Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration.
NCT ID: NCT05980091
Last Updated: 2025-02-21
Study Results
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Basic Information
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RECRUITING
PHASE1
316 participants
INTERVENTIONAL
2023-09-22
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Group A
Embryo transfer is scheduled on the 6th full day of progesterone administration, following the initial commencement of progesterone (120 hours)
Transvaginal ultrasound
Transvaginal ultrasound throughout the HRT cycle to not only monitor endometrial development but to also exclude the presence of an ovarian dominant follicle
Serum LH, E2, P4
In conjunction with ultrasound monitoring, participants will undergo serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4) levels
Estradiol Valerate 2 MG
Participants will commence estradiol valerate 4 mg ( 2 x 2 mg) on day 2 / day 3 of menses.
Estradiol will be increased to 6 mg on day 2 of estrogen treatment, and continued at a daily dose of 6 mg (3 tablets daily)
Progesterone 100 Mg Vaginal Insert
The initial progesterone dose of 100 mg will be commenced at 13hrs and repeated at 21hrs considered day 1 (vaginal suppository) when an optimal endometrial thickness for each participant has been achieved with a trilaminar appearance. The following day (day 2) progesterone administration will be increased to 100 mg vaginally three times daily
Serum P4 day of ET
On the day of embryo transfer (ET), a blood test is taken to measure serum P4
Embryo transfer
Procedure in which embryo is transferred into the uterus
Group B
Embryo Transfer is scheduled on the 7th full day of progesterone administration, following the initial commencement of progesterone (144 hours)
Transvaginal ultrasound
Transvaginal ultrasound throughout the HRT cycle to not only monitor endometrial development but to also exclude the presence of an ovarian dominant follicle
Serum LH, E2, P4
In conjunction with ultrasound monitoring, participants will undergo serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4) levels
Estradiol Valerate 2 MG
Participants will commence estradiol valerate 4 mg ( 2 x 2 mg) on day 2 / day 3 of menses.
Estradiol will be increased to 6 mg on day 2 of estrogen treatment, and continued at a daily dose of 6 mg (3 tablets daily)
Progesterone 100 Mg Vaginal Insert
The initial progesterone dose of 100 mg will be commenced at 13hrs and repeated at 21hrs considered day 1 (vaginal suppository) when an optimal endometrial thickness for each participant has been achieved with a trilaminar appearance. The following day (day 2) progesterone administration will be increased to 100 mg vaginally three times daily
Serum P4 day of ET
On the day of embryo transfer (ET), a blood test is taken to measure serum P4
Embryo transfer
Procedure in which embryo is transferred into the uterus
Interventions
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Transvaginal ultrasound
Transvaginal ultrasound throughout the HRT cycle to not only monitor endometrial development but to also exclude the presence of an ovarian dominant follicle
Serum LH, E2, P4
In conjunction with ultrasound monitoring, participants will undergo serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4) levels
Estradiol Valerate 2 MG
Participants will commence estradiol valerate 4 mg ( 2 x 2 mg) on day 2 / day 3 of menses.
Estradiol will be increased to 6 mg on day 2 of estrogen treatment, and continued at a daily dose of 6 mg (3 tablets daily)
Progesterone 100 Mg Vaginal Insert
The initial progesterone dose of 100 mg will be commenced at 13hrs and repeated at 21hrs considered day 1 (vaginal suppository) when an optimal endometrial thickness for each participant has been achieved with a trilaminar appearance. The following day (day 2) progesterone administration will be increased to 100 mg vaginally three times daily
Serum P4 day of ET
On the day of embryo transfer (ET), a blood test is taken to measure serum P4
Embryo transfer
Procedure in which embryo is transferred into the uterus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having at least 1 euploid cryopreserved day 6 blastocyst of at least Grade BB quality.
* Endometrial trilaminar appearance on the day of progesterone start
Exclusion Criteria
* Hydrosalpinx
* Asherman syndrome
* Any known contraindications or allergy to oral estradiol or progesterone.
* Intention to treat : exclusion factors :
1. Spontaneous ovulation HRT cycle
2. Discontinuation of HRT medication
18 Years
43 Years
FEMALE
Yes
Sponsors
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ART Fertility Clinics LLC
OTHER
Responsible Party
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Principal Investigators
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Carol Coughlan, PhD
Role: PRINCIPAL_INVESTIGATOR
ART Fertility Clinics LLC
Locations
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ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
ART Fertility Clinics Dubai
Dubai, , United Arab Emirates
Countries
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Central Contacts
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Facility Contacts
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References
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Franasiak JM, Ruiz-Alonso M, Scott RT, Simon C. Both slowly developing embryos and a variable pace of luteal endometrial progression may conspire to prevent normal birth in spite of a capable embryo. Fertil Steril. 2016 Apr;105(4):861-6. doi: 10.1016/j.fertnstert.2016.02.030.
Nawroth F, Ludwig M. What is the 'ideal' duration of progesterone supplementation before the transfer of cryopreserved-thawed embryos in estrogen/progesterone replacement protocols? Hum Reprod. 2005 May;20(5):1127-34. doi: 10.1093/humrep/deh762. Epub 2005 Feb 3.
van de Vijver A, Drakopoulos P, Polyzos NP, Van Landuyt L, Mackens S, Santos-Ribeiro S, Vloeberghs V, Tournaye H, Blockeel C. Vitrified-warmed blastocyst transfer on the 5th or 7th day of progesterone supplementation in an artificial cycle: a randomised controlled trial. Gynecol Endocrinol. 2017 Oct;33(10):783-786. doi: 10.1080/09513590.2017.1318376. Epub 2017 Apr 26.
Zegers-Hochschild F, Adamson GD, Dyer S, Racowsky C, de Mouzon J, Sokol R, Rienzi L, Sunde A, Schmidt L, Cooke ID, Simpson JL, van der Poel S. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017 Sep;108(3):393-406. doi: 10.1016/j.fertnstert.2017.06.005. Epub 2017 Jul 29.
Roelens C, Santos-Ribeiro S, Becu L, Mackens S, Van Landuyt L, Racca A, De Vos M, van de Vijver A, Tournaye H, Blockeel C. Frozen-warmed blastocyst transfer after 6 or 7 days of progesterone administration: impact on live birth rate in hormone replacement therapy cycles. Fertil Steril. 2020 Jul;114(1):125-132. doi: 10.1016/j.fertnstert.2020.03.017. Epub 2020 Jun 16.
Bourdon M, Pocate-Cheriet K, Finet de Bantel A, Grzegorczyk-Martin V, Amar Hoffet A, Arbo E, Poulain M, Santulli P. Day 5 versus Day 6 blastocyst transfers: a systematic review and meta-analysis of clinical outcomes. Hum Reprod. 2019 Oct 2;34(10):1948-1964. doi: 10.1093/humrep/dez163.
Shapiro 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.
Other Identifiers
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2306-ABU-013-CC
Identifier Type: -
Identifier Source: org_study_id
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