei D, Weng N, Tian L, Hao C, Yang D, Zhou F, Shi J, Xu Y, Li J, Yan J, Qin Y, Zhao H, Zhang H, Legro RS. Fresh versus Frozen Embryos for Infertility in the Polycystic Ovary Syndrome. N Engl J Med. 2016 Aug 11;375(6):523-33. doi: 10.1056/NEJMoa1513873.
- Background: PubMed 30827784Wei D, Liu JY, Sun Y, Shi Y, Zhang B, Liu JQ, Tan J, Liang X, Cao Y, Wang Z, Qin Y, Zhao H, Zhou Y, Ren H, Hao G, Ling X, Zhao J, Zhang Y, Qi X, Zhang L, Deng X, Chen X, Zhu Y, Wang X, Tian LF, Lv Q, Ma X, Zhang H, Legro RS, Chen ZJ. Frozen versus fresh single blastocyst transfer in ovulatory women: a multicentre, randomised controlled trial. Lancet. 2019 Mar 30;393(10178):1310-1318. doi: 10.1016/S0140-6736(18)32843-5. Epub 2019 Feb 28.
- Background: PubMed 32759285Stormlund S, Sopa N, Zedeler A, Bogstad J, Praetorius L, Nielsen HS, Kitlinski ML, Skouby SO, Mikkelsen AL, Spangmose AL, Jeppesen JV, Khatibi A, la Cour Freiesleben N, Ziebe S, Polyzos NP, Bergh C, Humaidan P, Andersen AN, Lossl K, Pinborg A. Freeze-all versus fresh blastocyst transfer strategy during in vitro fertilisation in women with regular menstrual cycles: multicentre randomised controlled trial. BMJ. 2020 Aug 5;370:m2519. doi: 10.1136/bmj.m2519.
- Background: PubMed 28675921Ghobara T, Gelbaya TA, Ayeleke RO. Cycle regimens for frozen-thawed embryo transfer. Cochrane Database Syst Rev. 2017 Jul 5;7(7):CD003414. doi: 10.1002/14651858.CD003414.pub3.
- Background: PubMed 29778369Groenewoud ER, Cohlen BJ, Macklon NS. Programming the endometrium for deferred transfer of cryopreserved embryos: hormone replacement versus modified natural cycles. Fertil Steril. 2018 May;109(5):768-774. doi: 10.1016/j.fertnstert.2018.02.135.
- Background: PubMed 30642638Cedrin-Durnerin I, Isnard T, Mahdjoub S, Sonigo C, Seroka A, Comtet M, Herbemont C, Sifer C, Grynberg M. Serum progesterone concentration and live birth rate in frozen-thawed embryo transfers with hormonally prepared endometrium. Reprod Biomed Online. 2019 Mar;38(3):472-480. doi: 10.1016/j.rbmo.2018.11.026. Epub 2019 Jan 5.
- Background: PubMed 32043182Volovsky M, Pakes C, Rozen G, Polyakov A. Do serum progesterone levels on day of embryo transfer influence pregnancy outcomes in artificial frozen-thaw cycles? J Assist Reprod Genet. 2020 May;37(5):1129-1135. doi: 10.1007/s10815-020-01713-w. Epub 2020 Feb 10.
- Background: PubMed 30585507Gaggiotti-Marre S, Martinez F, Coll L, Garcia S, Alvarez M, Parriego M, Barri PN, Polyzos N, Coroleu B. Low serum progesterone the day prior to frozen embryo transfer of euploid embryos is associated with significant reduction in live birth rates. Gynecol Endocrinol. 2019 May;35(5):439-442. doi: 10.1080/09513590.2018.1534952. Epub 2018 Dec 26.
- Individual participant dataSharing planned: Undecided
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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.
Aly A Hussein, Dr study chair
University of Alexandria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Duphaston and prolutex in people with Hormonal Replacement Frozen Embryo Transfer Cycle, run by El Shatby University Hospital for Obstetrics and Gynecology at 2 sites 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 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 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Aly A Hussein, Dr (00201119448000, aly.emam@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: at the 6 th weeks of 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 NCT05758064, which also lists 9 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 7 Mar 2023.