Study Results
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Basic Information
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NOT_YET_RECRUITING
PHASE3
336 participants
INTERVENTIONAL
2024-12-05
2027-12-01
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
TREATMENT
NONE
Study Groups
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P4mNC group
On days 8-12 of the menstrual cycle (MC), depending on the length of the patient's MC, transvaginal ultrasound is used to monitor follicular development and endometrial growth. Vaginal micronized progesterone (Utrogestan, Besins, Belgium) is started at 200 mg in the afternoon and 200 mg in the evening when the dominant follicle reached ≥16 mm and the endometrial thickness is at least 7 mm. A blastocyst is transferred on day 5 after the addition of progesterone. On day 14 after blastocyst transfer, serum β-hCG levels are measured. Upon positive serum pregnancy testing, progesterone support will continue until 8-10 weeks of gestation. However, afternoon progesterone use is eliminated for 30 days after embryo transfer.
Progesterone-modified natural cycle preparation for frozen embryo transfer
A novel endometrial preparation protocol that optimizes the natural cycle, whereby as long as the thickness of the endometrium is suitable for embryo transfer, vaginal progesterone can be used to transform the endometrium before ovulation and subsequently FET.
HRT group
Endometrial preparation will begin on the second day of the menstrual cycle with oral estradiol (E2) valerate at a dose of 2 mg twice daily. When the patient's endometrial thickness is ≥7 mm, vaginal progesterone administration will be initiated at a dose of 200 mg 3 times daily. On day 5 of the progesterone administration, blastocysts are thawed and transferred. For patients with endometrial thickness \<7 mm, patients continued oral E2 until the endometrium is ≥7 mm. On day 14 after blastocyst transfer, serum β-hCG levels are measured. Upon positive serum pregnancy testing, E2 and progesterone supplementation is continued for 8-10 weeks of gestation.
Hormone replacement therapy cycle preparation for frozen embryo transfer
A traditional endometrial preparation protocol is used for FET, which involves using fixed or flexible exogenous estradiol for artificial cycles. This protocol typically involves starting exogenous estradiol on day 3 or 4 of the cycle, continuing for 7-10 days, and then discontinuing. Upon determining that the endometrial thickness meets the standard, progesterone conversion of the endometrium can be performed.
Interventions
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Progesterone-modified natural cycle preparation for frozen embryo transfer
A novel endometrial preparation protocol that optimizes the natural cycle, whereby as long as the thickness of the endometrium is suitable for embryo transfer, vaginal progesterone can be used to transform the endometrium before ovulation and subsequently FET.
Hormone replacement therapy cycle preparation for frozen embryo transfer
A traditional endometrial preparation protocol is used for FET, which involves using fixed or flexible exogenous estradiol for artificial cycles. This protocol typically involves starting exogenous estradiol on day 3 or 4 of the cycle, continuing for 7-10 days, and then discontinuing. Upon determining that the endometrial thickness meets the standard, progesterone conversion of the endometrium can be performed.
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) 18-35 kg/m2
* Having regular ovulatory cycles
Exclusion Criteria
* Medical contraindications to estrogen and progesterone therapy
* Illnesses contraindicating assisted reproductive technology or pregnancy
* History of recurrent implantation failures (\> 2 embryo transfer failures)
21 Years
44 Years
FEMALE
No
Sponsors
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Shandong University of Traditional Chinese Medicine
OTHER
Responsible Party
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Jing-Yan Song
Prof.
Principal Investigators
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Zhen-Gao Sun, MD
Role: PRINCIPAL_INVESTIGATOR
Shandong University of Traditional Chinese Medicine
Central Contacts
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References
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Inhorn MC, Patrizio P. Infertility around the globe: new thinking on gender, reproductive technologies and global movements in the 21st century. Hum Reprod Update. 2015 Jul-Aug;21(4):411-26. doi: 10.1093/humupd/dmv016. Epub 2015 Mar 22.
Mascarenhas MN, Cheung H, Mathers CD, Stevens GA. Measuring infertility in populations: constructing a standard definition for use with demographic and reproductive health surveys. Popul Health Metr. 2012 Aug 31;10(1):17. doi: 10.1186/1478-7954-10-17.
Doody KJ. Cryopreservation and delayed embryo transfer-assisted reproductive technology registry and reporting implications. Fertil Steril. 2014 Jul;102(1):27-31. doi: 10.1016/j.fertnstert.2014.04.048. Epub 2014 Jun 4.
Zhang Y, Fu X, Gao S, Gao S, Gao S, Ma J, Chen ZJ. Preparation of the endometrium for frozen embryo transfer: an update on clinical practices. Reprod Biol Endocrinol. 2023 Jun 8;21(1):52. doi: 10.1186/s12958-023-01106-5.
Roelens C, Blockeel C. Impact of different endometrial preparation protocols before frozen embryo transfer on pregnancy outcomes: a review. Fertil Steril. 2022 Nov;118(5):820-827. doi: 10.1016/j.fertnstert.2022.09.003.
Gu F, Wu Y, Tan M, Hu R, Chen Y, Li X, Lin B, Duan Y, Zhou C, Li P, Ma W, Xu Y. Programmed frozen embryo transfer cycle increased risk of hypertensive disorders of pregnancy: a multicenter cohort study in ovulatory women. Am J Obstet Gynecol MFM. 2023 Jan;5(1):100752. doi: 10.1016/j.ajogmf.2022.100752. Epub 2022 Sep 15.
von Versen-Hoynck F, Schaub AM, Chi YY, Chiu KH, Liu J, Lingis M, Stan Williams R, Rhoton-Vlasak A, Nichols WW, Fleischmann RR, Zhang W, Winn VD, Segal MS, Conrad KP, Baker VL. Increased Preeclampsia Risk and Reduced Aortic Compliance With In Vitro Fertilization Cycles in the Absence of a Corpus Luteum. Hypertension. 2019 Mar;73(3):640-649. doi: 10.1161/HYPERTENSIONAHA.118.12043.
Kornilov N, Polyakov A, Mungalova A, Yakovleva L, Yakovlev P. Progesterone-modified natural cycle preparation for frozen embryo transfer. Reprod Biomed Online. 2024 Nov;49(5):104350. doi: 10.1016/j.rbmo.2024.104350. Epub 2024 Jul 2.
Yuan HN, Song JY, Sun ZG. Comparison of progesterone-modified natural cycle and hormone replacement therapy cycle for endometrial preparation in single frozen blastocyst transfer (COMPROSET): protocol for an open-label randomized controlled trial. Front Med (Lausanne). 2025 Apr 28;12:1522004. doi: 10.3389/fmed.2025.1522004. eCollection 2025.
Other Identifiers
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P4mNC@SDUTCM
Identifier Type: -
Identifier Source: org_study_id
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