Clinical trial NCT06644794: Progesterone-modified Natural Cycle for FET
Official title: Comparison of Progesterone-modified Natural Cycle and Hormone Replacement Therapy Cycle for Endometrial Preparation in Single Frozen Blastocyst Transfer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Infertility, Female
Keywords: Progesterone-modified natural cycle
Hormone replacement therapy
Frozen-thawed embryo transfer
Lead sponsor: Shandong University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 336
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hormone replacement therapy (HRT) cycles, despite the ease of synchronizing embryo thawing and embryo transfer timing, increase the risk of pregnancies and obstetric complications compared to natural cycles (NC). By ensuring the presence of the corpus luteum while reducing the number of monitoring sessions, the progesterone modified natural cycle (P4mNC) offers more convenience for the patient than the normal NC. This study is designed to compare the effects of P4mNC and HRT cycles on FET outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients aged 21 to 44 years undergoing FBT
* Body mass index (BMI) 18-35 kg/m2
* Having regular ovulatory cycles

Exclusion Criteria:

* Untreated uterine adhesions
* Medical contraindications to estrogen and progesterone therapy
* Illnesses contraindicating assisted reproductive technology or pregnancy
* History of recurrent implantation failures (\> 2 embryo transfer failures)

Primary outcomes:
measure: Live birth
timeFrame: Within 1 year after randomization
Secondary outcomes:
measure: Biochemical pregnancy
timeFrame: Two weeks after embryo transfer
measure: Clinical pregnancy
timeFrame: Five weeks after embryo transfer
measure: Ongoing pregnancy
timeFrame: Ten weeks after embryo transfer
measure: Miscarriage
timeFrame: Within 28 weeks of pregnancy
Other outcomes:
Locations:
Study officials:
affiliation: Shandong University of Traditional Chinese Medicine
name: Zhen-Gao Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.